This study investigated the effects of pravastatin and simvastatin in hyper cholesterolemic patients with type 2 diabetes mellitus. Pravastatin and simvastadin were administered at the initial dosages approved in Japan (10 mg/d and 5 mg/d, respectively) to 40 patients using a crossover design. Pravastatin and simvastatin significantly reduced serum total cholesterol (TC) levels and low-density Lipoprotein cholesterol (LDL-C) levels. However, the percentage reduction in TC levels was significantly greater with simvastatin than with pravastatin (-19 +/- 7% vs -15 +/- 9%, respectively; P < 0.05). Similarly, the percentage reduction in LDL-C levels was significantly greater with simvastatin than with pravastatin (-30 +/- 11% vs -22 +/- 12%, respectively; P < 0.001). The percentage of patients who attained the therapeutic goal of LDL-C less than or equal to 120 mg/dL, and TC less than or equal to 200 mg/dL with simvastatin was significantly greater than that with pravastatin (46% vs 21% and 23% vs 13%, respectively; P < 0.05). Neither pravastatin nor simvastatin had any effect on high-density lipoprotein cholesterol, triglycerides, fasting plasma glucose, or glycosylated hemoglobin A(1c). No abnormal laboratory test results or adverse events were reported during treatment with either drug. Because both pravastatin and simvastatin significantly reduced TC and LDL-C levels without influencing control of blood glucose level, these drugs, especially simvastatin, might be safe and useful for treating hyperlipidemic patients with type 2 diabetes mellitus.