Abstract: OBJECTIVE: The aim of this study was to determine the natural history of vascular remodeling of atherosclerotic plaques in patients with type 2 diabetes and the predictors of vessel shrinkage. RESEARCH DESIGN AND METHODS: In this serial intracoronary ultrasound (IVUS) study, 237 coronary segments from 45 patients enrolled in the DIABETES I, II, and III trials were included. Quantitative volumetric IVUS analyses (motorized pullbacks at 0.5 mm/s) were performed in the same coronary segment after the index procedure and at the 9-month follow-up. Nontreated mild lesions (angiographic stenosis <25%) with > or =0.5 mm plaque thickening and length of > or =5 mm assessed by IVUS were included. Vessel shrinkage was defined as a Deltaexternal elastic membrane area/Deltaplaque area < 0. Statistical adjustment by multiple segments and multiple lesions per patient was performed. RESULTS: Vessel shrinkage was identified in 37.1% of segments and was associated with a significant decrease in lumen area at 9 months (vessel shrinkage, 10 +/- 4 mm(2) vs. non-vessel shrinkage, 11 +/- 4 mm(2); P = 0.04). Independent predictors of vessel shrinkage were insulin requirements (odds ratio 4.6 [95% CI 1.40-15.10]; P = 0.01), glycated hemoglobin (1.5 [1.05-2.10]; P = 0.02), apolipoprotein B (0.96 [0.94-0.98]; P < 0.001), hypertension (3.7 [1.40-10.30]; P = 0.009), number of diseased vessels (5.6 [2.50-12.50]; P < 0.001), and prior revascularization (17.5 [6.50-46.90]; P < 0.001). CONCLUSIONS: This serial IVUS study suggests that progression of coronary artery disease in patients with type 2 diabetes may be mainly attributed to vessel shrinkage. Besides, vessel shrinkage is influenced by insulin requirements and metabolic control and is associated with more advanced coronary atherosclerosis.

Abstract: OBJECTIVE: To assess the prevalence of low serum high-density lipoprotein cholesterol (HDL-C) concentration and the relationship between HDL-C and established cardiovascular disease (CVD) in an elderly Mediterranean population. METHODS: Analysis of Prevención del Riesgo de Ictus, a population-based study on Spanish subjects aged > or = 60 years. Low HDL-C was defined following the European guidelines for cardiovascular prevention [men: < 40 mg/dl (< 1.0 mmol/l); women: < 46 mg/dl (< 1.2 mmol/l)]. The relationship between low HDL-C or HDL-C concentration (in quintiles) and CVD was assessed through multivariate models that included cardiovascular risk factors, statins and subclinical organ damage. RESULTS: On 6010 subjects (71.7 years, 53.5% women), low HDL-C was present in 17.5% [95% confidence interval (CI): 16.5-18.5] and was more frequent in women [20.4% (19.0-21.8) vs. 14.1% (12.8-15.4) in men p < 0.001] and in patients with diabetes, CVD or statin therapy. Low HDL-C was independently associated with CVD [adjusted odds ratio (OR): 1.46, 95% CI: 1.22-1.74, p < 0.001]. The prevalence of CVD was higher as HDL-C concentration was lower (chi-square trend < 0.001). Compared with the highest quintile [> 65 mg/dl (> 1.67 mmol/l)], adjusted OR for CVD were 1.39 (1.10-1.76), 1.41 (1.11-1.80), 1.49 (1.18-1.89) and 1.91 (1.52-2.39), respectively for those in the fourth [57-65 mg/dl (1.46-1.67 mmol/l)], third [51-56 mg/dl (1.31-1.45 mmol/l)], second [46-50 mg/dl (1.18-1.30 mmol/l)] and first [< 46 mg/dl (< 1.18 mmol/l)] quintiles of HDL-C. This association was seen in males and females. CONCLUSIONS: A total of 17.5% of this Spanish population aged > or = 60 years had low HDL-C. We found a strong, independent and inverse association between HDL-C concentrations and established CVD, even at ranges of HDL-C considered as normal.

Abstract: AIMS: This prospective, open label, non-comparative, observational case series evaluates 6-month results of Pegaptanib Sodium (Macugen) and Photodynamic Therapy (PDT) in predominantly classic juxtafoveal choroidal neovascularisation (CNV) in age-related macular degeneration (AMD) in seven eyes of seven patients. RESULTS: Best corrected visual acuity (BCVA) diminished with a mean of five letters. Initial area of CNV increased significantly from 1.4 mm2 to 2.7 mm2. There was a significant increase in the greatest linear dimension (GLD) from 1280.3 microm to 2065.7 microm at the 24-week follow-up. CONCLUSION: Predominantly classic juxtafoveal CNVs are highly aggressive lesions that demonstrate poor response despite combined therapy using PDT and Macugen.

Abstract: Syphilis re-emergence is a cause of concern. Our objective was to quantify the laboratory workload, incident cases and patient follow-up that syphilis has generated for 11 years in a large teaching hospital. An ecologic study including all samples submitted for syphilis serodiagnosis at our hospital from January 1994 to December 2004 was undertaken. Our laboratory processed 58,832 samples for syphilis serodiagnosis. From 1994 to 2004, the number of samples submitted for syphilis testing dropped by 11% (95% confidence interval [CI] 10-12, p<0.001). Syphilis was diagnosed in 443 patients. The incidences were 11, 3 and 8 per 100,000 inhabitants/year in 1994, 2000 and 2004, respectively. Only 42% (185) of patients had repeat tests and in 79% (146) of cases, the 1-year follow-up data were missing. The median follow-up was 9 months (interquartile range [IQR] 3-26). We detected a reduction in the effort to detect syphilis, despite an increase in its incidence and the low cost of syphilis screening. Efforts should be intensified to improve physician compliance with syphilis screening and follow-up guidelines.

Abstract: INTRODUCTION: Epidemiological data on the incidence of cerebrovascular diseases in our country are scarce. A representative population-based study with a large denominator is required. AIM: To present the design of the study on stroke incidence in Spain, entitled Iberictus. SUBJECTS AND METHODS: We conducted a prospective, population-based study on the incidence of strokes and transient ischemic attacks, in which it is possible to distinguish: 1) population with a steady risk, which was well defined and had a broad denominator. We included all the cases in which the first episode of acute cerebrovascular disease was diagnosed among those over the age of 17 years (with no upper age limit) with their habitual residence in the areas of study between the 1st January and 31st December 2006: Lugo, Segovia, Talavera de la Reina, Mallorca and Almeria (total denominator, 1,440,997 inhabitants; minimum denominator per area, 100,000 inhabitants); 2) source of multiple and complementary data: hospital records (minimum basic data set, discharge abstracts), emergency and primary care records for the area with diagnostic codes 430-39 and 674.0 (International Classification of Diseases-9), population-based mortality records; 3) standardised definitions: diagnostic categorisation (MONICA-World Health Organisation, 1987), pathological classification (ischaemia, haemorrhagic), topography and aetiology; 4) presentation of data in suitable age groups, by sex and overall; 5) pilot study and analysis of inter-observer agreement among researchers. CONCLUSIONS: With this design, the Iberictus study satisfies the methodological criteria as an 'ideal' study of the incidence of acute cerebrovascular diseases proposed by Malgrem, Sudlow and Warlow, and represents a unique opportunity to further our knowledge of the epidemiology of strokes in our country.

Abstract: OBJECTIVE: To assess the relationship between different serum lipid profiles and the prevalence of established cardiovascular disease (CVD) in an elderly population. RESEARCH DESIGN AND METHODS: An analysis was undertaken of the PREV-ICTUS population-based study on Spanish subjects aged > or =60 years. The following definitions were used: abnormal LDL cholesterol (LDL-C): > or =130 mg/dl (> or =3.3 mmol/L), or > or =100 mg/dl (> or =2.5 mmol/L) in those with diabetes or CVD, or treatment with any hypolipidaemic drug; low HDL cholesterol (HDL-C): <40 mg/dl (<1 mmol/L) (men), or <50 mg/dl (<1.3 mmol/L) (women), and abnormal triglycerides (TG): > or =150 mg/dl (> or =1.7 mmol/L) or treatment with fibrates. We defined eight groups: A (normal lipid profile), B (isolated abnormal LDL-C), C (isolated abnormal TG), D (isolated low HDL-C), E (abnormal LDL-C and HDL-C), F (abnormal LDL-C and TG), G (abnormal TG and HDL-C), H (abnormal LDL-C, HDL-C and TG). A multivariate analysis was performed to assess the relationship between each lipid profile and CVD. RESULTS: A total of 6010 subjects (mean age 71.7 years, 53.5% women, 73.2% with hypertension, 29.2% with diabetes mellitus, 24.3% with CVD), were included in the analysis. LDL-C elevation was present in 78.1%, 23.3% had low HDL-C and 35.7% abnormal TG. Combined dyslipidaemias were frequent (40.3%). Odds ratios (95% confidence intervals) for CVD, compared with those with a normal lipid profile, were 2.07 (1.24-3.46) for abnormal HDL-C (p = 0.005), 4.09 (3.10-5.39) for abnormal LDL-C; 6.41 (4.59-8.95) for abnormal LDL-C plus HDL-C, 5.33 (3.98-7.14) for abnormal LDL-C plus TG and 7.59 (5.51-10.5) for those with the three parameters altered (all p < 0.001). Compared with those with isolated LDL-C elevation, those with abnormal LDL-C plus HDL-C had 1.57 (1.30-1.97) higher odds of having CVD (p < 0.001), the figures being 1.30 (1.11-1.53) for those with abnormal LDL-C plus TG and 1.86 (1.52-2.28) for those with abnormal LDL-C, TG plus HDL-C (p < 0.001). CONCLUSIONS: Lipid abnormalities are frequent in the elderly, and are associated with the presence of CVD. Low HDL-C and/or abnormal TG levels, when added to abnormal LDL-C, are associated with a higher prevalence of CVD, suggesting the advisability of a comprehensive lipid evaluation and treatment earlier in life.

Abstract: AIM: To analyze postnatal growth restriction in a cohort of very low birth weight (VLBW) infants with gestational age < or = 32 weeks in 55 Spanish neonatal units (SEN 1500 Network) during 2002 and 2003. METHODS: Weight, length and head circumference were recorded at birth, and at discharge. Weight was also recorded at 28 days postnatal, and 36 weeks of postmenstrual age. Growth restriction was measured as the shift in weight z score from birth to 28th day. RESULTS: The study included 2317 VLBW infants. Weight z score at birth, 28 days, 36 weeks of postmenstrual age and discharge were: -0.66 +/- 1.3, -2.54 +/- 1.35, -3.12 +/- 1.7, -1.56 +/- 1.1, respectively. Length z score at birth and at discharge were: -0.88 +/- 1.8, and -1.97 +/- 1.56. Head circumference z score at birth and at discharge: -0.83 +/- 1.87, and -0.60 +/- 1.96. Prenatal steroids, gestational age, place of birth, type of hospital, CRIB score, symptomatic patent ductus arteriosus and late-onset bacterial sepsis were related with the shift in weight z score at 28 days (multiple linear regression), but explained very little (14 %) of his change. Weight and length at discharge were under the 10th percentile in 77 % and 80 % of the infants, respectively. CONCLUSIONS: VLBW infants < or = 32 GA suffer postnatal growth restriction with respect to intrauterine growth pattern, which is more relevant in the first 28 days of life, in patients with more severe illnesses, and differs among neonatal units. Perinatal and neonatal items evaluated are poorly related with restriction.

Abstract: OBJECTIVE: To design and implement a registry of infants weighing less than 1,500 g at birth in Spain. MATERIAL AND METHODS: Prospective, cohort, multicenter study. All live born infants weighing less than 1,500 g in several voluntarily participating neonatal units in public and private hospitals were included. RESULTS: In the first 4 years of the registry (2002 to 2005), 9,638 very-low-birth-weight infants were born in the 65 neonatal units that have so far joined the program. CONCLUSIONS: The goal of very-low-birth-weight infant databases is to try to improve the quality and safety of the medical care given to these newborns and their families. This type of program helps to coordinate and promote several areas, including those of health education, training of medical staff, research and development, surveillance and quality improvement.

Abstract: OBJECTIVES: A meta-analysis of the literature was performed in this article in order to evaluate the diagnostic accuracy of 18F-FDG PET in suspected recurrent head and neck cancer. MATERIAL AND METHODS: A systematic review of the literature was performed using 1987 to 2007 MEDLINE and CANCERLIT databases, applying selection criteria to the studies found. Sensitivity, specificity, positive and negative likelihood ratios, and odds ratio were calculated. The diagnostic accuracy was evaluated with ROC (receive-operating-characteristics) curves. RESULTS: Nineteen articles were included in the meta-analysis. Sensitivity of 18F-FDG PET was 94 %, specificity 80 %, and the summary ROC curve showed a good trade-off between sensitivity and specificity. CONCLUSIONS: 18F-FDG PET was useful in patients with suspected recurrence of head and neck cancer, showing a high sensitivity and intermediate-high specificity.

Abstract: BACKGROUND: Treatment of patients with in-stent restenosis (ISR) remains a challenge. We sought to compare results of sirolimus-eluting stents (SES) with those of bare-metal stents (BMS) in patients with ISR. METHODS: The results obtained in the stent arm of two randomized studies were analyzed. The RIBS I study (450 patients with ISR) allocated 224 patients to BMS; the RIBS II study (150 patients with ISR) allocated 76 patients to SES. Complete 1-year follow-up was obtained in all 300 patients treated with stents. RESULTS: Although inclusion/exclusion criteria were identical in the two studies, when compared with patients in the BMS group, patients in the SES arm had more adverse baseline characteristics, more diffuse lesions, and smaller vessels. However, late angiographic findings including in-segment recurrent restenosis rate (11 vs. 38%, P < 0.001), minimal lumen diameter (2.52 vs. 1.63 mm, P < 0.001), and late loss (0.13 vs. 1.04 mm, P < 0.001) were significantly better after SES. The 1-year event-free survival was also significantly improved in the SES group (88 vs. 78%, P < 0.05), as the result of a lower requirement for repeated revascularizations (10.5 vs. 19.6%, P < 0.05). Prespecified subgroup analyses were consistent with the main outcome measures. After adjusting for (a) imbalances in baseline characteristics (restenosis OR 0.11 [95% confidence interval (CI) 0.03-0.36]; adverse events hazard ratios (HR) 0.33 [95% CI 0.13-0.84]) and (b) the propensity score (restenosis OR 0.08 [95% CI 0.03-0.28]; adverse events HR 0.24 [95% CI 0.09-0.66]), results of the SES group were superior to those obtained in the BMS group. CONCLUSIONS: When compared with BMS, SES improved the long-term clinical and angiographic outcome of patients with ISR.

Abstract: BACKGROUND: Studies on the impact of weight excess and fat distribution on blood pressure are usually limited to young and middle-aged population, and data on the elderly are scarce. METHODS AND RESULTS: We performed an analysis of the Prevencion de Riesgo de Ictus, a population-based study on individuals aged 60 years or more in Spain, to assess the impact of weight excess, stratified by body mass index (normal <25; overweight 25-29.9; obesity > or =30 kg/m), and waist circumference [increased if > or =88 cm (women) or > or =102 (men)] on the prevalence on hypertension and lack of blood pressure control. In 6263 individuals (mean age 71.9 years old, 53.3% women; 73.0% with diagnosed hypertension), prevalence of obesity was 35.0%, and 65.6% showed an increased waist circumference. Body mass index and waist circumference showed an independent impact on the prevalence and absence of hypertension control. In a multivariate model including age, sex, body mass index, and waist circumference, prevalence of hypertension was higher in the overweight and obesity groups (odds ratio 1.41 and 1.96, respectively, compared to normal weight), and in those with increased waist circumference (odds ratio 1.25) compared with normal waist circumference. After further adjustment for antihypertensive therapy, overweight, and obesity (odds ratio 1.40 and 1.59, respectively) as well as increased waist circumference (odds ratio 1.39) were independently related to absence of blood pressure control. The impact of waist circumference on hypertension and blood pressure control was shown in each category of body mass index. CONCLUSION: In this cross-sectional study in an elderly population, body mass index and waist circumference showed an independent and direct impact on the prevalence of hypertension and on the absence of blood pressure control.

Abstract: One year of once weekly alendronate, when given shortly after the surgical repair of a hip fracture, produces reductions in bone markers and increases proximal femoral bone density. The therapy was well tolerated. INTRODUCTION: Hip fracture is the most devastating type of osteoporotic fracture and increases notably the risk of subsequent fractures. The aim of this paper was to evaluate the effects of 1 year therapy with a weekly dose of alendronate in the bone mineral density and bone markers in elderly patients after low trauma hip fracture repair. METHODS: Two hundred thirty-nine patients (81 +/- 7 years; 79.8% women) were randomized to be treated either with calcium (500 mg/daily) and vitamin D(3) (400 IU/daily; Ca-Vit D group) or with alendronate (ALN, 70 mg/week) plus calcium and vitamin D(3) (500 mg/daily and 400 IU/daily, respectively; ALN + Ca-Vit D group). RESULTS: One hundred forty-seven (61.5%) patients completed the trial. Alendronate increased proximal femoral bone mineral density (BMD) in the intention-to-treat analysis (mean difference (95% confidence interval); total hip 2.57% (0.67; 4.47); trochanteric 2.96% (0.71; 5.20), intertrochanteric 2.32% (0.36; 4.29)), but the differences were not significant in the BMD of the femoral neck (0.47%; (-2.03; 2.96) and the lumbar spine (0.69%; (-0.86; 2.23)). Bone turnover markers decreased during alendronate treatment. CONCLUSION: The present study demonstrates for the first time the anti-resorptive efficacy of alendronate given immediately after surgical repair in an elderly population with recent hip fracture. This effect should positively affect the rate of subsequent fractures.

