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European Heart Journal Advance Access published online on May 4, 2005
European Heart Journal, doi:10.1093/eurheartj/ehi310
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European Heart Journal © The European Society of Cardiology 2005; All rights reserved
Received September 2, 2004
Revised February 17, 2005
Accepted April 7, 2005

Clinical research

Effect of bezafibrate on incidence of type 2 diabetes mellitus in obese patients

Alexander Tenenbaum 1*, Michael Motro 2, Enrique Z. Fisman 2, Yehuda Adler 2, Joseph Shemesh 2, David Tanne 3, Jonathan Leor 3, Valentina Boyko 3, Ehud Schwammenthal 2, and Solomon Behar 3

1 Cardiac Rehabilitation Institute, Chaim Sheba Medical Center, Tel-Hashomer 52621, Israel
2 Cardiac Rehabilitation Institute, Chaim Sheba Medical Center, Tel-Hashomer 52621, Israel
3 Bezafibrate Infarction Prevention Study Coordinating Center, Neufeld Cardiac Research Institute, The Chaim Sheba Medical Center, Tel-Hashomer 52621, Israel

* To whom correspondence should be addressed.
Alexander Tenenbaum, E-mail: altenen{at}post.tau.ac.il


  Abstract

Aims To assess the effect of fibric acid derivative bezafibrate on incidence of type 2 diabetes in obese patients over a median 6.3 years follow-up period.

Methods and results The study sample comprised 339 non-diabetic obese patients (body mass index ≥30.0 kg/m2) aged 42-74. Patients received either bezafibrate retard 400 mg (178 patients) or placebo (161 patients) once daily. Development of new diabetes was recorded in 98 patients: in 56 (37.0%) from the placebo group vs. 42 (27.1%) from the bezafibrate group, (P log-rank=0.01). The median time (interquartile range) until onset of new diabetes was significantly delayed in patients on bezafibrate when compared with those on placebo: 4.0 (2.1-5.0) vs. 2.0 (0.5-3.5) years, P=0.002. Multivariable analysis identified bezafibrate treatment as an independent predictor of reduced risk of new diabetes with hazard ratio (HR) 0.59 [95% confidence interval (CI) 0.39-0.91]. Other significant variables associated with future overt type 2 diabetes in obese patients were triglycerides (50 mg/dL increment) with HR 1.15 (95% CI 1.02-1.28) and fasting glucose (10 mg/dL increment) with HR 2.27 (95% CI 1.83-2.81).

Conclusion Bezafibrate, when compared with placebo, reduced the incidence and delayed the onset of type 2 diabetes in obese patients over a long-term follow-up period.

Keywords: Obesity; Diabetes mellitus; Prevention; Bezafibrate.
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