Bezafibrate retard in type II diabetic patients: effects on hemostasis and glucose homeostasis

A double-blind, placebo-controlled trial assessed the effect of a slow-release formulation of bezafibrate (Bezalip Mono, 400 mg daily for 3 months) on lipid profile, glucose homeostasis, platelet function, and plasma fibrinogen concentration in non-insulin-dependent (type II) diabetics. Twenty-four patients completed the trial. There was a significant improvement in the cholesterol (p less than 0.02), triglyceride (p less than 0.01), and nonesterified fatty acid (p less than 0.05) concentrations and in the fasting blood glucose (p less than 0.03) and glycosylated hemoglobin (p less than 0.01) levels of those (n = 11) who received the active preparation but not in those (n = 13) who received placebo. Treatment, but not placebo, also resulted in a significant (p less than 0.01) fall in plasma fibrinogen concentration and a trend towards inhibition of platelet aggregation. Bezafibrate was well tolerated; only one patient (not included in the analysis of results) withdrew from the trial possibly because of side effects of the drug. A larger study is needed to establish whether bezafibrate can reduce nonlipid risk factors (e.g., plasma fibrinogen concentration, glucose intolerance, and hyperinsulinemia) in normo- and hyperlipidemic subjects.