Abstract: We sought to describe neonatal morbidities and therapeutic interventions in very low-birth-weight (VLBW) and extremely low-birth-weight (ELBW) infants cared for in Spanish hospitals. We preformed a prospective collection of data covering the perinatal period until discharge by the SEN1500 network. This network, set up by the Spanish Society of Neonatology, targets VLBW and ELBW infants (400 to 1500 g) admitted to neonatal units in Spanish hospitals. Data were recorded in electronic form and controlled for possible errors or inconsistencies before analysis. We report data for 8836 neonates admitted to 48 neonatal units from January 2002 to December 2005. Prenatal steroids were given to significantly more newborns in 2003 to 2005 (79.4%) than in 2002 (73.4%), although the remaining perinatal data examined failed to significantly vary. Delivery was by cesarean section in 69.8% of cases but significantly lower (35.9%) for infants under a postmenstrual age of 26 weeks. Hyaline membrane disease was diagnosed in 53.9% of the newborns and bronchopulmonary dysplasia (BPD) in 10.46%. Mechanical ventilation was employed in 69.1%, surfactant in 50.3%, and steroids for BPD in 5.3%. Intraventricular hemorrhage grades 3 to 4 (8.1%) and cystic leukomalacia (2.6%) were the most relevant brain ultrasonography findings. Rates of early- and late-onset septicemia were 5% and 29.4%, respectively. Further diagnoses were necrotizing enterocolitis (NEC; 6.9%) and persistent ductus arteriosus (PDA; 24.2%); 40.6% of the cases of NEC and 15.3% of those of PDA required surgery. In addition, 26.6% of the newborns required supplementary oxygen at 28 days of life. The number of newborns who had not recovered their birth weight at this age fell from 3.1% in 2002 to 1.5% in 2005. Rates of prenatal steroid use, cesarean delivery, and main morbidities were comparable to figures cited for other patient series, although our BPD rate was among the lowest reported and nosocomial sepsis rate among the highest.

Abstract: The aim of this study is to assess the relationship among metabolic syndrome (MS), target organ damage (TOD) and established cardiovascular disease (CVD) in non-diabetic hypertensive elderly patients. ERIC-HTA is cross-sectional, multicentre study carried out in primary care, on hypertensive patients aged 55 or older. MS was defined by the NCEP-ATP III criteria, using body mass index (>28.8 kg/m(2)) instead of abdominal perimeter. In 8331 non-diabetic hypertensive patients (3663 men and 4668 women, mean age 67.7 years), the prevalence of MS was 32.6% (men: 29.0%; women: 36.8%). A linear association was observed between a greater number of components of MS and a greater prevalence of left ventricle hypertrophy (LVH) on the electrocardiogram (p<0.001), impaired kidney function (p<0.001) and established CVD (p = 0.001). In a multivariate model, MS in non-diabetic hypertensive patients was related to a greater prevalence of LVH (OR 1.31 [95% CI: 1.15-1.48]), impaired kidney function (OR 1.45 [95% CI: 1.29-1.63]) and established CVD (OR 1.22 [95% CI: 1.08-1.37]). This relationship persisted after stratifying by gender. In conclusion, in this elderly non-diabetic hypertensive population, the presence of MS was independently related to a greater prevalence of hypertensive TOD and established CVD, suggesting a role of MS as a cardiovascular risk marker in hypertension.

Abstract: INTRODUCTION AND OBJECTIVES: The aims of this study were to determine the prevalence of atrial fibrillation in individuals aged 60 years or more in Spain using a random sample of the population and to identify associated factors. METHODS: An analysis of the PREV-ICTUS study, a randomized cross-sectional population-based study of individuals aged 60 years or more, was carried out. Data on demographic variables, cardiovascular risk factors, and cardiovascular disease were obtained from medical records. The diagnosis of atrial fibrillation was based on the patient's medical history and an electrocardiogram performed during the study. RESULTS: In the 7108 individuals studied (mean age 71.9 [7.1] years, 53.6% female), the prevalence of atrial fibrillation was 8.5% (95% confidence interval [CI] 7.9-9.2%). It was higher in males (9.3% vs 7.9% in females; P=.036) and increased from 4.2% in individuals aged 60-64 years to 16.5% in those aged 85 years or more (chi-squared test for linear trend, P< .001). Multivariate analysis showed that existing cardiovascular disease, hypertension, age, and left ventricular hypertrophy had the strongest associations with atrial fibrillation. Although there was a strong relationship between hypertension and atrial fibrillation (odds ratio 2.53, 95% CI, 1.60-4.01), no association was found between poor blood pressure control and atrial fibrillation. A weak association with diabetes mellitus was found only when arterial pressure was included in the model, but not when a diagnosis of hypertension was included. CONCLUSIONS: In this cross-sectional population-based study of elderly individuals, the prevalence of atrial fibrillation was 8.5%, and was strongly associated with existing cardiovascular disease, hypertension, age and left ventricular hypertrophy.

Abstract: Reported data about the effect of the 4G/5G PAI-1 polymorphism on plasma PAI-1 levels are controversial. This study was designed to determine the relative effect of the 4G/5G PAI-1 polymorphism on high plasma PAI-1 levels after adjustment for metabolic syndrome - related variables, and to test if this effect is modified by the smoking status. Six hundred and thirty one unrelated subjects (292 men; 35-74 years), from a cross-sectional population-based epidemiological survey in the province of Segovia (Spain) were studied. The higher frequency of high PAI-1 levels was found in 4G/4G subjects (5G/5G 19.4%, 4G/5G 21.6%, 4G/4G 33.7%, p = 0.003). A multiple regression model, adjusted for gender, age, BMI, waist circumference, triglycerides, HDL-cholesterol, HOMA IR and leptin, showed this adjOR: 4G/4G vs 5G/5G: 2.22, p = 0.008. When smoking status - 4G/5G PAI-1 interaction was included as an independent variable these results were not modified. Our results indicate that the 4G/4G PAI-1 genotype might be strongly associated with high PAI-1 levels regardless of metabolic syndrome-related variables and smoking status.

Abstract: OBJECTIVE: To establish the prevalence of diabetic retinopathy (DR), types and risk factors in a diabetic population in the city of Badajoz. METHODS: A cross-sectional study, with prospective data collection, was performed in 2002 on 762 randomly selected diabetic patients belonging to two Primary Care Centers. We evaluated age, gender, type, treatment, duration of diabetes and blood pressure levels. Two color fundus photographs were taken and ophthalmoscopy performed on both eyes. Data were analyzed using SPSS (11.5). RESULTS: The mean age of the patients was 66.2 (DS 11.4) years, 4.7% were type 1 diabetics, 29% were insulin-treated and 52.8% had elevated blood pressure. Prevalence of DR was 29.8%, macular edema 1.4% and proliferative DR 4.8%. Multivariate analysis showed that patients with an evolution of between 5 and 10 years had a frequency 1.13 times higher (ORaj 1.13; IC 95% 0.68-1.88; p=0.648) than those of less than 5 years evolution, while those with more than 15 years evolution had a frequency 3.12 times higher (ORaj 3.12; IC 95% 1.85-5.26; p<0.001). Patients receiving treatment with oral antidiabetic agents had an RD prevalence 2.39 times higher (ORaj 2.39; IC 95% 1.21-4.74; p=0,012) than those treated with diet only. Patients treated with insulin had a 10.32 higher frequency (ORaj 10.32; IC 95% 5.07-21.00; p<0.001) than those treated with diet. CONCLUSIONS: 29.8% of the diabetic population in the city of Badajoz is affected by DR. Although this prevalence is lower than that observed in previous studies performed by the same team, further studies should be carried out to detect risk sub-groups to allow us to act to decrease such a high prevalence.

Abstract: BACKGROUND: Given the high risks associated with neonatal sepsis, there is a need for a diagnostic marker that would predict the disease before the results of blood or cerebrospinal fluid cultures are available. We evaluated changes in the CD4+ T lymphocyte immunophenotype in neonates with late-onset sepsis to try to improve the test combinations currently used (C reactive protein, immature:total neutrophil ratio, leukocytosis). PATIENTS AND METHODS: We performed a prospective cohort study in 24 neonates with late-onset sepsis and 48 non-infected controls with a gestational age of 37 weeks or less. CD4+ T lymphocyte subpopulations in peripheral blood samples were identified by labeling with monoclonal antibodies and quantified by flow cytometry. Diagnostic performance curves were constructed by logistic regression. RESULTS: As a marker of late-onset neonatal sepsis, a percentage of CD4+/CD45RO+/CD45RA- T lymphocytes of >3.5% showed a sensitivity of 94.1%, specificity of 69.2%, positive predictive value of 80.0%, negative predictive value of 90.0%, and odds ratio of 36.0 (p<0.001). When we combined this marker with a C-reactive protein level of >10.0 mg/L, the specificity of this combination of tests increased to 94.7% and the positive predictive value to 85.7%. CONCLUSIONS: A percentage of CD4+/CD45RO+/CD45RA- T lymphocytes of >3.5% is an effective indicator of late-onset neonatal sepsis in preterm infants. If this marker is combined with a C-reactive protein level of >10.0 mg/l, its diagnostic performance is improved.

Abstract:

Abstract: PURPOSE: To describe the incidence of retinal angiomatous proliferation (RAP) reactivation after combined treatment with a high-dose intravitreal triamcinolone acetonide (IVTA) and photodynamic therapy (PDT) at 1-year follow-up. METHODS: All patients had undergone a full ophthalmic examination. High-dose IVTA (20 mg) was injected via pars plana. Four to 7 days later, PDT was delivered. RESULTS: Fourteen eyes of 13 patients were included. Eight lesions (57%) reopened and needed retreatment with combined therapy at 6 months follow-up. At 1-year follow up, the lesion was obliterated in nine cases (64.2%) and best-corrected visual acuity improved from 0.87 logMar (range, 0.7-1) to 0.79 logMar (range, 0.5-1). CONCLUSIONS: Combined therapy using high-dose IVTA and PDT is beneficial in stabilizing RAP. However, a high incidence of RAP reactivation has been observed at 6 months, even with a high-dose IVTA injection.

Abstract: OBJECTIVE: Analysis of infectious complications and risk factors in percutaneous central venous catheters. DESIGN: One-year observational, prospective, multicenter study (1998-1999). SETTING: Twenty Spanish pediatric intensive care units. PATIENTS: Eight hundred thirty-two children aged 0-14 years. INTERVENTION: None. MEASUREMENTS AND MAIN RESULTS: One thousand ninety-two catheters were analyzed. Seventy-four (6.81%) catheter-related bloodstream infections (CRBSI) were found. The CRBSI rate was 6.4 per 1,000 CVC days (95% CI 5.0-8.0). Risk factors for CRBSI were weight under 8 kg (p < 0.001), cardiac failure (RR 2.69; 95% CI 1.95-4.38; p < 0.001), cancer (RR 1.66; 95% CI 0.97-2.78; p=0.05), silicone catheters (RR 2.82; 95% CI 1.49-5.35; p = 0.006), guidewire exchange catheterization (p=0.002), obstructed catheters (RR 2.67; 95% CI 1.63-4.39; p<0.001), and more than 12 days' indwelling time (RR 5.9; 95% CI 3.63-9.41; p<0.001). Multivariate Cox regression identified lower patient weight (HR 2.4; 95% CI 1.11-5.19; p=0.002), guidewire exchange catheterization (HR 2.2; 95% CI 1.07-4.54; p=0.049) and more than 12 days' indwelling time (HR 1.97; 95% CI 0.89-4.36; p=0.089) as significant independent predictors of CRBSI. Factors which protected against infection were the use of povidone-iodine on hubs (HR 0.42; 95% CI 0.19-0.96; p=0.025) and porous versus impermeable dressing (HR 0.41; 95% CI 0.23-0.74; p=0.004). Two children (0.24%) died from endocarditis following catheter-related sepsis due to Stenotrophomonas maltophilia in one case and P. aeruginosa in the other. CONCLUSIONS: Catheter-related sepsis is associated with lower patient weight and more than 12 days' indwelling time, but not with the insertion site. Cleaning hubs with povidone-iodine protects from infection.

Abstract: BACKGROUND AND OBJECTIVE: To assess the prevalence of low glomerular filtration rate (GFR < 60 ml/min/1.73 m2) in general population of subjects aged 60 years or older of Spain, and the related factors. PATIENTS AND METHOD: Analysis of PREV-ICTUS, a population-based study carried out in a sample of subjects aged 60 years or more, randomly selected and stratified by Autonomic Communities according to the census of inhabitants and the habitat in each Community. Demographic data, cardiovascular risk factors and diseases were collected. GFR was calculated using the MDRD (Modification of Diet in Renal Disease) equation. RESULTS: In 6,799 subjects (age 71.9 years-old; 53.6% women; 72.9% with arterial hypertension [HT]; 27.0% with diabetes mellitus [DM]; 24.3% with cardiovascular disease), 25.9% had low GFR (95% confidence interval, 24.8-26.9). The prevalence increased linearly, from 16.5% in subjects aged 60-64 years to 46.5% in those aged 85 or more (p < 0.001), and was higher in women (36.1% vs 14.1% in men, p < 0.001). In the multivariate analysis, low GFR was independently related to advanced age (odds ratio [OR] between 1.30 y 4.20), female gender (OR = 5.82), HT older than 7 years (OR = 1.23), uric acid (OR = 1.52 for each increment of 1 mg/dl) and cardiovascular disease (OR = 1.68). The association with DM did not reach statistical significance. In a model without cardiovascular disease, related factors remained the same, increasing the significance of HT older than 7 years (OR = 1.31) and of DM (OR = 1.19). CONCLUSION: One out or 4 subjects of this sample showed low GFR. The variables directly associated with low GFR were advanced age, female gender, HT of longer evolution, cardiovascular disease, increased uric acid, and, in one model, DM.

Abstract: AIMS: Atrial fibrillation patients with prior embolism have a high risk of vascular events in spite of anticoagulant therapy and elderly patients carry an additional risk. We analysed and compared vascular events-rate between older and younger than 75 years atrial fibrillation patients randomized to anticoagulant-alone or combined antiplatelet plus moderate-level anticoagulant therapy. METHODS AND RESULTS: A total of 967 patients stratified by age and the history of prior embolism were randomized to therapeutic doses of anticoagulant-alone or combined antithrombotic therapy. Primary events were fatal and non-fatal ischaemic or haemorrhagic stroke/transient ischaemic attack, systemic embolism and myocardial infarction, sudden death and death from bleeding. The elderly, compared with the younger patients, had higher event-rate [hazard ratio 2.31 (95% confidence interval 1.37-3.90), P < 0.003]. The elderly suffered higher severe bleeding event-rate during anticoagulant therapy. The combined, compared with the anticoagulant therapy, reduced the vascular events-rate in the elderly (P = 0.012) and caused less intracranial haemorrhages and less bleeding mortality, although more non-fatal gastric bleeding. CONCLUSION: The elderly with AF had a higher event-rate than the younger patients. A higher severe bleeding event-rate was also registered in elderly patients receiving anticoagulant therapy. Combined, compared with anticoagulant therapy, significantly reduced vascular events and bleeding mortality in elderly patients.

Abstract: AIMS: Sirolimus stent implantation has been demonstrated to be safe and effective in diabetics; however, the long-term outcomes in this high-risk population remain unknown. The aim of this study was to determine the long-term safety and efficacy of the sirolimus-eluting stent (SES) when compared with the bare metal stent (BMS) in patients included in the DIABETES (DIABETes and sirolimus Eluting Stent) trial. METHODS AND RESULTS: The prospective multicentre DIABETES trial randomized 160 diabetic patients with one or more significant coronary stenoses in one, two, or three vessels to either SES or BMS implantation. One-year dual antiplatelet therapy (aspirin plus clopidogrel) was routinely prescribed. Clinical follow-up was scheduled at 1, 9, 12, and 13 months and 2 years. Baseline clinical and angiographic characteristics were comparable between groups. At 2 years, the rate of target lesion revascularization was significantly lower in the SES group compared with the BMS group (7.7 vs. 35.0%, P < 0.001). However, the total revascularization rate at 2 years increased in both groups due to progression of atherosclerosis in coronary segments remote from the target lesion (rate of atherosclerosis progression: 7.7% in SES group vs. 10% in BMS group; P = 0.7). During dual antiplatelet treatment (1 year), there was no stent thrombosis in the SES group, whereas two patients presented it in the BMS group. However, after clopidogrel withdrawal, three patients allocated to the SES group presented stent thromboses vs. none in the BMS group. CONCLUSION: SES implantation in diabetic patients remains effective at 2-year follow-up. However, clinical efficacy appeared to be reduced by the occurrence of stent thrombosis between 1 and 2 years.

Abstract: PURPOSE: An alteration in corneal innervation has been described in dry eye associated with diabetes mellitus, contact lens use, and LASIK. The purpose of this study was to evaluate whether dry eye not related to Sjögren's syndrome (NSDE) and dry eye related to primary Sjögren's syndrome (PSDE) are associated with an alteration of the corneal nerves and sensation. METHODS: Twenty-one patients with dry eye (10 NSDE and 11 PSDE) and 20 healthy volunteers were studied. Healthy volunteers were divided into two groups: one younger than 60 years (N<60) and the other 60 years of age or older (N> or =60). The study of the epithelium, stroma, and subbasal corneal nerves was performed with a confocal microscope. Mechanical, chemical, and thermal sensation was evaluated using the Belmonte noncontact esthesiometer. RESULTS: A statistically significant decrease in the number and density of subbasal nerves (P < 0.0001) and the density of superficial epithelial cells (P < 0.0001) was observed in dry eyes. The number and density of subbasal nerves was higher in the N<60 group. A significant decrease was found with respect to mechanical, chemical, and thermal sensitivity (P < 0.0001). Sensibility was better in the healthy eyes. A strong correlation was found between the density of superficial epithelial cells and the nerves and between the number and density of subbasal nerves and sensation (P < 0.001). CONCLUSIONS: The use of confocal microscopy and noncontact esthesiometry allow the detection of the presence of corneal neuropathy in patients with dry eye.

