EFFICACY AND SAFETY OF PRAVASTATIN IN THE TREATMENT OF PATIENTS WITH TYPE-I OR TYPE-II DIABETES-MELLITUS AND HYPERCHOLESTEROLEMIA

PURPOSE: Patients with type I and type II diabetes mellitus have an in creased risk of coronary heart disease. In many diabetics, hypercholes terolemia is present and further exacerbates this risk. We investigate d the efficacy and safety of pravastatin in the treatment of patients with type I or type II diabetes mellitus and hypercholesterolemia. PAT IENTS AND METHODS: In this 24-week, multicenter, double-blind, placebo -controlled study, 94 patients (45 men, 49 women), 18 to 70 years of a ge, with type I or type II diabetes mellitus and hypercholesterolemia (fasting plasma low-density lipoprotein cholesterol [LDL-C] levels > 1 50 mg/dL and above the 75th percentile for the US population by age an d gender) were randomized to receive pravastatin 20 mg hs or matching placebo. Two patients were randomized to treatment with drug for every 1 randomized to placebo. The dose could be doubled after 10 weeks, an d cholestyramine or colestipol could be added after 18 weeks, as neede d, to attempt to lower the LDL-C levels to below the 50th percentile f or the US population. RESULTS: Significant reductions in LDL-C (-27.6% ), total cholesterol (-22.1%), very-low-density lipoprotein cholestero l (-22.6%), and triglycerides (-12.8%) (P less than or equal to 0.001 versus placebo for all reductions), and significant increases in high- density lipoprotein cholesterol (4.4%) (P less than or equal to 0.05 v ersus placebo) were noted in the pravastatin treatment group (average dose 29.5 mg) at 16 weeks. The beneficial lipid-lowering effects of pr avastatin were maintained throughout the 24 weeks of the study. Pravas tatin was well tolerated, and the frequency of side effects was simila r in the pravastatin and placebo groups. No clinically significant cha nges in the control of diabetes, as assessed by fasting blood glucose levels and glycosylated hemoglobin measurements, were seen during this study. CONCLUSION: The results of this study demonstrate that pravast atin is well tolerated and effective in lowering total cholesterol and LDL-C in patients with type I or type II diabetes mellitus and hyperc holesterolemia.