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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^_*,, Michal Benderly, PhD, Uri Goldbourt, PhD^,,_* for the BIP Study Group

^_* Heart Institute, Sheba Medical Center, Tel Hashomer, Israel
Neufeld Cardiac Research Institute, Sheba Medical Center, Tel Hashomer, Israel
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