The efficacy and safety of bezafibrate were evaluated in 83 patients with type Ila, IIb, or 1V hyperlipoproteinemia. Following a 12- to 14-week placebo period on a coronary-prudent diet (Period 1), patients were assigned randomly to receive either bezafibrate 600 mg/day or placebo, plus diet in a double blind, 12-week treatment period (Period 2). The return of lipid and lipoprotein levels toward baseline was evaluated in a subsequent 8-week period on placebo plus diet (Period 3). In patients with type IIa hyperlipoproteinemia, bezafibrate significantly lowered total (14.6%, P < 0.001) and LDL-cholesterol (16.4%, P < 0.001) and total (29.9%, P < 0.001) and VLDL-triglyceride (44.0%, P < 0.001) and significantly increased HDL cholesterol (9.5%, P < 0.001). In patients with type IIb, bezafibrate had a qualitatively similar effect to that seen in type IIa on each of these lipoproteins, but the sample size was too small for statistical evaluation. In patients with type IV, bezafibrate lowered total (48.3%, P < 0.01) and VLDL-triglyceride (57.7%, P < 0.001) and VLDL-cholesterol (56.8%, P < 0.001) and increased HDL-cholesterol (16.6%, P < 0.05). All values returned toward baseline during Period 3. Only two bezafibrate patients experienced adverse events that were considered definitely treatment related; one was dropped from the study because of elevations in SGOT and SGPT, 1.5- and 4-times the upper limit of normal, respectively. For other laboratory parameters, trends upward or downward were small and of doubtful clinical significance. Bezafibrate appears to be effective and safe for modifying lipid and lipoprotein levels in patients with types Ila, IIb and IV hyperlipoproteinemia.
- Fibric acid analog