Efficacy and safety of the coadministration of ezetimibe/simvastatin with fenofibrate in patients with mixed hyperlipidemia.

BACKGROUND: Mixed hyperlipidemia is characterized by elevated low-density lipoprotein cholesterol (LDL-C), triglyceride (TG), and TG-rich lipoprotein levels. METHODS: In a multicenter, randomized, double-blind, placebo-controlled, parallel arm trial, eligible patients were 18 to 79 years of age, with mixed hyperlipidemia (LDL-C 130-220 mg/dL, TG 150-500 mg/dL). Patients with type 2 diabetes were limited to those with LDL-C of 100 to 180 mg/dL. Patients (N = 611) were randomized in a 3:3:3:1 ratio to one of 4 treatment arms for 12 weeks: ezetimibe/simvastatin 10/20 mg (EZE/SIMVA) + fenofibrate 160 mg (FENO), EZE/SIMVA 10/20 mg, FENO 160 mg, or placebo. The primary objective was to evaluate the LDL-C-lowering efficacy of EZE/SIMVA + FENO versus FENO monotherapy. RESULTS: Low-density lipoprotein cholesterol level was significantly (P < .05) reduced with EZE/SIMVA + FENO (-45.8%) compared with FENO (-15.7%) or placebo (-3.5%), but not when compared with EZE/SIMVA (-47.1%). High-density lipoprotein cholesterol and apolipoprotein A-I levels were significantly increased with EZE/SIMVA + FENO (18.7% and 11.1%, respectively) treatment compared with EZE/SIMVA (9.3% and 6.6%) or placebo (1.1% and 1.6%), but not when compared with FENO (18.2% and 10.8%). Triglyceride, non-high-density lipoprotein cholesterol, and apolipoprotein B levels were significantly reduced with EZE/SIMVA + FENO (-50.0%, -50.5%, and -44.7%, respectively) versus all other treatments. Treatment with EZE/SIMVA + FENO was generally well tolerated with a safety profile similar to the EZE/SIMVA and FENO therapies. CONCLUSIONS: Coadministration of EZE/SIMVA + FENO effectively improved the overall atherogenic lipid profile of patients with mixed hyperlipidemia. Clinical trial registry number: NCT 00093899 (http://www.ClinicalTrials.gov).

The impact of heart failure clinic in the improvement on quality of life of heart failure patients in Mexico.

Heart failure clinic (HFC) has emerged as an innovative strategy to improve prognosis and Quality of Life (QOL) of Heart Failure (HF) patients. Unfortunately, there is no-evidence of such benefit on HF patients by HFC in Latin-America. We undertake a research to investigate the impact of HFC on QOL in HF patients in Mexico. From October 2004 to July 2005 all patients that attended for the first time the HFC of the Specialties Hospital No 14 in Veracruz, Mexico were analysed. The study group included patients with HF and left ventricular systolic dysfunction (LVSD). QOL was measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). MLHFQ score was compared between basal vs 6 months follow-up. Every patient served as his/her own control. Forty-five HF patients were included and 34 completed 6 months follow-up. Four patients died within 6 months (mortality rate 12% [95% CI 2-22%]). Of the 30 remaining patients, median age was 61 years (range 37-74 years) and 47% was women with a mean left ventricular ejection fraction of 34%. The MLHFQ had a significant reduction at 6 months compared with basal condition from the first evaluation (Basal vs 6 months: mean [SD], 50 [26] vs 31 [19]; p = 0.0001) with a strong correlation between the MLHFQ score and NYHA functional class (p = 0.001; r = 0.59). HFC improves QOL of HF patients in Mexico. This disease management strategy would be considered for widely use in Latin-America countries.

Cardiovascular risk stratification by means of the SCORE system in health care workers in Veracruz, Mexico.

BACKGROUND: To assess cardiovascular disease risk by means of the SCORE system (Systematic Coronary Risk Evaluation) in health care workers (HCW) from Veracruz, Mexico. METHODS: A cross-sectional study was undertaken at the Mexican Institute of Social Security from Veracruz. Seventy six HCW without physical limitations (NYHA Functional Class I) were included. All HCW answered a standardised medical history questionnaire and were evaluated by physical examination and lab tests. The cardiovascular risk was assessed through the SCORE system. RESULTS: The median age of participants was 47 years (90% range 42-57 years), female HCW had higher prevalence of obesity and lower prevalence of overweight compared to male HCW (52% vs 23% for obesity and 26% vs 63% for overweight; p=0.014). The prevalence of hypertension was 22%, type 2 diabetes 8%, hypercholesterolemia 70%, hypertriglyceridemia 47% and mixed hyperlipidemia 26%. Cardiovascular risk assessed by the SCORE system showed that 14% of all patients had a cardiovascular risk higher than 2% and 51% had a risk lower than 1%. CONCLUSIONS: In this first study of cardiovascular risk assessment by means of the SCORE system in HCW in Mexico, we found that 14% of them have a cardiac risk higher than 2% and that it is double than expected for their age but it is lower than reported in a European population. Also, we found a higher prevalence of hypercholesterolemia and mixed hyperlipidemia showing poor education and treatment for cardiovascular prevention.