Abstract: BACKGROUND: Estrogen loss has been related to higher incidence of stroke in postmenopausal women, but randomized trials have demonstrated an increased risk of stroke in women receiving hormone replacement therapy (HRT). OBJECTIVE: To assess the relationship between exposure to endogenous ovarian hormones and the risk of noncardioembolic ischemic stroke. METHODS: We conducted a multicenter, age-matched, case-control study in postmenopausal women (case: nonembolic ischemic stroke; control: no stroke) comparing duration of ovarian activity or lifetime estrogen exposure, which was defined as age at menarche to age at menopause. Embolic cardiopathy and unreliable gynecologic data were exclusion criteria. Cardiovascular disease risk factors were recorded. The relationships of the principal variables to the risk of stroke were assessed using a conditional logistic regression analysis. RESULTS: There were 430 cases and 905 controls in the study. In the multivariate analysis, hypertension (odds ratio [OR]: 2.73; 95% CI: 2.09 to 3.58; p < 0.0001), diabetes (OR: 3.38; 95% CI: 2.53 to 4.52; p < 0.0001), hyperlipidemia (OR: 1.31; 95% CI: 1.01 to 1.7; p = 0.045), lifespan of ovarian activity <34 years (OR: 1.51; 95% CI: 1.13 to 2.03; p = 0.005), and menarche at <13 years of age (OR 1.49; 95% CI: 1.15 to 1.92; p = 0.002) were independently related to an increased risk of stroke. Obesity (OR: 0.73; 95% CI: 0.56 to 0.95; p = 0.021) was related to a lower risk of stroke. CONCLUSIONS: Longer lifetime exposure to ovarian estrogens may protect against noncardioembolic ischemic stroke. However, a very early age of exposure onset could be disadvantageous.

Abstract: AIMS: Controversy exists about the clinical significance of in-stent late loss (ISLL) after drug-eluting stent (DES) implantation. We sought to clarify whether ISLL after DES implantation is related to a potential clinical impact. METHODS AND RESULTS: We included in a meta-regression analysis 21 trials (8641 patients) that randomly compared DES with bare-metal stents (BMS). We evaluated the relationship between angiographic behaviour of DES and the clinical impact of using DES instead of BMS in each trial using meta-regression techniques, weighting by the number of patients included in each trial. Mean ISLL in patients allocated to DES and DeltaISLL (difference in ISLL in patients allocated to BMS and DES) were used as angiographic parameters of efficacy of DES. The number of patients needed to be treated (NNT) to prevent one target lesion revascularization (TLR) was used to quantify the clinical impact of using DES instead of BMS. There was a significant relationship between mean ISLL in patients allocated to DES and the clinical benefit of using DES instead of BMS, as measured with the NNT for TLR: NNT for TLR = 6.2 + 18.4 [ISLL-DES] (R = 0.62; P = 0.007). Therefore, a 0.1 mm increase in mean ISLL-DES was associated with a 1.8 increase in NNT for TLR. There was also a significant association between the degree of inhibition of neointimal hyperplasia of DES in comparison with BMS with the NNT for TLR: NNT for TLR = 17.1-11.8 [DeltaISLL] (R = 0.61; P = 0.008). Therefore, a 0.1 mm reduction in ISLL by using DES instead of BMS was associated with a 1.2 decrease in mean NNT for TLR. CONCLUSION: There is a strong and significant association between the degree of inhibition of neointimal formation with the use of DES and the clinical impact of using DES instead of BMS.

Abstract: We have investigated whether the -86 C/T promoter polymorphism in CHRNA7 gene, the signal peptide polymorphism of the alpha1-antichymotripsin (ACT) gene or the APOE genotype are associated with an increased risk of mild cognitive impairment (MCI) or affect the risk of evolution to Alzheimer's disease (AD). We have followed up 89 patients with initial diagnoses of amnestic MCI for 49 months. Patients were separated into three groups: 27 subjects who remained with MCI, 40 that converted to AD before 20 months and 22 that converted to AD after. To assess the risk associated to each genotype a control group (n=90) without cognitive impairment was included. APOE4 allele was associated with an increased risk of MCI (OR: 6.04, 95% CI: 2.76-3.23; p<0.001) but did not have an effect on the probability of evolving AD. ACT or CHRNA7 genotypes were not associated with MCI but both appear to modify the risk of progression to dementia in opposing manners: ACT polymorphism increasing the risk to evolve to AD before 20 months (HR=2.03; 95% CI: 1-4.6; p=0.06) and CHRNA7 polymorphism protecting from evolution to dementia. Cox regression model demonstrated that ACT genotype confers a higher risk of rapid evolution to dementia than age or years of schooling. We conclude that APOE is a risk gene for amnestic MCI and that ACT and CHRNA7 may act in these patients as modifier genes for the time of progression to AD.

Abstract: Proximal duodenal-ileal end-to-side bypass with sleeve gastrectomy is a new bariatric technique based on the biliopancreatic diversion with duodenal switch in which after the sleeve gastrectomy, the duodenum is anastomosed to the ileum in a Billroth-II fashion. A 200-cm common channel-alimentary limb is devised. Anticipating an appropriate weight loss, at least similar to that obtained after gastric bypass, theoretical benefits for operated patients are a shorter operative time, the performance of only one anastomosis, and no mesentery opening. A prospective trial is now being conducted to find out the results of the procedure and to compare them to those obtained with gastric bypass and standard duodenal switch.

Abstract: INTRODUCTION: 18F-FDG PET has demonstrated its usefulness in detecting recurrences of differentiated thyroid cancer (DTC) with high thyroglobulin (Tg) levels and negative 131I whole-body scan (WBS); however, the number of patients analyzed is low and different studies report disparate results. OBJECTIVE: To estimate the diagnostic accuracy of 18F-FDG PET in this subgroup of patients. MATERIALS AND METHODS: Fifty eight patients (64 18F-FDG PET studies) with histologically proven DTC treated with total thyroidectomy followed by at least one session of 131I therapy for the ablation of thyroid remnants were retrospectively analyzed. Results were verified by pathology, clinical follow-up, response to treatment, or by comparison with conventional diagnostic methods. Sensitivity (Se), specificity (Sp), likelihood ratios (LR), diagnostic accuracy (DA), positive and negative predictive values (PPV, NPV), and Tg levels were calculated for patients with positive and negative 18F-FDG PET results. RESULTS: Twenty seven studies were true positives, 1 false positive, 25 true negatives, and 11 false negatives. Se was 71 %, Sp 96 %, PPV 96.4 %; NPV 69.4 %, DA 81.3 %, positive LR 17.75, and negative LR 0.3. The mean Tg level was 202.34 ng/ml in patients with positive 18F-FDG PET and 40.94 ng/ml in those with negative 18F-FDG PET; the difference between the two groups (161.4 ng/ml) was significant at p <0.05. CONCLUSIONS: 18F-FDG PET is a useful for detecting residual or recurrent DTC in patients with elevated Tg and negative 131I WBS.

Abstract: The only clinical benefit of drug-eluting stents (DESs) over bare metal stents (BMSs) is a significant decrease in the need for new revascularization procedures. We evaluated whether DESs also decrease the incidence of myocardial infarction at midterm. We performed a meta-analysis from 25 randomized trials comparing commercially available DESs with BMSs that included 9,791 patients overall. There was no heterogeneity across the trials included (Q test for heterogeneity, p = 0.68). Of the 9,791 patients included in all the trials, 364 developed an acute myocardial infarction during follow-up (6 to 12 months). The risk of myocardial infarction was significantly lower in patients allocated to DESs (3.3% vs 4.2% in those allocated to BMSs, odds ratio 0.79, 95% confidence interval 0.64 to 0.97, p = 0.03). In conclusion, the significant decrease in angiographic restenosis associated with the use of DESs leads not only to a decreased need for subsequent revascularization procedures but also a decreased incidence of myocardial infarction during the first 12 months after stent implantation.

Abstract: INTRODUCTION AND OBJECTIVES: The aim of this study was to describe the changes observed in clinical practice in our interventional cardiology unit over the last 20 years. METHODS: Between January 1, 1986 and December 31, 2005, >or=17,204 percutaneous transluminal coronary angioplasties (PTCAs) were performed at our center. They were analyzed in four periods of 5 years each. After each procedure, prospective data on patient, procedural, and outcome variables were recorded. The data were analyzed with regard to when the procedure was performed, and the patients' sex and age (i.e., < or >or=75 years). Data from 2006 were used as a reference, but were not included in the analysis. RESULTS: The number of PTCAs increased significantly. Over the time period, mean patient age increased (from 57[10] years to 62[12] years for males and from 66[10] years to 70[11] years for females), and there were significant increases in the proportions of women (from 16% to 22%) and patients aged >75 years (from 7% to 22%). Among men, the incidence of smoking decreased while that of hypertension, diabetes and hyperlipemia increased. Among women, however, there was no change in risk factors. The numbers of urgent and emergent procedures (17% of PTCAs were for acute myocardial infarction in 2006) increased in both sexes and age groups, more ad hoc procedures were carried out, and more lesions were treated, usually with a stent. Over time, the success rate increased and the complication rate decreased in both sexes and age groups. In-hospital mortality for all procedures, except those for acute myocardial infarction, was 0.7% in males and 1.4% in females (P=.012). CONCLUSIONS: Significant changes were observed over the last 20 years in the baseline characteristics of, the techniques used in, and the outcomes obtained in patients undergoing percutaneous coronary intervention.

Abstract: INTRODUCTION AND OBJECTIVES: Physiological and hypotonic saline solutions have been used interchangeably for preventing contrast media nephrotoxicity. No analysis of the possible differential effects of the two solutions on the milieu interieur or intercompartmental fluid volumes has been performed. Our aim was to study the systemic and renal effects of two types of saline solution regularly used to prevent contrast media nephrotoxicity in patients undergoing coronary angiography. METHODS: Changes in electrolyte levels and volume distribution were studied in 71 individuals who were randomized to receive either 0.9% isotonic saline (n=36) or 0.45% hypotonic saline (n=35) during the 12 hours before and after contrast injection (2000 mL in each period). RESULTS: The creatinine level was elevated equally often in the isotonic and hypotonic saline groups. Isotonic saline administration led to reductions in hemoglobin level, hematocrit and plasma albumin level, and to increases in plasma volume, by 12.3% and 10.4% at 24 and 48 hours, respectively. These changes were significant compared with baseline measurements and compared with the group that received hypotonic saline. Neither of the two saline solutions resulted in a change in plasma atrial natriuretic peptide level. Plasma and urine osmolality decreased only with hypotonic saline. The increase in plasma creatinine level was similar with both isotonic and hypotonic saline. CONCLUSIONS: During standard therapy for preventing contrast media nephrotoxicity, (1) isotonic saline, but not hypotonic saline, increased plasma volume; (2) this increase did not raise the atrial natriuretic peptide level; and (3) no difference in the increase in serum creatinine level was observed between the two saline solutions. These findings provide evidence that 0.45% saline, at a dose suitable for preventing contrast media nephrotoxicity, is associated with a lower risk of volume expansion. This result is important for patients with severely impaired ventricular function.

Abstract: The purpose of this study was to analyze the mortality and its prognostic factors in a Spanish cohort of very low birthweight (VLBW) infants during the period 2002 to 2005. Using the Spanish Society of Neonatology database (SEN 1500), 8942 infants with a birthweight < 1500 g were recruited. The overall mortality was 17.3%. However, this incidence underwent a significant decrease over the study period, from 19.4% in 2002 to 15.2% in 2005 ( P = 0.003). Mortality ranged from 12.4% in 25% of the participating neonatal units to 19.4% in a further 25%. Mortality was higher in outborn infants (25.8%) than in inborn infants (16.6%) ( P < 0.001). The mortality rates of these neonates are also presented by 100-g intervals (401 to 1500) and for the different hospitalization times: in the delivery room, within 24 hours and 28 days of birth, at 36 weeks of postmenstrual age, and on discharge. Of note was that mortality was greatest within 24 hours and 28 days of birth in each of the weight groups ( P < 0.001). In conclusion, in the cohort of infants < 1500 g examined, mortality in the period from 2002 to 2005 was still high, especially among newborns weighing < 1000 g. We did, however, observe a decreasing trend in mortality rates for the participating neonatal units over the 4 study years. Our findings highlight the need to promote intrauterine transport and improve neonatal transport as well as the management of these infants in the delivery room and within the first 28 days of life.

Abstract: Blood pressure (BP) control at recently established goals of <130/80 mm Hg is often difficult to achieve in diabetic patients. This work examines the effect of pioglitazone on 24-hour ambulatory BP monitoring in patients with type 2 diabetes and difficult-to-control hypertension. Twenty-seven participants with difficult-to-control hypertension (defined as ambulatory BP monitoring >or=125/75 mm Hg) taking antihypertensive medications (mean, 4.1+/-0.8 drugs) were enrolled in an open, prospective, blinded end point study of add-on therapy with pioglitazone 30 to 45 mg for 20 weeks. After 20 weeks of treatment, 24-hour ambulatory BP monitoring showed significant reductions (from 144+/-13 to 136+/-16 mm Hg systolic BP and from 79+/-9 to 76+/-10 mm Hg diastolic BP [P=.001]). Treatment was also associated with improvements in insulin sensitivity and glycemic and lipid profile. These findings suggest that pioglitazone could be a therapeutic option in diabetics who still have elevated BP values in spite of receiving treatment with at least 3 antihypertensive drugs.

Abstract: Stroke is the leading cause of mortality in women in Spain. RIMHA is a cross-sectional multicenter study in hypertensive women aged 55 or more in primary care to estimate the 10-year risk for a first stroke. Clinical history, cardiovascular risk factors and diseases, electrocardiogram, blood samples and blood pressure (BP) were recorded. Stroke and coronary risk were estimated using the appropriate Framingham scales; 12875 patients were included (mean age 68.0+/-8.5 years, 29.1% with diabetes, 19.7% with cardiovascular disease). Electrocardiographic left ventricular hypertrophy (LVH) was present in 19.2% BP was controlled in 42.9% of non-diabetic (BP<140/90 mmHg) and 9.7% of diabetic patients (BP<130/80 mmHg). The 10-year risk (+/- SD) for a first stroke was estimated as 15.8+/-16.3%, and the coronary risk as 12.0+/-6.3. In the multivariate analysis, the most contributing factors for stroke risk estimation were age, systolic BP, LVH and atrial fibrillation. In conclusion, the 10-year estimated stroke risk for Spanish hypertensive women aged 55 years or more was higher than the estimated coronary risk, in accordance with the high rates of morbidity and mortality due to stroke among women in Spain. The most powerful risk factors were older age, poor BP control, LVH and atrial fibrillation.

Abstract: BACKGROUND: Target organ damage (mainly cardiac and renal damage) is easy to evaluate in outpatient clinics and offers valuable information about patient's cardiovascular risk. The purpose of this study was to evaluate, using simple methods, the prevalence of cardiac and renal damage and its relationship to the presence of established cardiovascular disease (CVD), in patients with hypertension (HT) and type 2 diabetes mellitus (DM). METHODS: The RICARHD study is a multicentre, cross-sectional study made by 293 investigators in Nephrology and Internal Medicine Spanish outpatient clinics, and included patients aged 55 years or more with HT and type 2 DM with more than six months of diagnosis. Demographic, clinical and biochemical data, and CVD were collected from the clinical records. Cardiac damage was defined by the presence of electrocardiographic left ventricular hypertrophy (ECG-LVH), and renal damage by a calculated glomerular filtration rate (GFR) of <60 ml/min/1.73 m2, and/or the presence of an albumin/creatinine ratio > or = 30 mg/g; or an urinary albumin excretion (UAE) > or = 30 mg/24 hours. RESULTS: 2339 patients (mean age 68.9 years, 48.2% females, 51.3% with established CVD) were included. ECG-LVH was present in 22.9% of the sample, GFR <60 ml/min/1.73 m2 in 45.1%, and abnormal UAE in 58.7%. Compared with the reference patients (those without neither cardiac nor renal damage), patients with ECG-LVH alone (OR 2.20, [95%CI 1.43-3.38]), or kidney damage alone (OR 1.41, [1.13-1.75]) showed an increased prevalence of CVD. The presence of both ECG-LVH and renal damage was associated with the higher prevalence (OR 3.12, [2.33-4.19]). After stratifying by gender, this relationship was present for both, men and women. CONCLUSION: In patients with HT and type 2 DM, ECG-LVH or renal damage, evaluated using simple methods, are associated with an increased prevalence of established CVD. The simultaneous presence of both cardiac and renal damage was associated to the higher prevalence of CVD, affording complementary information. A systematic assessment of cardiac and renal damage complements the risk assessment of these patients with HT and type 2 DM.

Abstract: BACKGROUND: We investigated whether interactions of the -308G/A polymorphism in the promoter region of the tumor necrosis factor-alpha (TNF-alpha) gene with single-nucleotide polymorphisms (SNPs) 45 and 276 of the adiponectin gene are associated with circulating adiponectin and soluble TNF-alpha receptor 2 (sTNFR2) concentrations in a Spanish population. METHODS: We performed anthropometric and physiologic measurements in 809 unrelated participants recruited with a simple random sampling approach from respondents to a cross-sectional population-based epidemiologic survey in the province of Segovia in central Spain (Castille). RESULTS: The 2-h postload glucose and serum insulin concentrations were higher in -308A allele carriers than in -308G/G individuals homozygous for the TNF-alpha gene. Plasma concentrations of sTNFR2 were positively correlated with body mass index, waist-to-hip ratio, and sagittal abdominal diameter among individuals with type 2 diabetes. Individuals with type 2 diabetes and the -308A allele had higher sTNFR2 and lower adiponectin concentrations than -308G homozygotes. Moreover, individuals carrying both the TNF-alpha -308A allele and the G allele of SNP 45 in the adiponectin gene had the highest prevalence of impaired glucose tolerance (adjusted odds ratio, 1.26; 95% confidence interval, 1.01-1.56; P = 0.038) and had lower adiponectin concentrations (beta = -0.090; P = 0.005) than individuals without these genotypes. CONCLUSIONS: Our findings are the first to indicate that a higher incidence of impaired glucose tolerance and low circulating adiponectin concentration may be associated with interaction between the -308G/A promoter polymorphism of the TNF-alpha gene and SNP 45 in the adiponectin gene.

