Efficacy and safety of cerivastatin for type 2 diabetes and hypercholesterolaemia

Background The prevalence of coronary heart disease (CHD) is markedly incre ased in diabetic patients compared with non-diabetic individuals, and its p rognosis is less good. Serum total and low-density lipoprotein (LDL) choles terol concentrations have been shown to be powerful predictors of CHD morbi dity and mortality in patients with type 2 diabetes. The available data sug gest that the target cholesterol concentration in patients with diabetes sh ould be similar to that in non-diabetic individuals with a previous myocard ial infarction. This led us to investigate the efficacy, tolerability and s afety of a new, highly potent statin, cerivastatin, in diabetic hyperlipida emia. Methods This was a multinational, multicentre, double-blind, randomized stu dy in type 2 diabetic patients with hypercholesterolaemia (LDL cholesterol > 3.35 mmol/l; triglycerides < 4.56 mmol/l). Eligible patients were randoml y assigned to groups to receive cerivastatin 0.1 mg or 0.3 mg or placebo in a ratio of 2:2:1 for 12 weeks. They were monitored in the clinic every 4 w eeks. Results Of the 453 patients screened, 265 were allocated to the study group s, Fifty-one received placebo and 107 patients were assigned to each active treatment group (0.1 mg and 0.3 mg cerivastatin). At the close of the stud y, total cholesterol had decreased by 13.7% and 23.5%, LDL cholesterol decr eased by 20.2% and 33.8%, and triglyceride concentrations decreased by 3.9% and 12.3% in the cerivastatin 0.1 mg and 0.3 mg groups, respectively, Ther e was no significant difference between the groups in haemoglobin A(1c), ad verse events or increases in liver and muscle enzymes during the study peri od. Conclusions Hypercholesterolaemic patients with type 2 diabetes had a signi ficant reduction in LDL cholesterol and total cholesterol concentrations af ter cerivastatin treatment once daily. The dose of 0.3 mg cerivastatin is e ffective in diabetic hypercholesterolaemia, with cc-reduction of triglyceri de concentrations. The effect of cerivastatin on coronary morbidity and mor tality is currently being investigated in clinical trials. (C) 1999 Lippinc ott Williams & Wilkins.