[Clinical utility of ultrasound in the identification of dengue hemorrhagic fever]. / Utilidad clínica del ultrasonido en la identificación de dengue hromorrágico.

OBJECTIVE: To evaluate the diagnostic utility of sonography in cases of dengue hemorrhagic fever (DHF) and to describe the correlation grade existing between the most frequent clinical and sonographic findings in DHF. MATERIAL AND METHODS: Prospective, cross-sectional and descriptive study applied to 132 patients, 21 of them with typical dengue fever and 111 with DHF. They went through ultrasound, searching for thickening of the gallbladder wall, pleural effusion and ascites. Dengue fever diagnosis was confirmed by positive IgM serology in all patients. Descriptive statistics, sensitivity and specificity tests, and phi contingency coefficient were used to obtain the correlation grade between clinical and sonographic findings present in DHF. chi2 was used to determine the statistics significance. RESULTS: Fever, retroocular pain and cephalea were found in more than 90% of the cases. The positive tourniquet test and petechiae were present in 70%, and thrombocytopenia, leukopenia and elevation of seric transaminases were found in 100% of the cases. Gallbladder thickening was present in 86% of the patients, pleural effusion in 66%, ascites in 60% and acute alithiasic cholecystitis in 36%. Thickening < 3 mm had a sensitivity of 87%, specificity of 48%, positive predictive value of 90% and negative predictive value of 40%. Certain correlation degree was found (r phi = 0.3, p < de 0.05) between thickening of the gallbladder wall > 5 mm and the presence of alithiasic cholecystitis, and a very slight correlation (r phi = 0.2, p < de 0.05) between thickening > 5 mm and free fluid in the abdominal cavity. CONCLUSIONS: Thickening of the gallbladder wall > 3 mm is a useful sonographic finding to confirm suspicious cases of DHF. The thickening of the gallbladder > 5 mm was just very slightly related with alithiasic cholecystitis and the presence of free fluid in the abdominal cavity, without any relationship with the most frequent laboratory data.

[Causality in cardiology: concepts in evolution]. / Causalidad en cardiología: conceptos en evolución.

This paper describes several concepts about causality from Empedocles, Aristoteles and Galeno, to Koch and Hill and the evolution of these concepts related to cardiovascular diseases. Also defines cause and risk, and the philosophical theories about scientific knowledge: inductive versus refutation analysis. On these basis, the study of cardiovascular disease's causality, especially coronary heart disease, allows us the identification of several risk factors involved in its development. However, even with the presently coronary heart disease risk charts (from Framingham and European studies) the higher probability for the development of a cardiovascular ischemic event is around 40%, establishing an important degree of uncertainty. With the improvement in molecular biology techniques, genetics have attempted to analyse several genetic polymorphisms in search of the origin of coronary heart disease. Unfortunately, less than 10% of these polymorphisms have had a positive correlation with coronary heart disease being of minor risk that those obtained for having the diagnosis of type 2 diabetes mellitus or hypercholesterolemia. On these basis, the requirement of new population research projects in which clinical and genetic risk factors are to be studied for the appropriate understanding of the causality process of cardiovascular diseases must be a worldwide priority.

BNP and congestive heart failure.

Brain natriuretic peptide (BNP), a peptide hormone secreted chiefly by ventricular myocytes, plays a key role in volume homeostasis. The plasma concentration of BNP is raised in various pathological states, especially heart failure. Many studies suggest that measurement of plasma BNP has clinical utility for excluding a diagnosis of heart failure in patients with dyspnea or fluid retention and for providing prognostic information in those with heart failure or other cardiac disease. It may also be of value in identifying patients after myocardial infarction in whom further assessment of cardiac function is likely to be worthwhile. Preliminary evidence suggests that measuring the plasma concentration of BNP may be useful in fine tuning therapy for heart failure. Artificially raising the circulating levels of BNP shows considerable promise as a treatment for heart failure. With simpler assay methods now available, it is likely that many physicians will measure plasma BNP to aid them in the diagnosis, risk stratification, and monitoring of their patients with heart failure or other cardiac dysfunction.