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, double-blind, placebo-control led study evaluated the efficacy and safety of low-dose pravastatin in 325 patients with non-insulin-dependent diabetes mellitus (NIDDM) and hypercholesterolemia [serum total cholesterol concentrations of 5.2-7 .8 mmol/l (200 to 300 mg/dl)]. Patients were randomized to receive pra vastatin 10 mg or matching placebo with doubling of the dose after 8 w eeks if predefined target levels for total cholesterol [(i.e., <5.2 mm ol/l (200 mg/dl) or > 15% decrease from baseline] had not been achieve d. At Week 16, pravastatin-treated patients showed a 21.4% decrease in serum low-density lipoprotein cholesterol (LDL-C) and a 13.5% reducti on in serum total cholesterol (TC) concentrations (p < 0.001 compared with placebo). Levels of triglycerides (TG) were reduced 9.6% during p ravastatin treatment (p < 0.05 compared with placebo) while high-densi ty 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 demonstra te that low-dose pravastatin is effective and well tolerated for lower ing elevated cholesterol concentrations during short-term treatment of patients with NIDDM and hypercholesterolemia.