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Alexander Tenenbaum, MD, PhD; Michael Motro, MD; Enrique Z. Fisman, MD; David Tanne, MD; Valentina Boyko, MS; Solomon Behar, MD

Arch Intern Med. 2005;165:1154-1160.

Background  A consistent relationship between metabolic syndrome (MS) and myocardial infarction (MI) has been demonstrated. We evaluated the effect of bezafibrate retard, a fibric acid derivative, on the incidence of MI in patients with MS enrolled in the Bezafibrate Infarction Prevention (BIP) study.

Methods  Patients who displayed at least 3 of the following 5 risk factors were considered to have MS: (1) a fasting glucose level of 110 mg/dL (6.11 mmol/L); (2) a triglyceride level of 150 mg/dL (1.70 mmol/L); (3) a high-density lipoprotein cholesterol level less than 40 mg/dL (<1.04 mmol/L) in men or less than 50 mg/dL (<1.30 mmol/L) in women; (4) a systolic blood pressure of 130 mm Hg or diastolic blood pressure of 85 mm Hg; and (5) a body mass index of 28.0 kg/m². The study sample for this post hoc subgroup analyses comprised 1470 patients aged 42 to 74 years. The patients received either 400 mg of bezafibrate retard (740 patients) or placebo (730 patients) once a day. The mean follow-up period was 6.2 years for events and 8.1 years for mortality data.

Results  New MI was recorded in 193 patients: 82 (11.1%) of the 740 patients in the bezafibrate group vs 111 (15.2%) of the 730 patients in the placebo group (P = .02). Bezafibrate was associated with a reduced risk of any MI and nonfatal MI with hazard ratios (HRs) of 0.71 (95% confidence interval [CI], 0.54-0.95) and 0.67 (95% CI, 0.49-0.91), respectively. The cardiac mortality risk tended to be lower in patients taking bezafibrate (HR, 0.74; 95% CI, 0.54-1.03). In 575 patients with augmented features of MS (4-5 risk factors), the remarkable strengthening of cardiac mortality reduction when taking bezafibrate (HR, 0.44; 95% CI, 0.25-0.80) should be noted.

Conclusion  Bezafibrate reduces the incidence of MI in patients with MS during long-term follow-up.

Author Affiliations: Cardiac Rehabilitation Institute (Drs Tenenbaum, Motro, and Fisman) and Bezafibrate Infarction Prevention Study Coordinating Center (Drs Tanne and Behar and Ms Boyko), Neufeld Cardiac Research Institute, Chaim Sheba Medical Center, Tel-Hashomer, Israel, affiliated with the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.

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