Pravastatin compared to bezafibrate in the treatment of dyslipidemia in insulin-treated patients with type 2 diabetes mellitus.

Background: Both HMG-CoA reductase inhibitors and fibric acid derivates are used for the treatment of dyslipidemia in Type 2 diabetes patients. The aim of this study was to compare the lipid lowering effect of 40 mg pravastatin, a HMG-CoA reductase inhibitor, and 400 mg bezafibrate, a fibric acid derivate, on serum lipids, lipoproteins and lipoprotein composition in 45 (22 men and 23 women) dyslipidemic, insulin-treated Type 2 diabetes patients.

Method: The study used a double-blind, cross-over design.

Results: Pravastatin treatment was more effective in reducing total cholesterol, LDL-cholesterol, LDL-triglycerides, LDL-ApoB and LDL/HDL-cholesterol ratio (all p<0.001 between groups) and total/HDL-cholesterol and ApoA1/LDL-ApoB ratios (both p<0.01) and always induced a decrease in LDL-cholesterol concentrations and LDL/HDL-cholesterol ratio irrespective of baseline triglyceride concentration. Bezafibrate was more effective in increasing HDL-cholesterol (p<0.01 between groups), ApoA1 lipoprotein and decreasing triglycerides (both p<0.001 between groups) but induced an increase in LDL-cholesterol concentration particularly in patients with baseline triglyceride concentrations exceeding 2.0 mmol/l. With bezafibrate treatment the LDL-cholesterol/LDL-ApoB ratio showed a tendency to rise, suggesting a change in the LDL particle composition to a less small and dense form, while pravastatin treatment induced a decrease in this ratio suggesting a change in the LDL particle to a more dense form. With pravastatin treatment a small rise in HbA(1c) was observed.

Conclusion: Pravastatin treatment is superior in lowering cholesterol-enriched lipoprotein subpopulations and improving cardiovascular risk factors. Bezafibrate is more effective in raising HDL-cholesterol and alters LDL particle composition to a more favorable form.