Comparative efficacy study of atorvastatin vs. simvastatin, pravastatin, lovastatin and placebo in type 2 diabetic patients with hypercholesterolaemia

Although there is little information from primary or secondary prevention t rials on cholesterol-lowering medication in diabetic patients, the reductio n of elevated cholesterol is widely recommended for this group. The America n Diabetes Association (ADA) recommends drug therapy in diabetic patients i f low density lipoprotein (LDL)-cholesterol remains at > 130 mg/dl, or > 10 0 mg/dl in patients with macroangiopathy, after dietary intervention. When cholesterol-lowering medication is indicated, the choice of the drug must t ake into account the other lipid abnormalities that are often present and t he need to maintain optimal glycaemic control. In the present study we comp ared the efficacy and safety of the novel HMG-CoA reductase inhibitor atorv astatin at the dose of 10 mg/day with simvastatin , lovastatin and pravasta tin at doses of 10, 20 and 20 mg/day, respectively, and placebo, in type 2 diabetic patients with moderate elevation of LDL-cholesterol with or withou t elevation of triglycerides. All the quoted agents are enzyme inhibitors e ffective in lowering LDL-cholesterol in humans. The efficacy endpoints were the mean per cent changes in plasma LDL-cholesterol (primary), total chole sterol, triglycerides, and high-density lipoprotein (HDL)-cholesterol conce ntrations from baseline to the end of treatment (24 weeks). Atorvastatin at a dose of 10 mg/day produced: (1) a significant reduction in LDL-cholester ol (- 37%) in comparison with equivalent doses of simvastatin (- 26%), prav astatin (- 23%), lovastatin (- 21%), and placebo (- 1%); (2) HDL-cholestero l increases (7.4%) comparable to or greater than those obtained with simvas tatin (7.1%), pravastatin (3.2%), lovastatin (7.21%), and placebo (- 0.5%); (3) a significantly greater reduction in total cholesterol (- 29%) than th at obtained with simvastatin (- 21%), pravastain (- 16%), lovastatin (- 18% ), and placebo (1%); and (4) a significantly greater reduction in triglycer ides than that obtained with all the other drugs and placebo. In all treatm ent groups no significant variation in fibrinogen concentration was observe d. All reductase inhibitors studied had similar levels of tolerance. There were no incidents of persistent elevations of serum aminotransferases or my ositis.