Abstract: OBJECTIVES: Fever in hospitalized patients (FHP) is a difficult problem. We study clinical characteristics and predictive parameters of infection, sepsis and outcome. PATIENTS AND METHODS: Prospective study of 204 patients with fever > 38 degrees C admitted in an Internal Medicine ward. In each patient clinical evaluation, complete blood count (CBC) urinalysis (UA), C-reactive protein (CRP), chest X- ray (CXR), blood and urine cultures were performed. RESULTS: 115 patients suffered infection (75.9% nosocomial, 7.4% sepsis), 35 had a non-infectious etiology and 54 an unknown cause. CBC and CRP did not distinguish infection, bacteremia or sepsis. In UA, positive nitrites, leukocytes and bacteriuria were predictive of infection. 18.6% of the patients were diagnosed by CXR. 18% of urine cultures and 13% of blood cultures were positive. 71.6% received antibiotics (deemed unnecessary in 18%). Microbiological results modified 25% of initial treatments. Average hospital stay was 17 days; 16.7% died. Chronic lung disease, fever duration, dysphagia and urinary tract alterations predict infection. Obesity, diabetes mellitus, liver failure, immunocompromised host, central vascular access, fever duration and nosocomial infection predict bacteremia. Sepsis is more prevalent in males, with malignancy and vascular or nosocomial infection. Chronic liver disease, nosocomial infection, severe lung infection and sepsis increase mortality. CONCLUSIONS: Clinical diagnosis of FHP is inaccurate. Infection is it s most frequent cause; UA, CXR, and blood and urine cultures are useful. FHP increases mortality and hospital stay. We have established predictable models of infection, bacteremia, sepsis and mortality. However, its sensibility and specificity are low.

Abstract: We carried out a 4-year study of 159 children (ages 1 month-14 years) with pneumococcal meningitis. The study was divided into two periods: the retrospective period (1998-2000: 107 patients), and the prospective period (2001-2002: 52 patients). About 2/3 of the children were under 2 years of age: 72 (45%) were under 1 year of age and 38 (24%) had meningitis during the second year of life. One-third of the patients had signs of otitis media; convulsions were more frequent in patients under 1 year compared with older patients (34.7 vs. 14.9%; P=0.004); 13/159 children (8.2%) died; 93/159 (58.5%) recovered completely, 12.6% had motor sequelae, 6.9% hydrocephalus, 29.8% sensorineural hearing loss; 140/159 (88%) were treated with third generation cephalosporins, yet only 8.7% of the pneumococci identified were completely penicillin-resistant (> or =1 microg/ml); 119/159 were treated with dexamethasone. Four patients had received an injection of heptavalent vaccine. Antibiotics for 1 week prior to admission, shock, abnormal pupils, leukocytes count <6,000 mm(3), and CSF glucose < or =8.5 mg/dl were significantly associated with poor outcome and/or death in the univariate analysis. No patient with leukocytosis >16,000/mm(3) died. Conclusion. Sequelae are very common in pneumococcal meningitis. Poor outcome was associated with pupillary abnormality and a leukocyte count <6,000/mm(3) on admission. Leukocytosis was protective against poor outcome.

Abstract: Lipodystrophy (lipo) and metabolic derangements associated with an increased cardiovascular risk are observed frequently in human immunodeficiency virus (HIV)-infected patients who receive antiretroviral treatment (ART). The objective of the study was to provide detailed biochemical information about metabolic syndrome in this condition. One hundred forty-six HIV-infected male and female patients on ART for more than 6 months were compared with 156 body mass index (BMI)-matched healthy subjects. Lipodystrophy was diagnosed upon patient and physician concordance. Metabolic syndrome was defined according to the Adult Treatment Panel III criteria. Plasma adiponectin (AD) and leptin were measured by radioimmunoassay. Insulin resistance (IR) was assessed by the homeostasis model assessment (HOMA). The prevalence of metabolic syndrome was higher in HIV-infected patients on ART than in non-HIV-infected healthy controls (15.8% vs 3.2%; P < .001). Patients with metabolic syndrome are older (44.6 +/- 6 vs 39.8 +/- 8 years; P = .004), have an increased BMI (24.9 +/- 3.8 vs 22.9 +/- 9.8 kg/m(2); P = .01), present with a reduced AD-to-leptin ratio log(10) (-0.19 +/- 0.4 vs 0.5 +/- 0.4; P = .04), and show increased IR (HOMA, 5.6 +/- 2.7 vs 3.8 +/- 2.2; P = .001; plasma fasting insulin, 22.9 +/- 9.8 vs 16.6 +/- 9.7 ng/mL; P < .001). In multivariate analysis, the diagnosis of lipo and HOMA were independently and significantly related to metabolic syndrome. In conclusion, the prevalence of metabolic syndrome is significantly increased in HIV-infected patients on ART and its presence is associated with lipo, increased age and BMI, IR, and a reduced plasma AD-to-leptin ratio.

Abstract: OBJECTIVES: A predefined intravascular ultrasound (IVUS) substudy was performed to evaluate the vascular effects of sirolimus-eluting stent (SES) versus bare-metal stent (BMS). BACKGROUND: The Diabetes and Sirolimus-Eluting Stent (DIABETES) trial is a prospective, multicenter, randomized, controlled trial aimed at demonstrating the efficacy of the SES compared with BMS in diabetic patients. METHODS: Serial intravascular ultrasound analyses were performed in 140 lesions (SES = 75; BMS = 65) immediately after stent implantation and at nine-month follow-up. Vessel, luminal, and stent mean areas and volumes were evaluated at both edges and within the stented segment. Qualitative assessment of residual dissections and stent apposition were also performed. RESULTS: Baseline clinical and angiographic characteristics were similar between groups. At 9 months, in-stent neointimal hyperplasia (NIH) mean area and volume were significantly reduced in the SES group (median NIH area 0.01 mm2 [0.0 to 0.1] vs. 2.0 mm2 [1.0 to 2.9] and median NIH volume 0.11 mm3 [0 to 2.1] vs. 35.3 mm3 [16.6 to 62.6]; both p < 0.0001). In the SES group, stent edges evidenced significant increase in lumen dimensions mainly due to significant increase in vessel volume, whereas those of the BMS group presented vessel shrinkage leading to significant lumen reduction. Late acquired incomplete stent apposition was observed in 11 lesions (14.7%) in the SES group and 0 in the BMS group (p = 0.001). At one year, no stent thromboses occurred in malapposed stents. CONCLUSIONS: The SES implantation effectively inhibits NIH in diabetic patients. The antirestenotic effect of SES is also appreciated at the stent edges. Late acquired stent malapposition is a frequent phenomenon in diabetic patients treated with SES.

Abstract: To find early clinical markers that may predict a likely progression to Alzheimer's disease (AD), the authors performed neuropsychological tests on 82 mild cognitive impairment (MCI) subjects. After 3 years, 38 patients developed AD while 44 retained the diagnosis of MCI. The cognitive differences between the groups were studied. Patients who developed AD showed significantly lower values than did MCI subjects in some neuropsychological scores (P = .02-.001), with sensitivities and specificities higher than 84% and 64%, respectively, for detecting early-onset AD, with a 7.9-fold increased risk of converting to AD (P < .001). Regarding the logistic regression model, the CAMCOG Memory and Perception cognitive screening items were the optimum independent tools to classify the patients who will progress to AD, showing a relative risk of progression of 10.5 (P = .002), 5.5 (P = .008), and 3.9 times (P = .05), respectively, with a sensibility of of 92.1% and a specificity 72.7%.

Abstract: BACKGROUND: The use of non-heart-beating donors could help shorten the list of patients who are waiting for a kidney transplant. Several reports describe acceptable results of transplantations from non-heart-beating donors who had in-hospital cardiac arrest, but few reports describe results of transplantations from non-heart-beating donors who had cardiac arrest that occurred outside of the hospital (Maastricht type I and type II donors). OBJECTIVE: To compare graft survival rates among patients receiving kidneys from heart-beating donors versus type I or type II non-heart-beating donors. DESIGN: Retrospective cohort study of transplantations performed from January 1989 to December 2004. SETTING: Kidney transplant program of a teaching hospital in Madrid, Spain. PATIENTS: 320 patients who received a kidney transplant from non-heart-beating donors (273 type I donors and 47 type II donors) and 584 patients who received a kidney transplant from heart-beating donors divided into 2 groups according to donor age (age <60 years [n = 458] and age > or =60 years [n = 126]). MEASUREMENTS: The primary outcome measure was graft survival. The median follow-up time was 68 months (range, 9 to 198 months). RESULTS: One- and 5-year graft survival rates were 90.7% and 85.5%, respectively, for transplants from heart-beating donors younger than 60 years of age; 79.8% and 73.3%, respectively, for transplants from heart-beating donors 60 years of age or older (P < 0.001); and 87.4% and 82.1%, respectively, for transplants from non-heart-beating donors (P = 0.22 [vs. those from heart-beating donors < 60 years of age] and P = 0.014 [vs. those from heart-beating donors >or = 60 years of age]). Graft survival did not differ between patients who received kidneys from heart-beating donors younger than 60 years of age and patients who received kidneys from non-heart-beating donors. LIMITATIONS: This single-site, observational study was retrospective, and immunosuppressive therapy regimens given to transplant recipients varied over time. CONCLUSIONS: Outcomes of transplants from non-heart-beating donors and younger heart-beating donors are similar, and results for transplants from non-heart-beating donors improved compared with those from older heart-beating donors. On the basis of these results, the authors encourage other transplant units to adopt the use of type I and type II non-heart-beating donors.

Abstract: INTRODUCTION AND OBJECTIVES. Diabetic patients frequently have small-diameter vessels, which increases their risk of restenosis. The aim of this study was to determine the efficacy of sirolimus-eluting stent implantation in these high-risk patients following percutaneous coronary intervention. METHODS. Our study population comprised a subset of 85 diabetic patients from the DIABETES (DIABETes and sirolimus Eluting Stent) trial who had very small vessels, defined as those with a reference diameter < or =2.25 mm. In the 100 lesions treated, 49 sirolimus-eluting stents and 51 bare-metal stents were used. Glycoprotein IIb/IIIa inhibitors were used as recommended by the protocol and dual antiplatelet therapy was administered for 1 year. RESULTS. Baseline clinical and angiographic characteristics were comparable in the two groups. The patients' mean age was 66 (9) years, 42% were women, and 37% were insulin-dependent. On average, the lesion length was 15.0 (9.0) mm and the reference diameter was 1.9 (0.2) mm. At 9-month follow-up, both late lumen loss and the restenosis rate were significantly lower in the sirolimus-eluting stent group than in the bare-metal stent group, at -0.03 (0.3) mm vs 0.44 (0.5) mm (P< .001), and 9.1% vs 39.1% (P=.001), respectively. These differences were also observed in the subgroup of insulin-dependent patients. At 1-year follow-up, the stent thrombosis rate was 0% in the sirolimus-eluting stent group, whereas two patients in the bare-metal stent group presented with stent thrombosis. CONCLUSIONS. Sirolimus-eluting stent implantation in diabetics with very small vessels is safe and effective, even in insulin-dependent patients.

Abstract: PURPOSE: One of the most relevant aspects in cell death regulation is the signalling of apoptosis by the serine/threonine kinases MAPKs. The aim of this study was to investigate the effects of TNF-alpha stimulation on MAPK activation, and the pro- or anti-apoptotic role of these kinases in LNCaP and PC3 cells. MATERIAL AND METHODS: Treatments were carried out using several TNF-alpha concentrations, as well as specific pharmacological inhibitors of MAPKs. Apoptosis rates were evaluated by DAPI staining and flow cytometry. MAPK phosphorylation/activation was measured by Western blot. RESULTS: TNF-alpha induced apoptosis in a dose-dependent manner in LNCaP but not in PC3 cells. The MAPK inhibitors revealed that the apoptotic rate in LNCaP cells increased significantly following p38 inhibition. The kinase inhibitors failed to cause changes in apoptosis in PC3 cells. CONCLUSIONS: The potentiation of apoptosis by p38 inhibition points to this kinase as a possible target for the treatment of androgen-dependent prostatic cancer.

Abstract: AIMS: To analyse the influence of lean pork (P) and veal (V) consumption on the lipid profile of healthy subjects within the framework of a healthy diet comprising low levels of total fat (TF), saturated fatty acids (SFA) and cholesterol. DESIGN: Double-crossover, randomized and controlled trial SUBJECTS: 44 healthy individuals (22 male and 22 female), recruited voluntarily from the University Complutense of Madrid. The weight and lipid profiles of these volunteers were normal and their dietary patterns were typical for people in our area. INTERVENTIONS: The study comprised 4 phases: stabilisation phase (5 weeks), the participants followed their normal diet; second phase (6 weeks), half of the subjects, were randomised to lean pork or veal consumption, 150 g per day, for their main meal of the day; washout period (5 weeks) and final phase, which was the second phase of intervention (6 weeks). During the intervention stages, only the main meal of the day was taken in the Hospital. The rest of the subjects' diets consisted of different fortnightly menus designed in accordance with the recommendations of the Spanish Society of Arteriosclerosis (SEA). RESULTS: After both stages of intervention had been completed, there was a mean reduction of 5.5% in low-density lipoprotein cholesterol. However, after each intervention there were no significant differences between those who had consumed P, 2.62 (0.55) mmol/L and those who had consumed V, 2.71 (0.47) mmol/L. No differences were observed in any of the other parameters between those who had consumed P and those who had consumed V. CONCLUSIONS: Lean pork and veal produces similar effects on the lipid profiles of healthy subjects. Its consumption, as part of the saturated fat and cholesterol-controlled diet, could therefore be included in food guidelines, both for normal and therapeutic diets.

Abstract: BACKGROUND: The implications of the American College of Cardiology/American Heart Association (ACC/AHA) lesion classification in patients with in-stent restenosis (ISR) are unknown. METHODS: Four hundred fifty patients included in the RIBS randomized study were analyzed. A centralized core laboratory assessed ISR classifications including ACC/AHA, the classification of Mehran et al (Circulation 1999;100:1872-8), diffuse/focal, and a new quantitative ISR index (lesion length/stent length). Logistic regression models were constructed for prespecified outcome measures including (1) unsatisfactory acute results and (2) recurrent restenosis rate. RESULTS: Complex (B2/C) lesions (78%) more frequently obtained unsatisfactory acute results (20% vs 8%, P = .007), smaller minimal lumen diameter after the procedure (2.45 +/- 0.5 vs 2.73 +/- 0.5 mm, P = .001) and at follow-up (1.48 +/- 0.8 vs 1.94 +/- 0.8 mm, P = .0001), and had a higher restenosis rate (43 vs 24%, P = .001) than simple (A/B1) lesions. On logistic regression analysis, all classification schemes were useful to predict unsatisfactory initial results (area under the curve: 0.63, 0.61, 0.59, and 0.62) and recurrent restenosis (area under the curve: 0.60, 0.64, 0.61, and 0.63). The predictive ability of these schemes persisted despite adjustment for potential confounders. Although the ACC/AHA classification was a better predictor of acute results, the classification of Mehran was superior to predict restenosis. CONCLUSIONS: The ACC/AHA classification provides a useful tool to determine acute procedural results and the long-term angiographic outcome of patients with ISR.

Abstract: The aim was to determine whether semi-quantitative procalcitonin (PCT-Q) measurements on admission can identify the severity of meningococcal infection in children. A total of 65 children (mean age 2.4 years) with meningococcal disease were included in a prospective study. All patients were treated with antibiotics, rehydration, inotropic drugs and mechanical ventilation if presenting with shock or respiratory failure. On admission, blood was drawn for routine laboratory analyses including absolute neutrophil count (NC), C-reactive protein (CRP) and PCT-Q (immunochromatographic test). A total of 33 patients presented with septic shock on admission of whom 18 developed multiple organ dysfunction syndrome (MODS) and 9 died. Forty-three patients showed a very high PCT-Q level (>or=10 ng/ml), 12 showed values between 2-9.9 ng/ml and the remaining 10 patients showed PCT-Q levels<2 ng/ml. All patients with a PCT-Q level<10 ng/ml survived, whereas all those who developed MODS or died had PCT-Q levels>or=10 ng/ml. Receiver operator curve analysis showed that PCT-Q and NC had a high predictive value for MODS and death. PCT-Q showed a sensitivity of 100%, a negative predictive value of 100% and a negative likelihood ratio of 0.0 for MODS and death. CONCLUSION: semi-quantitative procalcitonin levels under 10 ng/ml predict good outcome of children with meningococcal infection. It is a highly sensitive method to identify patients with an increased risk of multiple organ dysfunction syndrome or death.

