EFFICACY AND SAFETY OF A NEW HYDROXYMETHYLGLUTARYL-COENZYME A REDUCTASE INHIBITOR, ATORVASTATIN, IN PATIENTS WITH COMBINED HYPERLIPIDEMIA -COMPARISON WITH FENOFIBRATE

This 24-week, randomized, open-label multicenter study evaluated the e fficacy and safety of atorvastatin compared with fenofibrate in the tr eatment of patients with combined hyperlipidemia (CHL). Following a 6- week baseline period, 84 patients with CHL were randomly assigned to e ither atorvastatin treatment, 10 mg QD for 12 weeks increasing to 20 m g QD for 12 weeks, or fenofibrate treatment, 100 mg TID for 24 weeks. Changes from baseline in lipid parameters were evaluated at weeks 12 a nd 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 incre ases in HDL cholesterol and apoA-I levels, fenofibrate was more effect ive than atorvastatin in altering all these parameters. However, by si gnificantly affecting both the cholesterol-rich and triglyceride-rich particles, atorvastatin holds promise as a lipid-regulator able to ade quately treat a broad range of patients that includes those with CHL.