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(Arteriosclerosis, Thrombosis, and Vascular Biology. 1997;17:1793-1799.)
© 1997 American Heart Association, Inc.

Articles

Efficacy and Safety of a New Hydroxymethylglutaryl-Coenzyme A Reductase Inhibitor, Atorvastatin, in Patients with Combined Hyperlipidemia: Comparison with Fenofibrate

Teik C. Ooi; Therese Heinonen; Petar Alaupovic; Jean Davignon; Lawrence Leiter; Paul J. Lupien; Allan D. Sniderman; Meng H. Tan; Gerald Tremblay; Alexander Sorisky; Linda Shurzinske; ; Donald M. Black

From the Ottawa Civic Hospital, Ottawa, Ontario, Canada (T.C.O., A.S.); Parke-Davis Pharmaceutical Research Division of Warner-Lambert Company, Ann Arbor, Mich (T.H., L.S., D.M.B.); Lipid and Lipoprotein Laboratory, Oklahoma Medical Research Foundation, Oklahoma City, Okla (P.A.); Hyperlipidemia and Atherosclerosis Research Group, Clinical Research Institute of Montreal, Montreal, Quebec, Canada (J.D.); St. Michael's Health Center, Toronto, Ontario, Canada (L.L.); Centre Hospitalier de l'Universite Laval, Foy, Quebec, Canada (P.J.L.); Royal Victoria Hospital, Montreal, Quebec Canada (A.D.S.); Camp Hill Medical Centre, Halifax, Nova Scotia, Canada (M.H.T.); and Clinique des Lipides, Hôpital de Chicoutimi, Chicoutimi, Quebec, Canada (G.T.).

Correspondence and reprint requests to Teik C. Ooi, MB, Ottawa Civic Hospital, 1053 Carling Ave., Ottawa, ON K1Y 4E9, Canada.

Abstract This 24-week, randomized, open-label multicenter study evaluated the efficacy and safety of atorvastatin compared with fenofibrate in the treatment of patients with combined hyperlipidemia (CHL). Following a 6-week baseline period, 84 patients with CHL were randomly assigned to either atorvastatin treatment, 10 mg QD for 12 weeks increasing to 20 mg QD for 12 weeks, or fenofibrate treatment, 100 mg TID for 24 weeks. Changes from baseline in lipid parameters were evaluated at weeks 12 and 24. At both 10- and 20-mg doses, atorvastatin treatment resulted in significantly greater reductions in LDL cholesterol, apolipoprotein (apo) B, total cholesterol, LDL-apoB, and lipoprotein-B compared to 300-mg fenofibrate treatment (P<.05). While atorvastatin also resulted in clinically significant reductions in triglyceride, VLDL cholesterol, apoB in VLDL, triglyceride in VLDL, and apoC-III and significant increases in HDL cholesterol and apoA-I levels, fenofibrate was more effective than atorvastatin in altering all these parameters. However, by significantly affecting both the cholesterol-rich and triglyceride-rich particles, atorvastatin holds promise as a lipid-regulator able to adequately treat a broad range of patients that includes those with CHL.

Key Words: atorvastatin • combined hyperlipidemia • hydroxy-methylglutaryl coenzyme A reductase inhibitor • fenofibrate

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