Abstract: BACKGROUND AND OBJECTIVES: Epidemiological data on the incidence and prevalence of cardiovascular disease in chronic renal failure are scant The objective of the present study is to assess the relationship between renal function, measured by the estimated glomerular filtration rate, and the presence of early or established cardiovascular disease, in a population of hypertensives from primary care. PATIENTS AND METHODS: Cross-sectional, multicentre study carried out in primary care centres all over Spain. Hypertensive subjects, older than 55 years, were included. In all of them a structured interview including cardiovascular risk factors or disease was performed. Blood pressure was measured following a standard procedure, and serum biochemistry and an electrocardiogram were obtained. Renal function was estimated using the abbreviated MDRD (Modification of Diet in Renal Disease Study Group) equation. For each glomerular filtration rate stratum the odds ratio and 95% confidence interval (CI) of left ventricular hypertrophy or cardiovascular disease were calculated, adjusted by confounding variables. RESULTS: A total of 13 687 patients (mean age 68.1 years, women 55.4%, diabetics 30.6%, body mass index 28.6 kg/m2) were included. Of these, 26.4% had established cardiovascular diseases and 20.3% electrocardiographic left ventricular hypertrophy. The average serum creatinine was 1.01 mg/dl, creatinine clearance 70.0 ml/min, and glomerular filtration rate 74.0 ml/min per 1.73 m2. Thirty-three patients (0.24%) had glomerular filtration rate < 5 ml/min per 1.73 m2; 89 (0.65%) from 15 to 29; 3745 (27.36%) from 30 to 59; 7798 (56.97%) from 60 to 89; and 2019 (14.75%) higher than 89 ml/min per 1.73 m2. In a multiple regression analysis, after adjusting by age, sex, body mass index, diabetes, systolic and diastolic blood pressure, and smoking, a lower glomerular filtration rate was associated with a higher prevalence of left ventricular hypertrophy. Likewise, a reduction in the glomerular filtration rate was also associated with a higher prevalence of cardiovascular disease. CONCLUSIONS: In hypertensive patients from primary care, the prevalence of cardiovascular disease is inversely proportional to the level of renal function. Estimated glomerular filtration is easy to determine and complements evaluation of the hypertensive patient.

Abstract: AIMS: The randomized NASPEAF study included non-valvular with prior embolism and mitral stenosis patients in the same group. This is a sub-study to specially focus on the antithrombotic therapy in mitral stenosis. METHODS AND RESULTS: We analysed 311 patients with mitral stenosis, compared with 175 non-valvular atrial fibrillation patients with prior embolism, stratified by a history of previous embolism and assigned to anticoagulant therapy [target international normalized ratio (INR) = 2.0-3.0] or combined antiplatelet plus moderate intensity anticoagulant therapy. Median follow-up was 2.9 years. Outcomes were fatal and non-fatal embolism, stroke and myocardial infarction, sudden death, and death from bleeding. Combined therapy in mitral stenosis patients, compared with anticoagulant alone therapy, reduced the risk of vascular events by 58.3%. During equal therapy, the outcome annual rates were essentially the same in non-valvular and valvular patients [hazard ratio 0.90 (95% confidence interval 0.37-2.16), P = 0.81]. During anticoagulant alone therapy, the annual event rate in mitral stenosis patients without prior embolism was low (2.5%) and it was very high in patients with prior embolism (6.6%). CONCLUSION: Combined therapy was effective in mitral stenosis patients. Prior embolism patients are not efficiently protected with anticoagulant alone therapy for an INR of 2.0-3.0.

Abstract: European guidelines indicate the importance of the evaluation of global cardiovascular risk (CVR) to determine the management of the hypertensive patients (EH). However, in primary care, the diagnostic work-up (PCD) only includes the metabolic risk factors. The aim of this study was to assess the importance of microalbuminuria (MA) and echocardiogram (ECHO) in the process of risk stratification, and the number of patients to be treated with drugs at diagnosis. In total, 155 nontreated EH were included in the study. Blood pressure, a lipid profile and plasma glucose (LG) were determined after an overnight fast. MA was evaluated with dipstick MICRALTEST, and in those patients with two positive results, it was measured again in two 24-h urine samples and was considered positive (MA+) if the average was >30 mg/24 h. Left ventricular mass index was calculated and values>125 g/m2 were considered as LV hypertrophy (LVH+). When the patients were stratified according to PCD, 22 had to be treated with drugs. When MA, ECHO and both tests used together were added to the risk evaluation, the number of patients to be treated were 42, 51 and 64, respectively (P<0.001 vs PCD). It is mainly in patients who have moderate cardiovascular risk that risk changes, whereas risk hardly changes in those having low and very high risk. In conclusion, in EH with moderate risk, measurement of MA, due to its easy availability and low cost, seems to be a cost effective screening test to avoid the underestimation of the CVR.

Abstract: BACKGROUND: As the main mineral reservoir, bone acts as a calcium (Ca) and phosphate buffering system. Accordingly, phosphate removal by haemodialysis (HD) might be theoretically influenced by bone turnover, as well as by the interaction of regulatory molecules, such as PTH and osteoprotegerin (OPG). The present study investigated the relationship between these variables and phosphate removal by HD. METHODS: Blood samples for serum Ca, phosphate, bicarbonate, intact PTH, PTH (1-84), bone alkaline phosphatase, tartrate-resistant acid phosphatase 5b, OPG and receptor activator of nuclear factor-kappaB ligand (RANKL) were obtained in 28 HD patients. Phosphate removal was measured by a continuous collection of the dialysate. RESULTS: Pre-dialysis serum phosphate concentration is the critical factor in determining dialytic phosphate removal. However, multiple regression analysis reveals that phosphate removal is better explained by a combination of factors than by phosphate concentration alone. In this model, the PTH/OPG ratio is an additional positive factor, whereas age and vitamin D treatment are negative factors. Patients with pre-HD bicarbonate higher than 20 mEq/l had higher serum phosphate and, accordingly, higher phosphate removal; of interest, these individuals also have significant differences in RANKL/OPG. Mean (SD) OPG levels were significantly higher than that in the healthy population (16.2 (12.5) pmol/l; these values correlated with age (r = 0.4, P<0.04). Mean serum RANKL (1.03 (1.02) pmol/l) was within the range of normal individuals. CONCLUSIONS: Dialytic phosphate removal has a crucial, direct relationship with pre-HD plasma phosphate levels. However, the phenomenon of phosphate removal is more precisely explained using a more complex relationship, defined by the interaction between serum phosphate, PTH/OPG, age and vitamin D administration. Serum RANKL levels are first reported in HD patients, and are not different from the normal population.

Abstract: BACKGROUND AND OBJECTIVES: The aim of this study was to evaluate the incidence and severity of chemotherapy-induced nausea and vomiting (CINV) in oncohematology in routine clinical practice, its impact on quality of life, and caregivers' perception of the extent of the problem. DESIGN AND METHODS: This was a multicenter, prospective, observational follow-up study including: (i) acute myeloid leukemia patients treated with moderately to highly emetogenic chemotherapy and (ii) hematopoietic stem cell transplant recipients, without reduced intensity conditioning. No exclusion criteria were applied. All patients received at least one 5-HT3 antagonist for emesis prophylaxis. Patients recorded emetic episodes and rated nausea daily. Quality of life was assessed through a validated functional living Index-Emesis questionnaire. A survey of caregivers' predictions of CINV was made and the predictions then compared with the observed CINV. RESULTS: One hundred consecutive transplant and 77 acute myeloid leukemia patients were studied. Transplant conditioning was the most important risk factor for CINV: complete response occurred in only 20% of transplant patients (vs. 47% for leukemia patients). Among patients with emesis, the mean percentage of days with emesis and the mean (+/-SD) total number of emetic episodes were 61% and 9.4+/-8.9 (transplant recipients), and 53.6% and 6.2+/-7.3 (leukemia patients), respectively. CINV control was lower in the delayed than in the acute phase. Antiemetic rescue therapy was ineffective. CINV had a deleterious effect on quality of life, especially among transplant recipients. Caregivers underestimated the incidence of delayed nausea and emesis in the transplant setting. INTERPRETATION AND CONCLUSIONS: Despite 5-HT3 antagonist prophylaxis, CINV remains a significant problem in oncohematology, especially in the delayed phase and in transplant recipients.

Abstract: INTRODUCTION AND OBJECTIVES: Left ventricular hypertrophy (LVH) is the earliest manifestation of cardiac damage in hypertension. Its appearance is associated with a poor cardiovascular prognosis. The objectives of this study were to determine the prevalence of electrocardiographic LVH and to assess the epidemiological characteristics of hypertensive patients receiving primary care. PATIENTS AND METHOD: A cross-sectional multicenter study of hypertensive patients aged 55 years or more was carried out in a primary care setting. Blood pressure was measured using the standard method. Cardiovascular history was determined from medical records and LVH was assessed electrocardiographically using Cornell's criteria. RESULTS: In total, 15 798 patients (mean age 68.0 years, 55.3% women, and 30.4% with diabetes mellitus) were evaluated. Of these, 3207 (20.3%) had electrocardiographic signs of LVH. The prevalence was higher in males, diabetics, smokers, and patients with high blood pressure or renal or cardiovascular disease. Compared to patients without LVH, those with the condition were older, were more often male, and were more likely to have diabetes or renal or cardiovascular disease. Multivariate analysis showed that LVH was independently associated with advanced age, male gender, diabetes, smoking, poor blood pressure control, and the presence of cardiovascular or renal disease. Blood pressure control was poorer in patients with LVH than in those without it. CONCLUSIONS: The prevalence of electrocardiographic LVH is high, with affected patients being more likely to have diabetes or renal or cardiovascular disease. Moreover, blood pressure control is poor in these patients, and more aggressive pharmacological management is needed.

Abstract: OBJECTIVES: We compared the risk of stent thrombosis (ST) after drug-eluting stents (DES) versus bare-metal stents (BMS), and tested the hypothesis that the risk of DES thrombosis is related to stent length. BACKGROUND: Whether DES increase the risk of ST remains unclear. Given the very low restenosis rate after drug-eluting stenting, longer stents are frequently implanted for the same lesion length in comparison to BMS. METHODS: We included in a meta-analysis 10 randomized studies comparing DES and BMS. Overall, 5,030 patients were included (2,602 were allocated to DES and 2,428 to BMS). The risk of thrombosis after DES versus BMS was compared, and the relationship between the rate of DES thrombosis and stent length was evaluated. RESULTS: Incidence of ST was not increased in patients receiving DES (0.58% vs. 0.54% for BMS; odds ratio: 1.05; 95% confidence interval [CI]: 0.51 to 2.15; p = 1.000). The overall rate of ST did not differ significantly between patients receiving sirolimus- or paclitaxel-eluting stents (0.57% vs. 0.58%; p = 1.000). We found a significant relation between the rate of ST and the stented length (Y = -1.455 + 0.121 X; 95% CI for beta: 0.014 to 0.227; R = 0.716; p = 0.031). In patients with DES, mean stented length was longer in those suffering ST (23.4 +/- 8.1 mm vs. 21.3 +/- 4.1 mm, p = 0.025). CONCLUSIONS: Drug-eluting stents do not increase the risk of ST, at least under appropriate anti-platelet therapy. The risk of ST after DES implantation is related to stent length.

Abstract: A trend toward a higher incidence of hepatocelullar carcinoma (HCC) in patients with cirrhosis treated with bare-stent transjugular intrahepatic portosystemic shunt (TIPS) has been observed in previous studies. To assess the influence of TIPS as a risk factor for developing HCC, we have compared the incidence of HCC in two retrospective cohorts of patients. The TIPS cohort (n = 138) included patients with cirrhosis who underwent TIPS placement for the treatment of portal hypertension-related complications; the non-TIPS cohort was composed of patients admitted at the hospital at the same time of TIPS insertion who were individually matched 1:1 according to age, sex, Child-Turcotte-Pugh class, and cause of cirrhosis. A stratified Cox model was used to assess risk of HCC development. The median time of follow-up was similar in TIPS and non-TIPS cohorts (30.3 [range, 7.8-119.5] and 31.4 [range, 7.8-110.8] months, respectively). The cumulative probability of developing HCC at 1, 3, and 5 years was 3%, 24%, and 34% for the TIPS cohort and 1%, 6%, and 25%, for the non-TIPS cohort, respectively (Breslow test = 5.23, P = .022). The adjusted hazard ratio was 1.52 (95% confidence interval, 1.06-2.19; P = .02). Hepatitis C virus infection and age were independent predictors of HCC development in patients without TIPS. In conclusion, patients with cirrhosis who are treated with TIPS may have a higher incidence of HCC. This observation suggests the need for a strict HCC surveillance program for these patients, especially if they are not expected to undergo a short- or medium-term liver transplantation.

Abstract: BACKGROUND AND OBJECTIVE: Two different pathways for the development of tumor have been described in colorectal carcinoma: the chromosomic instability, raised by suppressor genes and proto-oncogene alterations, and the microsatellite instability (MSI), caused by alterations in DNA repairing genes. PATIENTS AND METHOD: The frequency and the clinical meaning of the microsatellites instability pathway were determined in a consecutive prospective cohort of 106 patients who underwent surgical resection of colorectal carcinoma by a single surgeon. Microsatellite instability determination was established according to the criteria proposed by the National Cancer Institute in 1998. RESULTS: 9.4% of patients had a high instability and it was low in 11.3%; both groups displayed different clinico-pathological characteristics (age, sex, tumor site and histologic type). In the multivariant analysis of overall survival and disease free survival, high instability exhibited prognostic value independent of the rest of variables evaluated (p < 0.0001). CONCLUSIONS: The genetic alterations giving rise to microsatellite instability lead to a better prognosis in patients with colorectal cancer.

Abstract: AIMS: To investigate the relationship between coronary artery remodelling and glycaemic and lipid profiles in diabetic patients. METHODS AND RESULTS: Intravascular ultrasound analyses of 131 angiographically non-significant coronary stenoses in 80 diabetic patients were performed. The remodelling index (RI) was calculated as the ratio between total vessel area at target site and total vessel area at proximal reference, and was assessed in two ways: as a continuous variable, and as a binary categorical variable: RI<1 namely, negative remodelling (group I), or RI> or =1 (group II). Percentage cross-sectional narrowing was 57+/-13%. On average, RI was 0.93+/-0.13. Coronary shrinkage was found in 94 (71.7%) lesions. Significant inverse correlations were demonstrated between RI and total cholesterol (r=-0.26, P=0.003), apolipoprotein-B (r=-0.23, P=0.01) and LDL-cholesterol (r=-0.3, P=0.001) levels. Multivariable lineal regression analysis identified LDL-cholesterol as the only independent predictor of RI (P=0.001). CONCLUSION: Negative remodelling is a frequent finding in diabetics and it is associated with LDL-cholesterol levels. This may contribute to the diffuse coronary artery disease observed in diabetic patients.

Abstract: PURPOSE: To evaluate the efficacy of two artificial tears for the treatment of dry eyes: 0.15% sodium hyaluronate and polyvinyl alcohol. METHODS: The study included 60 dry eyes in 30 patients. Fifteen of the patients were treated with 0.15% sodium hyaluronate and 15 with polyvinyl alcohol. Five drops a day for one month was given in both groups. Visual acuity, Schirmer's test, tear clearance, dry eye symptoms questionnaire, fluorescein and rose bengal staining, corneal sensibility, bulbar hyperemia, tear detritus, meibomian gland plug, palpebral erythema and edema before and after treatment were evaluated. RESULTS: Symptoms as judged by the dry eye questionnaire, as well as both fluorescein and rose bengal staining, were significantly improved by 0.15% sodium hyaluronate. The polyvinyl alcohol treated patients did not show a significant improvement in any parameter. CONCLUSION: Sodium hyaluronate was more effective than polyvinyl alcohol in the treatment of patients with dry eyes (Arch Soc Esp Oftalmol 2005; 80: 387-394).

Abstract: BACKGROUND: Outcomes after percutaneous coronary interventions in diabetic patients are shadowed by the increased rate of recurrence compared with nondiabetic patients. METHODS AND RESULTS: We conducted a multicenter, randomized trial to demonstrate the efficacy of sirolimus-eluting stents compared with standard stents to prevent restenosis in diabetic patients with de novo lesions in native coronary arteries. The primary end point of the trial was in-segment late lumen loss as assessed by quantitative coronary angiography at 9-month follow-up. The trial was stratified by diabetes treatment status. One hundred sixty patients were randomized to sirolimus-eluting stents (80 patients; 111 lesions) or standard stent implantation (80 patients; 110 lesions). On average, reference diameter was 2.34+/-0.6 mm, lesion length was 15.0+/-8 mm, and 13.1% of lesions were chronic total occlusions. In-segment late lumen loss was reduced from 0.47+/-0.5 mm for standard stents to 0.06+/-0.4 mm for sirolimus stents (P<0.001). Target-lesion revascularization and major adverse cardiac event rates were significantly lower in the sirolimus group (31.3% versus 7.3% and 36.3% versus 11.3%, respectively; both P<0.001). Non-insulin- and insulin-requiring patients demonstrated similar reductions in angiographic and clinical parameters of restenosis after sirolimus-eluting stent implantation. During the 9-month follow-up, stent thrombosis occurred in 2 patients after standard stent implantation. Conversely, this phenomenon was not seen in the sirolimus stent group. CONCLUSIONS: This randomized trial demonstrated that sirolimus stent implantation is safe and efficacious in reducing both angiographic and clinical parameters of restenosis compared with standard stents in diabetic patients with de novo coronary stenoses.

Abstract: OBJECTIVES: We sought to analyze the very late outcomes of patients treated for in-stent restenosis (ISR) according to treatment allocation and 10 prespecified variables. BACKGROUND: Long-term results (>2 years) of patients with ISR undergoing repeat coronary interventions are not well established. METHODS: The Restenosis Intrastent: Balloon angioplasty versus elective Stenting (RIBS) randomized study compared these two strategies in 450 patients with ISR. A detailed systematic protocol was used for late clinical follow-up. RESULTS: At one-year follow-up (100% of patients), the event-free survival was similar in the two groups (77% stent implantation [ST] arm, 71% balloon angioplasty [BA] arm, log-rank p = 0.19). Additional long-term clinical follow-up (median 4.3 years, range 3 to 5 years) was obtained in 98.6% of patients. During this time 22 additional patients died (9 ST arm, 13 BA arm), 7 suffered a myocardial infarction (3 ST arm, 4 BA arm), 23 required coronary surgery (11 ST arm, 12 BA arm), and 9 underwent repeat coronary interventions (4 ST arm, 5 BA arm) (nonexclusive events). At four years the event-free survival was 69% in the ST arm and 64% in the BA arm (log-rank p = 0.21). Among the 10 prespecified variables, vessel size > or = 3 mm had a major influence on the clinical outcome at four years, with better results in the ST group (hazard ratio 0.51, 95% confidence interval 0.3 to 0.89, p = 0.016). CONCLUSIONS: Patients with ISR undergoing repeat interventions have a significant event rate at late follow-up. Continued medical surveillance should be continued after one year. Patients with large vessels have a better outcome after repeat stenting.

