Abstract
BackgroundRecent data support the renewed interest in hypertriglyceridemia as a possible important therapeutic target for cardiovascular risk reduction. This study was designed to address the question of all-cause mortality during extended follow-up of the BIP trial in patients stratified by baseline triglyceride levels.MethodsIn the BIP trial 3090 patients with proven coronary artery disease were randomized to bezafibrate 400 mg/day or placebo. All-cause mortality data after 20 years of follow-up, were obtained from the National Israeli Population Registry. Patients with hypertriglyceridemia (triglycerides ≥200 mg/dL, n = 458) were equally distributed among the study groups (15 % in both placebo and bezafibrate groups).ResultsDuring follow-up 1869 patients died (952 in placebo vs. 917 in bezafibrate group). Following multivariate adjustment allocation to bezafibrate was associated with small but significant 10 % mortality risk reduction (HR 0.90; 95 % CI 0.82–0.98, p = 0.026). Variables associated with significantly increased mortality risk were history of a past MI, NYHA class, diabetes, age, higher BMI and glucose level. In patients with hypertriglyceridemia multivariate analysis demonstrated a 25 % all-cause mortality risk reduction associated with allocation to bezafibrate (HR 0.75, CI 95 % 0.60–0.94; p = 0.012). In patients without hypertriglyceridemia bezafibrate had no significant effect on long-term mortality.ConclusionsDuring long-term follow-up bezafibrate-allocated patients experienced a modest but significant 10 % reduction in the adjusted risk of mortality. This effect of bezafibrate was more prominent among patients with baseline hypertriglyceridemia (25 % mortality risk reduction).Electronic supplementary materialThe online version of this article (doi:10.1186/s12933-016-0332-6) contains supplementary material, which is available to authorized users.
Highlights
Recent data support the renewed interest in hypertriglyceridemia as a possible important therapeutic target for cardiovascular risk reduction
During post hoc analysis of the Bezafibrate Infarction Prevention (BIP) trial we have shown that bezafibrate significantly reduced the incidence of myocardial infarction in patients with the metabolic syndrome [10]
We hypothesized that early favorable effects of bezafibrate on lipids and myocardial infarction during the original trial period could be translated in a subsequent reduction in total mortality during a longer-term observation
Summary
Recent data support the renewed interest in hypertriglyceridemia as a possible important therapeutic target for cardiovascular risk reduction. This study was designed to address the question of all-cause mortality during extended follow-up of the BIP trial in patients stratified by baseline triglyceride levels. Arbel et al Cardiovasc Diabetol (2016) 15:11 despite these favorable lipid-modifying effects, bezafibrate therapy was associated with only a non-significant trend of a reduction of the incidence of primary end point (fatal or non-fatal myocardial infarction or sudden death). A significant 39.5 % reduction in the primary end point in patients with high baseline TG (≥ 200 mg/dl) was observed. We hypothesized that early favorable effects of bezafibrate on lipids and myocardial infarction during the original trial period could be translated in a subsequent reduction in total mortality during a longer-term observation. This study was designed to address the question of mortality during extended 20-year follow-up of the BIP trial
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