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16-Year Mortality Follow-up of the Bezafibrate Infarction Prevention Trial

Ilan Goldenberg, MD; Valentina Boyko, MA; Alexander Tennenbaum, MD, PhD; David Tanne, MD; Solomon Behar, MD; Victor Guetta, MD

Arch Intern Med. 2009;169(5):508-514.

Background  Major randomized trials of fibrate therapy demonstrate an inverse relationship between on-treatment high-density lipoprotein cholesterol (HDL-C) increments and clinical outcome. We hypothesized that the degree of HDL-C response to bezafibrate is independently associated with subsequent long-term mortality.

Methods  The risk of death at 16 years of follow-up among 3026 patients with coronary heart disease allocated to the original bezafibrate (n = 1509) and placebo (n = 1517) arms of the Bezafibrate Infarction Prevention (BIP) trial was related to HDL-C response to bezafibrate therapy, categorized as upper-tertile (>8 mg/dL) or lower-tertile (8 mg/dL) on-treatment HDL-C change.

Results  Multivariate analysis demonstrated that patients allocated to bezafibrate therapy experienced a significant 11% reduction (P = .06) in the risk of long-term mortality compared with placebo-allocated patients. Mortality reduction among bezafibrate-allocated patients was related to a significant 22% (P = .008) reduction in the risk of death in patients with an upper-tertile HDL-C response to therapy, whereas among patients with a lower HDL-C response, the risk of death was similar to that of the placebo group (hazard ratio, 0.95; P = .43). Accordingly, the cumulative probability of death at 16 years was significantly lower among bezafibrate-allocated patients with an upper-tertile HDL-C response (32.1%) compared with the placebo group (37.9%; P = .02), whereas patients with a lower HDL-C response to treatment displayed a mortality rate (36.8%) similar to the placebo group (P = .57).

Conclusion  Our findings suggest that HDL-C level–raising therapy with bezafibrate is associated with long-term mortality reduction that may be related to the degree of HDL-C response to treatment.

Author Affiliations: Heart Institute (Drs Goldenberg, Behar, and Guetta), Neufeld Cardiac Research Institute (Drs Goldenberg and Behar and Ms Boyko), Cardiac Rehabilitation Institute (Dr Tennenbaum), and Department of Neurology Stroke Unit (Dr Tanne), Sheba Medical Center, Tel Hashomer, Israel.

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