Abstract: AIM: Recurrent ovarian cancer is a major problem and an accurate diagnosis can often change patients' management. This study aimed to assess the impact on management of FDG-PET in recurrent ovarian cancer. MATERIAL AND METHODS: Forty-three patients in whom FDG-PET scan was performed due to suspected recurrent ovarian cancer were included. FDG-PET results were confirmed by histopathology and clinical follow-up of at least 12 months. To assess impact on management the treatment plan based on conventional imaging methods was compared with the treatment plan based on inclusion of PET findings, classifying FDG-PET impact on management as high, medium, low or no impact. Management changes, when present, were classified as intermodality or intramodality. RESULTS: FDG-PET had a high impact on therapeutic management in 28 patients (65.1 %), medium impact in 2 patients (4.6 %), low impact in 9 patients (20.9 %), and no impact in 4 patients (9.3 %). FDG-PET induced an intermodality change in management in 27 patients (62,8 %); intramodality changes were induced in 3 patients (7 %). Finally, it produced no treatment changes in 13 patients (30.2 %). CONCLUSION: FDG-PET supplied additional information when compared to conventional diagnostic procedures and allowed adequate management changes in most patients.

Abstract: OBJECTIVE: To establish the prevalence of diabetic retinopathy (DR), types and risk factors in a diabetic population in Extremadura. METHODS: A cross-sectional study, with prospective data collection, was performed between 1997 and 2001 on 3,114 randomly selected diabetic patients belonging to 13 Diabetologic Assistance Centers. We evaluated: age, gender, type, treatment, duration of diabetes and blood pressure levels. Two color fundus photographs were taken and ophthalmoscopy was performed on both eyes. Data were analyzed using SPSS (11.5). RESULTS: The mean age of the patients was 63.8 (SD13.4) years, 7.5% were type 1 diabetics, 31.1% were insulin-treated and 46.0% had elevated blood pressure. Prevalence of DR was 35.7%, macular edema: 5.6% and proliferative DR: 5.3%. Multivariate analysis showed that type 1 diabetics have a DR frequency 1.79 times higher than type 2 diabetics (ORaj 1.79; IC 95% 1.22-2.63; p=0.003). Patients who have been diabetic for 5-10 years have a frequency 2 times higher (ORaj 2.00; IC 95% 1.62-2.45; p<0.001), patients diabetic for more than 15 years have a frequency 5.48 times higher (ORaj 5.48; IC 95% 4.33-6.93; p<0.001) than patients who have been diabetic for less than 5 years. The frequency of DR in patients aged more than 60 years is 23% higher than those under that age. (ORaj 1.23; IC 95% 1.01-1.50; p=0.045). CONCLUSIONS: 37.5% of the diabetic population in Extremadura is affected by diabetic retinopathy. New analyses are necessary in this population to detect the existence of other high risk subgroups in order to reduce these high prevalence levels.

Abstract: OBJECTIVE: Patients undergoing heart surgery show a high risk of catheter colonization and catheter-related bloodstream infections. We evaluated whether skin insertion site and catheter hub surveillance cultures ("surface cultures") could predict catheter colonization and help establish the origin of bloodstream infections. DESIGN:: Prospective cohort study. SETTING: An 11-bed heart surgery intensive care unit in a tertiary university hospital. PATIENTS: Heart surgery patients spending >4 days in intensive care over an 11-month period. INTERVENTIONS: All catheters were surveyed. Cultures were obtained from the skin insertion site and all hubs on day 5 after surgery, every 72 hrs thereafter, and on catheter removal. Swabs were processed semiquantitatively by streaking the surface of a Columbia agar plate. Catheters were processed using Maki's method. The observation of > or = 15 colonies/plate was taken to indicate a positive skin or catheter colonization culture result. MEASUREMENTS AND MAIN RESULTS: Over the study period, 561 catheters were inserted in 130 patients. The median time a catheter was in place was 6 days (interquartile range 3-11), and 3,712 surface cultures were obtained (median four per patient). Catheter colonization occurred in 133 catheters, and there were 15 episodes of catheter-related bloodstream infection (incidence density of colonization 29.3 and of catheter-related bloodstream infection 8.8 per 1,000 catheter-days). Validity indexes for the capacity of surface cultures to predict catheter colonization and catheter-related bloodstream infection, respectively, were as follows: accuracy, 71.4, 65.6; sensitivity, 83.5%, 100%; specificity, 67.1%, 64.7%; positive predictive value, 47.6%, 7.2%; negative predictive value, 91.9%, 100%; positive likelihood ratio, 2.5, 2.83; and negative likelihood ratio, 0.2, 0. Surface cultures correctly predicted 77.4% of all bacteremia episodes (catheter-related and non-catheter-related). CONCLUSIONS: Systematic surveillance cultures of catheter hub and skin insertion sites in patients admitted to a heart surgery intensive care unit could help identify patients who would benefit from decontamination and preventive measures and establish whether catheters are the portal of entry of bloodstream infection.

Abstract: The concurrent use of erythropoietin beta (EPO)and radiotherapy in head and neck cancer patients has been reported by Henke et al (Lancet 2003;362:1255-60) to correct anemia and impair cancer control. Due to the potential impact in daily clinical practice of this information a systematic critical review of the mentioned article was performed. Authors selected 10 arguments to question the contents regarding methodological and statistical aspects of the trial, and added 14 comments of controversy in more basic scientific concepts mentioned in the text as published. The panel including epidemiologist and radiation oncologists with expertise in clinical research concluded with 5 additional remarks recommending caution in interpretation of these results in terms of changes in daily practice of anemic patients support, and advising not to use EPO at experimental doses or after reaching physiological concentrations of hemoglobin.

Abstract: BACKGROUND AND OBJECTIVE: Stroke is a major cause of morbidity and mortality in hypertensive population. The aim of this study is to estimate the 10-year risk of a first stroke in Spanish hypertensive population using the Framingham scale. PATIENTS AND METHOD: Cross-sectional multicenter study in primary care environment, on hypertensive patients aged 55 or more (10 consecutive patients each physician). Blood pressure (BP) was measured according to standardized rules. Stroke and coronary risk were estimated using the Framingham scale. RESULTS: 16,129 patients (mean age 67.7 years; 57.1% women; 30.4% with diabetes mellitus; 26.6% with previous history of cardiovascular disease) were analyzed. 20.3% showed electrocardiographic left ventricular hypertrophy (more prevalent in males, diabetics, with systolic BP > or = 140 mmHg; p < 0.001). The goal of BP control was reached in 30.1% of non-diabetic patients and only in 5.9% of diabetics. The estimated 10-year risk of a first stroke (standard deviation) was estimated to be 19.9% (16.8), and the coronary risk 19.2% (14.0). While males had an estimated risk of coronary disease above the stroke risk, women had an estimated risk of a first stroke greater than the estimated risk of coronary disease. CONCLUSIONS: The estimated risk of stroke among Spanish hypertensive population is high, and the main risk factors (age, systolic BP, diabetes and left ventricular hypertrophy) tend to aggregate. In women estimated risk of stroke in greater than estimated coronary risk. The risk of stroke must be taken into account in the assessment and treatment of hypertensive patients.

Abstract: Adiponectin is a plasma protein produced by the adipose tissue. Hypoadiponectinemia has been associated with insulin resistance and several components of the metabolic syndrome (MS): type 2 diabetes, obesity, and dyslipidemia. We investigated whether single nucleotide polymorphisms (SNPs) at positions 45 and 276 in the adiponectin gene were associated with features of the MS in 747 unrelated Spanish subjects. The G allele of SNP45 and the G/G genotype of SNP276 were associated with impaired glucose tolerance (p = 0.020 and 0.042, respectively). The G/G genotype for SNP276 was associated with lower serum adiponectin levels as compared with the G/T and T/T genotypes (G/G, 10.10 +/- 0.24 microg/mL; G/T, 10.98 +/- 0.32 microg/mL; T/T, 12.00 +/- 0.92 microg/mL; p = 0.015) even after adjustment for sex, age, BMI, waist-to-hip ratio, homeostasis model assessment index, and the degree of glucose tolerance (p = 0.040). We found a significant negative association of circulating adiponectin levels with waist-to-hip ratio (r = -0.42, p < 0.001), sagittal abdominal diameter (r = -0.24, p < 0.001), triglycerides (r = -0.32, p < 0.001), homeostasis model assessment index (r = -0.14, p = 0.001), and uric acid (r = -0.36, p < 0.001) and positive association with high-density lipoprotein-cholesterol (r = 0.41, p < 0.001). Our findings indicate that serum adiponectin levels are associated with several components of the MS. The SNP276 of the adiponectin gene may affect impaired glucose tolerance and hypoadiponectinemia.

Abstract: AIM: The aim of this paper was to perform a meta-analysis of the literature to evaluate the accuracy of FDG-PET in recurrence detection in patients with ovarian cancer. METHODS: The search strategy consisted in identifying papers published between November 1972 and October 2003 indexed in MEDLINE and CANCERLITE. Inclusion criteria were publications that evaluated recurrence with FDG-PET in patients with ovarian carcinoma. Exclusion criteria were duplicated papers or those outdated by subsequent ones. The statistical analysis included 95 % confidence intervals (CI) of sensitivity (S), specificity (Sp) and natural logarithm of the odds ratio (Ln OR). RESULTS: Seventeen publications fulfilled the inclusion criteria and were analyzed. The S and Sp were 0.94 (95% CI, 0.93-0.96) and 0.65 (95% CI, 0.46-0.85), respectively. The Ln OR presented global homogeneity and significant values in > 75% of the studies. CONCLUSION: According to our meta-analysis, FDG-PET has high S and intermediate Sp, with few false negative results. These preliminary findings suggest that FDG-PET may be an effective means of identifying patients with recurrent ovarian cancer.

Abstract: BACKGROUND AND OBJECTIVE: We aimed to estimate the prevalence of the Metabolic Syndrome (MS) in rural and urban areas of the Province of Segovia, Spain, according to the ATPIII criteria (National Cholesterol Education Program's Adults Treatment Panel III report) modified. SUBJECTS AND METHOD: Cross-sectional design. Randomized and representative sample of 809 individuals (46% males) aged 35-74 years. Residents in urban and rural areas of the Province of Segovia (Spain). Period of study from January 2000 to January 2003. RESULTS: The age/sex standardized prevalence of the MS was 17%; 15.7% in males and 18.1% in females. No significant differences in MS prevalence between rural and urban areas were found. The most frequent combination of individual components of MS was abdominal obesity, hyperglycemia and arterial hypertension in males and females. MS was associated with age and obesity in an adjusted logistic regression model. In a second model, abdominal obesity was more common in those individuals with a BMI over 30 kg/m2, secondary education level, age over 45 years, and in female residents in rural areas. CONCLUSIONS: The sex/age adjusted prevalence was lower than that reported in other studies using the ATPIII criteria in Spain. Abdominal obesity was the most frequent single component of MS in females whereas it was arterial hypertension in males.

Abstract: INTRODUCTION AND OBJECTIVES: Recent clinical studies suggest a potential antiarrhythmic role of angiotensin-converting enzyme inhibitors in preventing atrial fibrillation. Studies in an animal model suggested that these drugs may prevent sustained atrial fibrillation by avoiding the occurrence of detrimental atrial electrical remodeling secondary to temporary episodes of fibrillation or atrial tachycardia. We sought to determine whether intravenous enalaprilat, administered at doses habitually used in clinical practice, prevented pacing-induced acute atrial remodeling. PATIENTS AND METHOD: We analyzed 16 patients with no structural heart disease referred for electrophysiologic study due to supraventricular tachycardia. During the control period, right and left atrial effective refractory periods (ERP) were determined before and after a 10-minute period of rapid atrial pacing (250 ms) to quantitatively assess pacing-induced shortening of the ERP. After full recovery, a bolus dose of enalaprilat (0.015 mg/kg) was infused and the measurement and stimulation procedure repeated to quantify remodeling after enalaprilat administration. RESULTS: In the control period, rapid pacing induced a significant 14% reduction (P<.01) in right atrial ERP and an 8% decrease (P<.01) in left atrial ERP as compared to baseline values. In the enalaprilat period, rapid pacing significantly reduced ERP by 15% in the right chamber (P<.01) and 7% in the left chamber (P<.01). There was no significant difference in the extent or time course of ERP shortening between the control and enalaprilat periods. The number of unintentionally induced atrial fibrillation episodes did not differ significantly between the two periods. CONCLUSIONS: Intravenous enalapril does not avoid the occurrence of pacing-induced acute electrical atrial remodeling, modify its time course, or impede the induction of atrial fibrillation.

Abstract: OBJECTIVES: To perform a systematic review on the expression and prognostic value of the p 53 oncoprotein and Ki 67 proliferation marker in transitional cell carcinoma of the upper urinary tract. METHODS: A systematic review of cohort, prospective and retrospective studies from 1/1/1990 to 11/24/2003 has been undertaken, performing a bibliographic search both manual and electronic in the main databases. 632 works were found using the keywords "ureter, renal and pelvis tumor", and 14 with "ureter, renal and pelvis tumor, and immunohistochemical". RESULTS: 509 patients were studied; they were selected from 7 retrospective studies about the usefulness of p53 and Ki 67 in transitional cell carcinoma of the upper urinary tract published between 1995 and 2002 (three Spanish studies, three Japanese and one North American). Each one analyzes between 37 and 121 cases, with a mean age of 66.8 years (range 63.0-74.7) and a predominance of male sex in 100% of the studies. The pyelocalyceal site was the most frequent in these series. Treatment is another issue taken into consideration in this papers, being nephroureterectomy the most frequently found. The p53 and Ki 67 percentage expression in various studies has been related to clinical and histological factors. Only 5 studies performed a multivariate analysis using Cox regression models. Three of them deal with Ki 67 and two with p53, although one of the p53 studies associates cyclin E determinations. Only two out of three studies about Ki 67 were considered evaluable, because multivariate analysis was not performed in the other one. CONCLUSIONS: 1) There are a few studies and they are very heterogeneous in terms of design, selection criteria, follow-up, and use of prognostic variables. 2) The analyzed studies establish that oncoprotein p53 and proliferation marker Ki 67 are prognostic factors for transitional cell carcinoma of the upper urinary tract, and 3) To perform a meta-analysis was deemed not indicated because of the heterogeneicity of the studies found in our search.

Abstract:

Abstract: BACKGROUND: Acute otitis media (AOM) is a serious public health problem and is considered one of the most common diagnoses in pediatric outpatient units. The aim of this study was to asses the incidence and distribution of AOM by age, sex, number of visits per episode, and the most frequent symptoms and signs in four pediatric primary care units. PATIENTS AND METHODS: A 12-month (1 September 2000 to 31 August 2001), prospective study was carried out in a primary care center on the outskirts of Madrid. RESULTS: During the study period there were 1,098 consultations for AOM in 521 patients. The overall incidence per 100,000 children aged less than 14 years was 12,080 cases (95 % CI: 11,120-13,090). The highest incidence per 100,000 children was in children aged 12-23 months with 38,780 cases (95 % CI: 33,340-44,430). A total of 34.5 % of the children diagnosed with AOM were aged less than 2 years. Ninety-six percent of the children received antibiotics. Most (81.4 %) of the children were completely cured while symptoms persisted in 15.4 %. A minority of the children (3.5 %) were referred to the otolaryngology department.

Abstract: To determine whether there are variations in leptin levels according to the beta(3)-adrenoceptor (beta(3)-AR) Trp64Arg and uncoupling protein 1 (UCP1) -3826A-->G polymorphisms, given the regulatory role of catecholamines through the beta(3)-AR in leptin production and the previously reported association of the UCP1 -3826A-->G variant with obesity. A total of 160 men and 172 women randomly chosen from a nationwide population-based obesity cross-sectional survey in Spain were studied. Body mass index (BMI), waist-to-hip ratio (WHR), leptin, insulin, fasting and 2-hour post-glucose load glycemia, high-density lipoprotein (HDL)-, low-density lipoprotein (LDL)-, and total cholesterol, and triglyceride plasma levels were measured. beta(3)-AR Trp64Arg and UCP1 -3826A-->G genotypes were determined by restriction fragment length polymorphism-polymerase chain reaction (RFLP-PCR). UCP1 -3826G allele frequency was higher in men than in women (0.31 v 0.22, P = .015) and in obese women than in non-obese women (0.31 v 0.17, P = .008). Women carriers of the Arg64 or the alleles also showed higher leptin levels than noncarriers. Multiple linear regression analysis showed that the Arg64 allele is associated with higher leptin levels after the adjustment for gender, age, WHR, and the degree of glucose tolerance. In conclusion, the beta(3)-AR Trp64Arg polymorphism might have an impact on the mechanisms involved in leptin release from adipose tissue. Furthermore, our results agree with the previously reported association between UCP1 -3826G allele and obesity and point to a gender-related effect.

