A multinational study of the effects of low‐dose pravastatin in patients with non‐insulin‐dependent diabetes mellitus and hypercholesterolemia

This multinational, 16‐week, randomized, doubleblind, placebo‐controlled study evaluated the efficacy and safety of low‐dose pravastatin in 325 patients with non‐insulindependent diabetes mellitus (NIDDM) and hypercholesterolemia [serum total cholesterol concentrations of 5.2‐7.8 mmol/1 (200 to 300 mg/dl)]. Patients were randomized to receive pravastatin 10 mg or matching placebo with doubling of the dose after 8 weeks if predefined target levels for total cholesterol [(i.e., < 5.2 mmol/1 (200 mg/dl) or > 15% decrease from baseline] had not been achieved. At Week 16, pravastatin‐treated patients showed a 21.4% decrease in serum low‐density lipoprotein cholesterol (LDL‐C) and a 13.5% reduction in serum total cholesterol (TC) concentrations (p < 0.001 compared with placebo). Levels of triglycerides (TG) were reduced 9.6% during pravastatin treatment (p < 0.05 compared with placebo) while high‐density lipoprotein cholesterol (HDL‐C) levels were increased 4.4% (p =NS). Adverse events and laboratory test abnormalities were similar among patients treated with pravastatin or placebo. Glycosylated hemoglobin (HbA1C) levels remained unchanged. The results of this study demonstrate that low‐dose pravastatin is effective and well tolerated for lowering elevated cholesterol concentrations during short‐term treatment of patients with NIDDM and hypercholesterolemia.