Efetividade e segurança dos fibratos no diabetes mellitus tipo 2: protocolo de revisão sistemática

Abstract

Introduction: The type 2 diabetes mellitus is a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both. Type 2 diabetes is the predominant form of disease, accounting for 90% of cases globally. The cardiovascular disease (CVD) is the main cause of morbidity and mortality in people with type 2 diabetes and correction of diabetic dyslipidemia might be the most important factor in reducing cardiac risk. Dyslipidemia in patients with T2DM is characterized by high triglyceride levels, low HDL-cholesterol levels, and a preponderance of small, dense, LDL-cholesterol particles. Although the statins have been shown to significantly reduce LDL-cholesterol levels, they do not specifically address the high triglyceride levels and low HDL-cholesterol levels observed in diabetic patients, both of which have been shown to be independent predictors for occurrence of adverse cardiovascular events. The fibrates are lipid-lowering medications and their major effects are to lower serum triglycerides and to raise HDL-cholesterol concentrations. Although the fibrates favorably affect two of the fundamental abnormalities of diabetic dyslipidemia, the net of CVD effects of this class of drugs remain uncertain. A systematic review of the literature is obligatory to define how effective and safe is the fibrates for the cardiovascular disease prevention in type 2 diabetes mellitus. Objective: To assess the effects of fibrates on people with type 2 diabetes mellitus. Systematic review with Cochrane methodology. Search strategy: Databases MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), LILACS, databases of ongoing trials, hand searched reference lists of published articles and conference meetings. Pharmaceutical companies and authors of published articles were contacted. There was no language restriction. Selection criteria: Randomized controlled trials (RCT) of placebo-controlled or active comparator studies of fibrates in adults with type 2 diabetes mellitus. Data collection & analysis: Data abstraction and quality assessment was performed independently by three investigators according to predetermined criteria and the results were compared to determine the degree of agreement. Quality evaluation was done using the criteria of methodological quality described in Cochrane Handbook. Continuous outcome measures were pooled using weighted mean differences (WMD). Dichotomous outcome measures were pooled using random effects model and results were expressed as relative risks (RR).

Objetivos: Avaliar a efetividade e segurança dos fibratos na prevenção de eventos cardiovasculares e mortalidade no DM 2. Métodos: Revisão sistemática utilizando a metodologia da Colaboração Cochrane. A Estratégia de Busca será realizada nas bases de dados científicas do MEDLINE, EMBASE, CENTRAL e LILACS. A busca manual será realizada em anais de congressos, listas de referências de artigos publicados, contato com companhias farmacêuticas e autores de artigos publicados. Não haverá restrição de idioma. Serão incluídos ensaios clínicos randomizados sobre o uso de fibratos em diabéticos tipo 2 adultos, controlados por placebo, associados ou não a co-intervenções. Serão avaliados os desfechos de mortalidade e morbidade cardiovasculares, eventos adversos, controle glicêmico, mudanças do perfil lipídico, surgimento de albuminúria, necessidade de laserterapia para retinopatia diabética, qualidade de vida e custos. Os resultados serão expressos como riscos relativos (RR) e diferenças de médias ponderadas (DMP). Será utilizado o modelo de efeito randômico. A extração de dados e avaliação de qualidade serão feitas independentemente por três investigadores, de acordo com critérios previamente determinados e os resultados serão comparados para determinação do grau de concordância. A avaliação de qualidade seguirá os critérios do Cochrane Handbook.