Comparison of the efficacy of atorvastatin versus cerivastatin in primary hypercholesterolemia

This 6-week Prospective, Randomized, Open-label Blinded End point (PROBE) s tudy conducted at 12 sites in the United States compared the efficacy and s afety of atorvastatin with cerivastatin. In all, 215 hypercholesterolemic p atients (low-density lipoprotein [LDL) cholesterol greater than or equal to 160 mg/dl [4.14 mmol/L]; triglycerides less than or equal to 400 mg/dl [4. 52 mmol/L]) were randomized to receive either atorvastatin 10 mg once daily (n = 108) or cerivastatin 0.3 mg once daily (n = 107). Efficacy was assess ed by measuring changes from baseline in LDL cholesterol, total cholesterol , high-density lipoprotein cholesterol, apolipoprotein B, and triglycerides . Atorvastatin produced significantly greater (p <0.0001) reductions from b aseline to week 6 in LDL cholesterol (37.7% vs 30.2%), total cholesterol (2 7.5% vs 22.2%), and apolipoprotein B (28.6% vs 21.2%), and a significantly greater (p <0.05) increase from baseline to week 6 in high-density lipoprot ein cholesterol (6.8% vs 4.3%) than cerivastatin. Atorvastatin treatment wa s also associated with a greater percent decrease from baseline to week 6 i n triglycerides, with a trend toward statistical significance (p = 0.0982). The percentage of patients that achieved the National Cholesterol Educatio n Program LDL cholesterol goal was greater for those receiving atorvastatin (73%) than for those receiving cerivastatin (66%). The proportion of patie nts experiencing drug-attributable adverse events, which were mostly mild t o moderate and related to the digestive system, was significantly less (p < 0.05) with atorvastatin (5%) than with cerivastatin (14%) treatment. In con clusion, atorvastatin (10 mg/day) is more effective at lowering LDL cholest erol in hypercholesterolemic patients than cerivastatin (0.3 mg/day). Both atorvastatin and cerivastatin are well tolerated, with safety profiles simi lar to other members of the statin class. (C) 2001 by Excerpts Medica, Inc.