Abstract: OBJECTIVES: A meta-analysis of 11 randomized trials was done to compare stenting versus balloon angioplasty (BA) in small coronary vessels. BACKGROUND: Randomized studies on coronary stenting (CS) in small vessels have yielded controversial results. METHODS: Eleven randomized trials on CS versus BA in small vessels, including angiographic re-evaluation at six months, were analyzed. RESULTS: The BeStent (Medtronic Instent, Minneapolis, Minnesota) was used in four studies, the Multi-Link (Guidant, Advanced Cardiovascular Systems Inc., Santa Clara, California) in three trials, and the NIR (Boston Scientific Corp., Boston, Massachusetts), JoStent (Jomed International AB, Helsingborg, Sweden), Tenax (Biotronik, Berlin, Germany), and BioDivysio (Abbott Vascular Devices, Redwood City, California) in the remaining four trials. Overall, 3,541 patients were included (1,672 allocated to BA and 1,869 to stent). The rate of cross-over from balloon to stent in the pooled population was 19%, and unsuccessful stent deployment occurred in 2% of the patients allocated to stent. The pooled rates of restenosis were 25.8% and 34.2% in patients allocated to stent and balloon, respectively (p = 0.003) (risk ratio [RR] 0.77; 95% confidence interval [CI] 0.65 to 0.92). A smaller reference vessel diameter at baseline was associated with a higher risk reduction in the restenosis rate (y = -3.551 + 1.826 [x]; p = 0.012). Patients allocated to stent had lower rates of major adverse cardiac events (15.0% vs. 21.8%, p = 0.002; RR 0.70; 95% CI 0.57 to 0.87) and new target vessel revascularizations (12.5% vs. 17.0%, p = 0.004; RR 0.75, 95% CI 0.61 to 0.91). CONCLUSIONS: Elective stenting is superior to provisional stenting in small coronary arteries. This benefit is more evident in smaller coronary arteries.

Abstract: AIMS: In patients with in-stent restenosis (ISR) several anatomic subgroups have been identified. ISR affecting the stent edge (EDG) is a poorly characterised subgroup with undefined therapeutic implications. We sought to determine the implications of ISR affecting the stent EDG. METHODS AND RESULTS: 450 patients included in the "Restenosis Intra-stent: Balloon angioplasty vs elective Stenting" (RIBS) randomized study, were analysed. EDG ISR was predefined in the protocol and the pattern of ISR analysed in a centralized core-lab. Fifty-two patients (12%) had EDG ISR (29 stent group, 23 balloon arm). Patients with EDG ISR had less severe [minimal lumen diameter (MLD) (0.78+/-0.3 vs 0.66+/-0.3 mm, p=0.05)] and shorter lesions (lesion length 10.2+/-6 vs 13.2+/-7 mm, p=0.003). Patients with EDG ISR more frequently required crossover (12% vs 3%, p=0.006) but eventually the immediate angiographic result and the long-term clinical and angiographic outcome was similar to that found in patients without EDG ISR. Patients with EDG ISR treated in the balloon and stent arms had similar baseline characteristics. However, after intervention, the immediate angiographic result was better in the stent arm (MLD 2.79+/-0.4 vs 2.35+/-0.3 mm, p=0.001). This difference persisted at late follow-up: MLD (1.93+/-0.7 vs 1.39+/-0.7 mm, p=0.01), recurrent restenosis (20% vs 50%, p=0.03). In addition, the 1-year event-free survival was significantly better (83% vs 52%, log rank p=0.01; Cox HR 0.28, 95%CI 0.09-0.79) in the stent arm. Moreover, stent implantation was an independent predictor of freedom from target vessel revascularization (HR 0.15, 95%CI 0.03-0.67, p=0.003). CONCLUSIONS: EDG ISR constitutes a specific subgroup with relevant therapeutic implications. In patients with EDG ISR, repeat stent implantation provides better clinical and angiographic outcome than conventional balloon angioplasty.

Abstract: PURPOSE: The objective of the present study was to determine whether dry eye (DE) associated with primary Sjögren's syndrome (PSDE) and DE not associated with Sjögren's syndrome (NSDE) are related to an alteration of corneal innervation. METHODS: Eleven healthy volunteers younger than 60 years (normal [N] < 60 group), 10 healthy volunteers 60 years of age or older (N > or = 60 group), 11 patients with PSDE, and 10 patients with NSDE were studied. Epithelial and stromal density and subbasal and stromal nerves were investigated by confocal microscopy. RESULTS: The density of the superficial epithelial cells was 741 +/- 306 cells/mm2 in the PSDE group; 1022 +/- 331 cells/mm2 in the NSDE group; 1523 +/- 294 cells/mm2 in the N > or = 60 group, and 1529 +/- 341 cells/mm2 in the N < 60 group (P < 0.0001, ANOVA). The number of subbasal nerves was 2.8 +/- 1.2 in the PSDE group, 3.3 +/- 0.7 in the NSDE group, 3.1 +/- 0.9 in the N > or = 60 group, and 4.6 +/- 0.8 in the N < 60 group (P < 0.0001, ANOVA). The number of beadlike formations observed in the different groups was 387 +/- 62/mm in the PSDE group, 323 +/- 64/mm in the NSDE group, 182 +/- 63/mm in the N > or = 60 group, and 198 +/- 66/mm in the N < 60 group (P < 0.0001, ANOVA). A correlation was found between the number of subbasal nerves and age (P < 0.01) and between the number of subbasal nerves and Schirmer's test (P < 0.001, Spearman rho). CONCLUSIONS: Patients with DE show alteration in the corneal innervations. The demonstration of such alterations introduces new strategies for treatment of this frequent disease.

Abstract: Immunocompromised renal transplant recipients are susceptible to severe cytomegalovirus (CMV) infection that makes its detection important in clinical practice. A total of 536 blood and 536 serum samples from 67 renal transplant recipients who had previously been diagnosed with terminal renal insufficiency were studied for CMV infection. In all samples, serology, shell vial culture, antigenaemia and nested polymerase chain reaction (PCR) in blood and serum were tested, and a real-time quantitative PCR was run on 90 specimens. Sixty-seven blood donors were used as controls. The results show that the quantitative real-time PCR assay could be of great interest for predicting CMV disease, and to monitor the onset of pre-emptive therapy.

Abstract: INTRODUCTION AND OBJECTIVE: Rescue percutaneous transluminal coronary angioplasty (PTCA) is a mechanical reperfusion strategy aimed at achieving patency of the infarct-related artery after failed thrombolysis. However, in randomized studies the indication for rescue PTCA was per protocol rather than based on clinical criteria. The aim of this study was to determine predictors of mortality at 30 days following rescue percutaneous intervention. PATIENTS AND METHODS: Seventy-one consecutive patients who underwent rescue PTCA were included. Mean age was 61 (11) years, 80% were men and 9.8% had diabetes. RESULTS: The infarct-related artery was the left anterior descending artery in the 46.5%, and the mean percentage of stenoses was 91.0 (11.6)%. A stent was implanted in 97.2% and TIMI II-III flow was obtained in the 97.2% of the patients. Overall mortality was 9.8% at 30 days follow-up and 11.3% at 1 year follow-up. In the multivariate analysis, the independent predictors of mortality at 30 days were age (OR=1.2, 95% CI: 1.03-1.5, P=.001), Killip class III-IV (OR=20.1; 95% CI: 1.7-500; P=.003), PTCA failure (OR=indeterminate; P=.04) and left anterior descending artery involvement (OR=12.6; 95% CI: 0.7-214.9; P=.04). CONCLUSIONS: Rescue PTCA is effective in restoring blood flow in the infarct-related artery in the majority of patients in whom thrombolysis failed. The independent predictors of mortality were similar to those previously reported in acute myocardial infarction.

Abstract: INTRODUCTION AND OBJECTIVES: Among the complications of infective endocarditis, systemic embolisms are an ominous prognostic sign. The aim of the present study was to compare the demographic, clinical, microbiologic and echocardiographic features of episodes of endocarditis accompanied and unaccompanied by embolisms in the spleen, kidney or liver. We also assessed the prognostic impact of these embolisms. MATERIAL AND METHOD: Prospective, multicenter clinical cohort study. We analyzed 338 consecutive episodes of left-sided infective endocarditis in 308 patients. Episodes were classified in two groups: group I, episodes with hepatosplenic or renal embolisms (n=34); group II, episodes without embolisms (n=304). RESULTS: There were 41 embolisms in 34 episodes (10%). Of these, 34 were located in the spleen, 5 in the kidney and 2 in the liver. Some forms of clinical presentation predominated in group I, e.g., abdominal pain, splenomegaly, cutaneous stigmata, hematuria, embolisms in other locations, and septic shock. Staphylococcus aureus and enterococci were more commonly isolated in group I. Detection of vegetations (by transesophageal echocardiography) was more frequent in group I, and they were larger than vegetations in group II. Hepatosplenic and renal embolisms were not independently associated with the need for cardiac surgery or death. CONCLUSIONS: Hepatosplenic and renal embolisms occur in 10% of left-sided episodes of infective endocarditis. The clinical presentation of these episodes has characteristic features. Vegetations are larger than in episodes without these embolism. Hepatosplenic and renal embolisms do not increase neither the need of cardiac surgery nor the risk of death.

Abstract: AIM: To assess whether combining neuropsychological tests and cerebral blood flow markers improves progression accuracy from mild cognitive impairment (MCI) to Alzheimer's disease (AD) than each of them on its own. METHODS: Forty-two patients were investigated prospectively, undergoing baseline and 3-year follow-up neuropsychological tests and neuroimaging with Tc-ECD-SPECT. Twenty-one patients had developed AD while 21 retained their initial diagnosis. The relative blood flow and cognitive differences were studied. Validity parameters, multivariant analysis and logistic regression model were calculated. RESULTS: Patients who deteriorated showed lower scoring than stable subjects in some neuropsychological tests (p = 0.03-0.001) and in relative blood flow in selected regions (8-10%). Low cognitive test scoring and low relative blood flow in some regions showed sensibilities and specificities from 70% to 86% for the diagnosis of early Alzheimer's disease. The relative risk of progression to AD was up to 4.7 times higher for these patients (p = 0.0001). The left frontal relative blood flow, the CAMCOG and orientation scoring were the best data to predict the risk of progression to AD. CONCLUSIONS: The combination of functional imaging and neuropsychological tests can diagnose with high sensitivity and specificity if a patient is suffering cognitive impairment in its early stages, and may aid in predicting the risk of developing dementia.

Abstract: OBJECTIVES: We studied the efficacy of intracoronary brachytherapy (ICB) after successful coronary stenting in diabetic patients with de novo lesions. BACKGROUND: Intracoronary brachytherapy has proven effective in preventing recurrences in patients with in-stent restenosis. However, the role of ICB for the treatment of de novo coronary stenoses remains controversial. METHODS: Ninety-two patients were randomized to either ICB or no radiation after stenting. Primary end points were in-stent mean neointimal area (primary end point of efficacy) and minimal luminal area of the entire vessel segment (primary end point of effectiveness), as assessed by intravascular ultrasound at six-month follow-up. Quantitative coronary angiography analysis was performed at the target, injured, irradiated, and entire vessel segments. RESULTS: At follow-up, the in-stent mean neointimal area was 52% smaller in the ICB group (p < 0.0001). However, there was no difference in the minimal luminal area of the vessel segment (4.5 +/- 2.4 mm2 vs. 4.4 +/- 2.1 mm2). Restenosis rates increased progressively by the analyzed segment in the ICB group: target (7.1% vs. 20.9%, p = 0.07), injured (9.5% vs. 20.9%, p = NS), irradiated (14.3% vs. 20.9%, p = NS), and vessel segment (23.8% vs. 25.6%, p = NS). At one year, 1 cardiac death, 6 myocardial infarctions (MIs) (3 due to late stent thrombosis), and 10 target vessel revascularizations (TVRs) (6 due to the edge effect) occurred in the ICB group, whereas in the nonradiation group, there were 11 TVRs and no deaths or MIs. CONCLUSIONS: Intracoronary brachytherapy significantly inhibited in-stent neointimal hyperplasia after stenting in diabetic patients. However, clinically this was counteracted by the occurrence of the edge effect and late stent thrombosis.

Abstract: The amplification and/or overexpression of the c-erbB-2/neu oncogene may play a role in tumor development and progression. The aim of this prospective study was to evaluate the prognostic value of p185 protein in colorectal cancer using immunohistochemical techniques. We analyzed 106 colorectal tumor tissue specimens from patients who had been operated on by the same surgeon and subjected to a median follow-up of 3 years. Thirty-three per cent of patients showed p185 overexpression related to an advanced stage of the disease. In patients with adenocarcinoma tumors of the colon without distant metastases, p185 detection was found to be of clinical prognostic relevance (p = 0.06).

Abstract: BACKGROUND: A 300 mg clopidogrel loading-dose (LD) is widely used as an adjunct antithrombotic treatment to reduce the risk of thrombotic events early after coronary stenting (CS). Antithrombotic drugs commonly used during percutaneous coronary interventions, such as heparin and platelet glycoprotein IIb/IIIa inhibitors, but not clopidogrel LD, are weight-adjusted, and few data are available on which is the most effective clopidogrel LD regimen. The aim of this study was to assess whether body mass index (BMI) influenced platelet response to clopidogrel LD in patients undergoing CS. METHODS: Adenosine diphosphate (ADP)-induced platelet aggregation (PA) was assessed by light transmittance aggregometry in 48 patients on aspirin treatment undergoing CS receiving a 300 mg clopidogrel LD at intervention time. PA was assessed at baseline and up to 24 hours after intervention. Patients were divided into 2 groups according to BMI: overweight (BMI greater than or equal to 25 kg/m2; 29 patients) and normal weight (BMI<25 kg/m2; 19 patients). PA was significantly higher in overweight than in normal weight patients at baseline (60.1+/-18.6%; versus 47.6+/-13.5%; p=0.01), at 24 hours (42.3+/-18.4% versus 38.5+/-18.3%; p=0.02) and during the overall study time (p=0.025). Percentage of inhibition of PA 24 hours following clopidogrel LD was suboptimal (<40%) in 59% and 26% of overweight and normal weight patients, respectively (p=0.04). An elevated BMI was the only independent predictor of suboptimal platelet response. CONCLUSION: These data suggest that overweight patients may need a higher loading-dose of clopidogrel and/or an adjunct antithrombotic treatment to adequately inhibit platelet aggregation early after CS.

Abstract: PURPOSE: To develop a simple method for the clinical evaluation of tear dynamics and evaluate its usefulness in the diagnosis of dry eye syndrome. METHODS: The study includes 170 eyes from 85 adults. 102 eyes had a Schirmer's test value of less than 10 mm and subjective symptoms of dry eye. Tear function index (TFI) was calculated in all the cases using prepared drops with 0.5% fluorescein and 0.4% oxibuprocaína. Five minutes later a Schirmer strip was placed on the conjunctival fornix. Schirmer's test and tear clearance were calculated after a further five minutes. Tear clearance was measured using a table of fluorescein concentrations. TFI is the quotient between the value of the Schirmer's test and TCR. RESULTS: The cut-off value of TFI in dry eye is 74. At this point the sensitivity of this method is 74% and the specificity is 63%. The Schirmer's test results did not correlate with the tear clearance results. CONCLUSION: TFI is a rapid and sensitive method of identification of subjects with dry eye. The lack of correlation between TFI and TCR is because these methods evaluate different aspects of tear dynamics.

Abstract: The PlA polymorphism (Leu33Pro) of the platelet glycoprotein (GP) IIIa gene has been suggested to play an important role in coronary thrombosis. In vitro studies have shown differences for this polymorphism in platelet sensitivity towards antiplatelet drugs (aspirin and abciximab), suggesting a pharmacogenetic modulation. The aim of the study was to assess the modulatory effect of the PlA polymorphism on clopidogrel-induced antiplatelet effects in 38 patients undergoing coronary stent implantation receiving a 300 mg clopidogrel loading-dose. Platelet reactivity was assessed as GPIIb/IIIa activation and P-selectin expression in platelets stimulated with 2 micromol/l adenosine diphosphate using whole blood flow cytometry. The distribution of the homozygous PlA1/A1 and heterozygous PlA1/A2 genotypes were 74 and 26%, respectively. PlA2 carriers had a higher degree of GPIIb/IIIa activation (P = 0.05) and P-selectin expression (P = 0.02) during the overall study time course and a lower antiplatelet effect to a 300 mg clopidogrel loading-dose up to 24 h following intervention (P < 0.05). In conclusion, the Pl polymorphism of the GPIIIa gene modulates platelet reactivity towards clopidogrel front loading in patients undergoing coronary stenting. This suggests the need for individualized antithrombotic regimens to optimally inhibit platelet reactivity.

Abstract: OBJECTIVES: To evaluate the value of plasma fibronectin (pFN) as a diagnostic marker of sepsis. SUBJECTS AND METHODS: Plasma FN was determined in patients showing sepsis-related symptoms who had blood cultures performed. These patients were assigned to one of two groups according to their clinical situation: (1) Clinical Septic Group: patients with sepsis according to American College of Chest Physicians/Society of Critical Care Medicine (ACCP/SCCM) criteria; (2) Fever Peak Group: patients who did not fulfil sufficient ACCP/SCCM criteria for sepsis. Two additional control groups were also established: (3) Non-infectious Diseases Control Group and (4) Healthy Control Group. RESULTS: Plasma FN levels, microbiological and clinical data were compared among the different patient groups. For each group, the number of patients, median and mean pFN levels and the 95% confidence interval of the mean were: (1) n = 43, 102 mg/l, 122 mg/l (100-144); (2) n = 70, 185 mg/l, 207 mg/l (184-231); (3) n = 22, 175 mg/l, 181 mg/l (151-211); and (4) n = 22, 256 mg/l, 261 mg/l (229-292). Bonferroni's test of multiple comparisons was able to detect a significant difference between pFN concentrations corresponding to the septic group, compared to the remaining groups (pANOVA < 0.001 ). CONCLUSION: Plasma FN appears to act as a marker of sepsis in that patients showed diminished pFN levels. Along with other clinical and laboratory variables, the use of this marker would allow a rapid diagnosis of sepsis and limit the number of blood cultures to be processed and the number of antibiotic prescriptions, particularly when symptoms are insidious and diagnosis is doubtful. We propose further and more complex studies using a higher number of patients.

