A BRIEF REVIEW PAPER OF THE EFFICACY AND SAFETY OF ATORVASTATIN IN EARLY CLINICAL-TRIALS

Preclinical and clinical data on atorvastatin, a new 3-hydroxy-3-methy lglutaryl coenzyme A (HMG-CoA) reductase inhibitor, indicate that it h as superior activity in treating a variety of dyslipidemic disorders c haracterized by elevations in low-density lipoprotein cholesterol (LDL -C) and/or triglycerides. Results for patients randomized in early eff icacy and safety studies were combined in one database and analyzed. T his analysis included a total of 231 atorvastatin-treated patients (13 1 with hypercholesterolemia (HC), 63 with combined hyperlipidemia (CH) , 36 with hypertriglyceridemia (HTG), and 1 with hyperchylomicronemia (Fredrickson Type V)). Patients were treated with a cholesterol-loweri ng diet (National Institutes of Health National Cholesterol Education Program Step 1 diet or a more rigorous diet) and either 2.5, 5, 10, 20 , 40, or 80 mg/day of atorvastatin or placebo, Efficacy was based on p ercent change from baseline in total cholesterol, total triglycerides, LDL-C, very low-density lipoprotein cholesterol (VLDL-C), high-densit y lipoprotein cholesterol (HDL-C), apolipoprotein B (ape B), and non-H DL-C/HDL-C. Safety was assessed in all randomized patients. Atorvastat in seemed to preferentially lower those lipid and lipoprotein componen t(s) most elevated within each dyslipidemic state: LDL-C in patients w ith HC; triglycerides and VLDL-C in patients with HTG, or all 3 in pat ients with CH. Atorvastatin was well-tolerated with a safety profile s imilar to other drugs in its class. (C) 1997 Elsevier Science Ireland Ltd.