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A Multicenter, Placebo-Controlled, Dose-Ranging Study of Atorvastatin

University of Iowa, Iowa City, Iowa

Anita Gmerek Fereshetian

Parke-Davis Pharmaceutical Research, Ann Arbor, Michigan

Robert H. Knopp

University of Washington, Seattle, Washington

Harold Bays

The Lipid Center, Louisville, Kentucky

Peter H. Jones

Baylor University, Houston, Texas

Thomas W. Littlejohn

Piedmont Research Associates, Winston-Salem, North Carolina

Richard McLain

Parke-Davis Pharmaceutical Research, Ann Arbor, Michigan

Donald M. Black

Parke-Davis Pharmaceutical Research, Ann Arbor, Michigan

Background: Coronary heart disease (CHD) is the number one cause of death in Western societies. Elevated levels of plasma low-density lipoprotein (LDL) cholesterol and triglycer ides (TG) increase the risk for CHD. 3-Hydroxy-3-methylglutaryl conenzyme A (HMG- CoA) reductase inhibitors effectively reduce plasma cholesterol levels in patients with hypercholesterolemia. This study assesses the safety and dose-related effects of atorvastatin calcium on lipoprotein fractions in patients with LDL cholesterol levels between 160 mg/dL (4.1 mM) and 250 mg/dL (6.5 mM) or less and TG levels of 400 mg/dL (4.5 mM) or less.

Methods and Results: Sixty-five patients were enrolled in a 6-week, randomized, placebo- controlled, parallel-group study. Patients received placebo or atorvastatin 10, 20, 40, 60, or 80 mg once daily. Adjusted mean decreases in LDL cholesterol for patients receiving ator vastatin 10, 20, 40, 60, and 80 mg were 37%, 42%, 50%, 52%, and 59%, respectively, com pared with a mean increase of 0.3% for patients receiving placebo; the differences between each of the atorvastatin dose groups and placebo were statistically significant (P = .0001). Total cholesterol, triglycerides, and apolipoprotein B were significantly reduced in atorva statin groups (P = .0001). Adverse events were similar in the placebo and atorvastatin treat ment groups. No patient had a serious adverse event or withdrew because of an adverse event during this study.

Conclusions: Atorvastatin effectively lowered plasma LDL cholesterol, triglycerides, and apoB levels in a dose-related manner. Atorvastatin was well tolerated in hyperlipidemic patients over a 6-week period.

Key Words: atorvastatin • coronary heart disease • LDL cholesterol.

Journal of Cardiovascular Pharmacology and Therapeutics, Vol. 3, No. 2, 119-123 (1998)
DOI: 10.1177/107424849800300204


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