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J Am Coll Cardiol, 2008; 51:459-465, doi:10.1016/j.jacc.2007.09.048
© 2008 by the American College of Cardiology Foundation
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CLINICAL RESEARCH: LIPID-LOWERING THERAPY

Secondary Prevention With Bezafibrate Therapy for the Treatment of Dyslipidemia

An Extended Follow-Up of the BIP Trial

Ilan Goldenberg, MD*,{dagger}, Michal Benderly, PhD{dagger}, Uri Goldbourt, PhD{dagger},{ddagger},* for the BIP Study Group

* Heart Institute, Sheba Medical Center, Tel Hashomer, Israel
{dagger} Neufeld Cardiac Research Institute, Sheba Medical Center, Tel Hashomer, Israel
{ddagger} Division of Epidemiology and Preventive Medicine, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.

Manuscript received August 6, 2007; revised manuscript received September 10, 2007, accepted September 17, 2007.

* Reprint requests and correspondence: Dr. Uri Goldbourt, Neufeld Cardiac Research Institute, Sheba Medical Center, Tel Hashomer 52621, Israel. (Email: goldbu1{at}post.tau.ac.il).

Objectives: This study was designed to evaluate the long-term cardiovascular benefit of bezafibrate therapy in coronary heart disease patients enrolled in the BIP (Bezafibrate Infarction Prevention) trial.

Background: The BIP trial yielded a nonsignificant 7.3% reduction in the rate of major cardiac events after a mean follow-up period of 6.2 years, possibly owing to an increasing unbalanced usage of nonstudy lipid-lowering drugs (LLDs) during the course of the trial.

Methods: The adjusted risk for the combined end point of cardiac death or nonfatal myocardial infarction during an extended mean 8.2-year follow-up period of the BIP trial was assessed in 3,090 patients allocated to the original bezafibrate (n = 1,548) and placebo (n = 1,542) groups of the trial.

Results: During the extended follow-up period, nonstudy LLDs were administered to a significantly greater proportion of placebo-allocated patients (57%) than bezafibrate-allocated patients (53%; p = 0.02). Interaction-term analysis demonstrated that the benefit of bezafibrate therapy was pronounced (18% risk reduction; p = 0.03) without or before treatment with nonstudy LLDs initiated during follow-up and attenuated (hazard ratio 1.05; p = 0.85) after therapy with nonstudy LLDs initiated during the observation period. Consistent with these findings, treatment with bezafibrate was shown to be associated with a significant 17% risk reduction (p = 0.03) when study patients were censored from the analysis upon initiation of therapy with nonstudy LLDs.

Conclusions: The data demonstrate that bezafibrate therapy in the BIP trial was associated with significant long-term cardiovascular protection that was attenuated by an unbalanced usage of nonstudy LLDs during the course of the trial.

Abbreviations and Acronyms
  AP = angina pectoris
  BMI = body mass index
  CHD = coronary heart disease
  HDL-C = high-density lipoprotein cholesterol
  LDL-C = low-density lipoprotein cholesterol
  LLD = lipid lowering drugs
  MI = myocardial infarction




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