Abstract: Prognosis is a description of the course of a disease from the beginning. In comparison to risk factors, prognostic factors are relatively frequent and may often be estimated by our personal clinical experience. Nevertheless, the cases of diseases usually cared for at hospitals and described in the medical bibliography are often biased samples and have the tendency to overestimate severity. Cohort studies imply follow-up of the groups of individuals over time. They are the observational studies with the highest acceptance within the scientific community, because they include the target population in the study. If we look for providing solid information, the observation of the members of a cohort, independently of what they have in common, should comply with two criteria: 1. Cohorts should be observed for a significant period of time of the natural history of the event studied. 2. All members in a cohort should be observed for the full follow-up period. As in any cohorts observation, studies comparing prognosis among various groups of patients may be blased if differences appear due to cohort recruitment methods, patients shifting from their initial groups, and unequal results evaluation.

Abstract: The design of an epidemiological study includes the procedures, methods and techniques by which the researcher tries to obtain valid (avoiding systematic errors or bias) and precise (avoiding random errors) answers to the research question posed. This principal question aimed to be answered is the specific objective of the study, which guides the election of an adequate type of design. The objective of this article is to describe the classification criteria (finality, temporal sequence, directionality, and control of the assignation of different study factors) of the different types of epidemiological studies (experimental, almost-experimental, and observational) and the main advantages, disadvantages, utilities and objectives of each investigation design.

Abstract: Diagnosis is a process characterized by uncertainty, which the researcher can approach through knowledge based on the theory of probability, and, as such, it is part of the general decision-making process. To use a test is a process that helps to confirm or refuse the initial probability of the patient to be sick. In this article, we analyze the essential characteristics of diagnostic tests and the principles of effective evaluation of the studies about these tests. We explain in detail what reliability of an instrument is, the types of reliability that there are, and how to analyze them. So that, we introduce concepts such as Pearson's correlation coefficient, intra-class correlation coefficient, and Cohen's Kappa coefficient. Another topic described in this article is measurement of validity, defining the types of validity to be considered on an instrument. Finally, we treat the general principles that rule the design and execution of a study for the evaluation of diagnostic tests, the structure followed by these studies, and mainly the analysis, intention of which is to evaluate to what extent that diagnostic test differentiates between subjects with and without the disease studied. We explore the concepts of sensitivity, specificity, predictive values, and probability ratios, and ROC curves are explained.

Abstract: METHODS: An open-label multicentre study was conducted in primary care centres in Spain to investigate the effect of a switch from celecoxib to rofecoxib among patients with osteoarthritis and to identify factors associated with a good response to rofecoxib treatment. Patients were eligible to participate in this study if their physicians considered that they might benefit from such a change of therapy. A total of 2,228 patients (1481 women) were enrolled in the study: participants' mean age was 66.37 years (SD 9.04). Mean duration of OA was 7.44 (6.38) years. Predominant sites of OA included the knee (1,132 patients, 50.8%), lumbar spine (977 patients, 43.9%) and cervical spine (739 patients, 33.2%). At baseline, most patients (77%) were being prescribed celecoxib 200 mg/day; during the study most (92.5%) received rofecoxib 25 mg/day. The mean interval between switch to rofecoxib and follow-up interview was 33 days. Principal results: Patients considered the therapeutic response to rofecoxib substantially and significantly superior to that previously obtained with celecoxib for the management of OA-related pain and OA-related health status (p < 0.001). Seventy-two percent of patients classified their response to rofecoxib therapy as 'good' or 'very good' (vs 6.6% of patients at baseline with celecoxib) and 89.3% of patients expressed satisfaction with rofecoxib (vs 28.9% at baseline with celecoxib). Improvements reported in patient self-assessments following rofecoxib therapy were complemented by similar changes in physician perceptions. The number of patients considered by their doctors to have 'good' or 'very good' OA-related health status rose from 10.1% at baseline to 80.0% on completion of rofecoxib therapy. Ancillary indices such as the proportion of patients with self-reported depression were also favourably influenced by the switch to rofecoxib from celecoxib. Determinants of response: Patient characteristics identified in multivariate analysis as predictive of a favourable response to rofecoxib comprised age, obesity, depression, diabetes and OA-related overall health status. CONCLUSIONS: The results of this observational study indicate that rofecoxib 25 mg/day is likely to be more effective in patients with OA who do not respond well to celecoxib 200 mg/day and satisfies a large proportion of both patients and physicians. These data are of practical interest because they indicate that, at the doses most often used in primary practice in Spain to treat OA, many patients who are dissatisfied with the effects of celecoxib 200 mg/day may benefit from a switch to rofecoxib 25 mg/day. The data obtained in this study also reveal that younger OA patients with relatively uncomplicated clinical circumstances (a population in which use of Coxibs is relatively low at present) are likely to derive substantial benefit from a switch to rofecoxib therapy.

Abstract: OBJECTIVE: Given the important role of the beta2-adrenoceptor (beta2-AR) in lipid mobilization and the lack of studies in Southern European countries, the aim of this study was to investigate the role of the glutamine 27 glutamic acid (Gln27Glu) beta2-AR polymorphism in the susceptibility to obesity and its metabolic complications in a population-based nationwide multicentre study in Spain, especially focusing on the hypothetical influence of gender. DESIGN: Cross-sectional population-based study. PATIENTS: We studied 666 nonrelated adults (47.9% men and 52.1% women), aged 35-64 years, chosen randomly from a nationwide population-based survey of obesity, and related conditions including insulin resistance and cardiovascular risk factors. MEASUREMENTS: Body mass index (BMI), waist-to-hip ratio (WHR), sagittal abdominal diameter (SAD), systolic and diastolic blood pressure, fasting and 2-h post-glucose load glycaemic levels, total cholesterol, high density lipoprotein (HDL)- and low density lipoprotein (LDL)-cholesterol, triglycerides, insulin, proinsulin and leptin plasma levels were measured. Beta2-AR Gln27Glu genotypes were determined by restriction fragment length polymorphism (RFLP)-polymerase chain reaction (PCR). RESULTS: Glu27 homozygous obese men had significantly higher BMI and SAD mean values than both heterozygous and Gln27 homozygous obese men. Two-hour post-load plasma glucose concentration was higher in Glu27 homozygous than in Gln27 homozygous in the whole population and only in men when stratified by gender. No differences according to the genotype were found for the rest of the parameters studied, including homeostasis model assessment (HOMA), insulin, proinsulin and leptin levels, but for total and LDL-cholesterol these increased in men. We did not find differences in the anthropometrical and biochemical parameters according to the genotype in women. Multivariate logistic regression analysis showed that Glu27 homozygosity after adjustment for SAD was associated with type 2 diabetes mellitus. CONCLUSIONS: Our results suggest that the glutamic acid 27 allele of the beta2-adrenoceptor may be a risk factor in men but not in women for the accumulation of visceral fat and for its association with the development of type 2 diabetes mellitus.

Abstract: The use of statistics in medical articles has risen a lot during the last decades, however it is used in a thoughtless manner in many instances. Today, Statistics is the only tool that allows the medical researcher to obtain results and benefits from those studies the relationships of which can not be interpreted from a determinist perspective, because it is a branch of applied mathematics objective of which is to manage and quantify the uncertainty of the available information, to support decision taking. The objective of this article is to review the basic statistical concepts that every doctor should know to be able to perform and/or detect quality research, as well as to underline the most frequent errors committed when interpreting statistical results. We review the general concepts about data synthesis and differentiation of the different types of measurements, hypothesis testing and errors that can be committed doing it, the real meaning of the "p" value, differentiation between statistically significant and clinically relevant results, the importance of confidence intervals as a measure of significance and clinical relevance, the confusion generated between two concepts that are different as standard deviation and standard error, and the criteria that govern the selection of the adequate statistical tests to evaluate relationships between variables.

Abstract: Publication of a scientific work is the final and obligatory stage of any research. Among the various existing types of medical publications, the research original article is the prototype of scientific article. Its finality is to communicate the investigation undertaken to the reader in a coherent, clear and precise manner. With that purpose, the discoveries found by the authors as an answer to a hypothesis are presented and discussed. To send the original article to a biomedical journal, the manuscript should present some adequate formal characteristics, in addition to contain scientifically valid information. That can be achieved by complying with the rules past by the International Committee of Biomedical Journal Editors which have been adopted by a great number of scientific journals as publication requisites. The objective of this article is to describe the structure of the various parts (first page, abstract, introduction, material and methods, results, discussion, and bibliographic references) that constitute the format of the research original article, exposing the main adverse to be avoided during its preparation.

Abstract: BACKGROUND: The aim of the present study was to investigate the effect of different dialysate buffer and glucose concentrations, membrane surface (S) bigger than 2 m2 and increased dialysate flow (Qd) in phosphate (P) removal. METHODS: A. First phase (5 patients): the following variations in dialysate composition were introduced. A: glucose 1.60 g/L, bicarbonate: 39 mEq/L, acetate 4 mEq/L, B: glucose 1.5 g/L bicarbonate 17 mEq/L, acetate 10 mEq/L; C: glucose 0, bicarbonate: 39 mEq/L, acetate 4 mEq/L; and D: glucose 0, bicarbonate 17 mEq/L, acetate 10 mEq/L. B. Second phase (14 patients): variations in S and Qd were: 1. Qd: 500 mL/min + Hemophan 2 m2, 2. Qd: 500 mL/min + Hemophan 2.6 m2, 3. Qd: 750 mL/min + Hemophan 2 m2, 4. Qd: 750 mL/min + Hemophan 2.6 m2. RESULTS: Comparing HDs performed with low bicarbonate (B and D) respect to current buffer formulations (A and C), total P removal was 997.3 (+/- 237.3) vs 882 (+/- 216.1) mg (p NS). No differences were found by grouping the sessions according to glucose concentration. There were no significant differences in total phosphate removal between the two different S or Qd. The most important predictive factor of total P removal was the initial P and 2 hours serum P concentration, and PTH concentration. CONCLUSIONS: i) Removal of P is better predicted by pre-dialysis P serum concentration; ii) P removal was not affected by the changes in bicarbonate and glucose concentration in the dialysate; iii) the increase of the dialyzer area between 2 and 2.6 m2 augments Kt/V, but without influencing P elimination; iv) a higher Qd does not determine significant differences in P removal and v) higher PTH is associated with a higher P elimination.

Abstract: Immunomodulation in cancer has obvious appeal. Available data suggest the central role to be played by the host immune response in cancer outcome. Herein, we report a novel compound, Blood Leukocyte Augmenting Substance 236 (Cl(-)) [BLAS 236 (Cl(-))], which is able to restore and/or strengthen immunocompetence, which is critical in host-resistance to malignancy. The effects of several protocols in which BLAS 236 (Cl(-)) was given as single-agent or combined therapy on established murine tumors were evaluated in terms of long-term tumor-free survivors (>1 year). Treatment significantly improved overall complete response and survival rates and prolonged the life span of mice to beyond that of animals receiving placebo. The most outstanding protocols (denoted B3, B6 and D6, D7), were able to flatten tumor-free survival curves at the 80% and 100% levels, respectively (P < 0.001 for each protocol); these results compare favorably with those reported for other preclinical trials. Immunomodulation by BLAS 236 (Cl(-)) is viewed as a new efficient, safe way of potentiating and maintaining host-resistance to malignancy that holds promise as an adjuvant therapy alternative to current immune approaches for the ultimate cure of cancer.

Abstract: BACKGROUND: The management of anemia with erythropoietin (EPO) is important in the global treatment of dialysis patients. There is a general impression that anemia control with EPO is obtained more easily in peritoneal dialysis (PD) patients than in hemodialysis (HD) patients. The EPO administration route has to be the same to compare the two techniques adequately. METHODS: To compare EPO action by subcutaneous (SC) route in HD and PD, 132 stable patients were recruited (HD: 69, PD: 63) from six centers, with adequate dialysis criteria (Kt/V in HD >1.3; weekly Kt/V in PD >1.8). In a cross-sectional study, the EPO dose/week, the number of EPO doses/week, hemoglobin (Hb), ferritin, transferrin saturation index (TS), albumin and intact parathyroid hormone (iPTH) were analyzed. Iron treatment, comorbidity and ACE inhibitors (ACEI) and angiotensin II antagonist (AIIA) treatment were recorded. A multivariate regression model was used in the statistical analysis. RESULTS: The mean Hb level was the same in both groups, HD 11.6 (1.3) g/dL, PD 11.4 (1.4) g/dL, p=0.3. The SC, EPO doses required to obtain the Hb levels were higher in HD than in PD patients, with a difference of 64.3 u/Kg/week, statistically significant in the multivariate regression model (p=0.001, 95% CI 42.6-86.0). The number of EPO doses/week was also higher in HD patients (65% of HD patients with > or = 3 doses, 19% of PD patients with three or more doses, p<0.001). TS was similar in both groups, while ferritin was higher in HD patients, with a higher percentage of HD patients using intravenous (i.v.) iron (HD 77% vs. PD 49%, p=0.001). Serum albumin and iPTH were lower in PD patients (p<0.001 and p=0.04, respectively), but the percentage of patients with intact parathyroid hormone (iPTH) >500 pg/mL was similar in both groups (HD 17%, PD 14%). CONCLUSIONS: With the same administration route, PD patients showed a reduced EPO requirement, and less frequent EPO administration than HD patients, to obtain the same Hb level. No other factors, except those involved in better depuration of erythropoiesis inhibitors in PD, seemed responsible for the different EPO requirements.

Abstract: OBJECTIVES: a) establish the major immunological parameters for clinical use in a group of retirees; b) correlate its levels in relation to gender; c) assess the influence of some specific factors (substance abuse, diseases) on the analyzed parameters. MATERIAL AND METHODS: study period: 1990-1999; sample: 249; 102 men (M); 147 women (W). Median age: 67.03 (4.2) years. Analyzed immunological variables: total leukocytes, lymphocytes B, immunoglobulins (IgG, IgA and IgM), rheumatoid factor, lymphocytes subpopulations (CD4, CD8, ratio), natural killer, complement (C3 and C4) and delayed hypersensitivity tests. TECHNIQUES: flow cytometry (EPICS-Profile II) and Multitest IMC. Statistical analysis: SPSS version 10.0.Results. Gender influence: leukocytes: M: 6,699.4 (1,615.0); W: 6,105.9 (1,470.5); p < 0,003; lymphocytes B (%): M: 9.4 (5.0); W: 11.3 (4.1); p < 0,003; IgG: M: 1,155.7 (320.0); W: 1,116.1 (257.8); p = 0,28, IgM: M: 112.7 (69.3); W: 136.8 (85.6); p < 0,01; IgA: M: 276.1 (114); W: 254.0 (122); p = 0,15; rheumatoid factor: M: 18.5 (6.6); W: 20.9 (18.8); p = 0,020; CD4 (%): M: 42.2 (9.7); W: 47.3 (9,1); p < 0.001; CD8 (%): M: 30.3 (10,8); W: 25.0 (10.2); p < 0,001; scores: M: 13.2 (7.4); 11m: 10.0 (7.2); p < 0,005. Influence of the substance abuse: smokers; lymphocytes B (%): 8.8 (3.4); No: 10.9 (4.7); p < 0.008; CD8 (%): smokers: 31.8 (13.2); No: 26.2 (9.9); p < 0.003; CD4/CD8 ratio: smokers: 1.6 (0.9); No: 2.0 (1.3); p < 0,05; scores: smokers: 14.3 (6.8); No: 10.8 (7.5); p < 0.02; alcoholism: lymphocytes B (%): 8.7 (2.5). No: 10.8 (4.7); p < 0.001; alcoholism: store: 16.9 (6.7); No: 10.7 (7.3); p < 0,001. Influence of the diseases: diabetes: CD4 (%): 49.4 (12.0); diabetics versus healthy: p = 0,05; CD4/CD8 ratio: 2.6 (2.5); diabetics versus healthy: p = 0,04; EPOC: CD8 (%): 32.9 (16,3); COPD versus healthy: p = 0,07; neoplasias NK (%): 17.1 (21.4); neoplasias versus healthy: p < 0,01. CONCLUSIONS. a) there are differences according to the gender in the parameters of normalcy of some variables; b) smoking and alcoholism alter the immunological test analyzed, and c) some chronic diseases influence the subpopulations of lymphocytes and the cutaneous test of delayed hypersensitivity.

Abstract:

Abstract: Clinical epidemiology is the science and method of studying the optimal decisions in clinical medicine, taking into consideration the epidemiological characteristics of the patient and his/her external clinical environment, the disease involved, and factors and procedures to which the patient is exposed in his/her clinical environment, specially clinical actions. Research should be a systematic process, organized and objective, aimed to answer the question posed. Systematic means that the scientific method is applied, for that a hypothesis or work objective is formulated from observations or established knowledge about a topic, data are collected following a pre-established design, and, once analyzed and interpreted, conclusions are obtained which will modify or add new knowledge to the previous, and a new cycle starts again. Organization means that all members in the research team know perfectly what to do during the whole study, apply the same definitions and criteria to all participants, and act in identical way in front of any doubt. To achieve this, it is mandatory to write a protocol specifying all details related to the study. The meaning of the word objective is that conclusions obtained are not based on subjective impressions but on facts that have been observed, measured, and analyzed, and that any prejudice the study responsibles could have is avoided during its interpretation.

Abstract: Epidemiology develops measurements that allow to quantify the occurrence of disease within the population. There are three types of measurements: frequency measurements, explained in this article; association measurements, between the occurrence of disease and some characteristics, the effect of which on the disease is what they intend to measure; and measurements of the potential impact that modification or disappearance of some risk factors would have on the occurrence of disease in the population. The first objective of epidemiological studies is the knowledge of the frequency of disease. There are three basic measurements of frequency of a disease. Prevalence measures the proportion of people that has it in a given moment. Cumulative incidence measures the proportion of people that convert from non-sick individual to sick individual during a specified period of time. Incidence rate is a measure of the instantaneous strength of occurrence of the disease.