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From Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Co (J.W.N., H.E.H., D.M.B.), Ann Arbor, Mich; San Diego Endocrine and Medical Clinic (S.R.W.), San Diego, Calif; Chicago Center for Clinical Research (M.H.D.), Chicago, Ill; University of Cincinnati, Lipid Research Clinic (D.L.S.), Cincinnati, Ohio; Diabetes and Glandular Research Clinic (S.L.S.), San Antonio, Tex; Lipid Research Center (P.-J.L.), St Foy, Quebec, Canada; and Baylor College of Medicine (P.H.J.), Houston, Tex.
Abstract This 6-week, double-blind clinical trial evaluated lipid parameter responses to different dosages of atorvastatin in patients with primary hypercholesterolemia. Atorvastatin is a new 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor under development. After completing an 8-week placebo-baseline dietary phase, 81 patients were randomly assigned to receive either placebo or 2.5, 5, 10, 20, 40, or 80 mg atorvastatin once daily for 6 weeks. Plasma LDL cholesterol reductions from baseline were dose related, with 25% to 61% reduction from the minimum dose to the maximum dose of 80 mg atorvastatin once a day. Plasma total cholesterol and apo B reductions were also dose related. Previously, reductions in LDL cholesterol of the magnitude observed in this study have been seen only with combination drug therapy. In this study, atorvastatin was well tolerated by hyperlipidemic patients, had an acceptable safety profile, and provided greater reduction in cholesterol than other previously reported HMG-CoA reductase inhibitors.
Key Words: atorvastatin coronary disease LDL cholesterol hydroxymethylglutaryl CoA reductase hypercholesterolemia
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