Author + information
- Received January 25, 1995
- Revision received May 26, 1995
- Accepted June 2, 1995
- Published online November 1, 1995.
- Bertram Pitt, MD, FACCa,1,*,
- G.B. John Mancini, MD, FACCa,*,1,
- Stephen G. Ellis, MD, FACCa,†,
- Howard S. Rosman, MD, FACCa,‡,
- Jong-Soon Park, PhDa,§,
- Mark E. Mcgovern, MD, FACCa,§,
- The PLAC I Investigatorsa
- ↵*Address for correspondence:Dr. Bertram Pitt, University of Michigan Hospital, Division of Cardiology, Taubman Center 3910-0366, 1500 East Medical Center Drive, Ann Arbor, Michigan 48109-0366.
Objectives. This study was designed to evaluate the effect of pravastatin on progression of coronary atherosclerosis and ischemic events in patients with coronary artery disease and mild to moderate hyperlipidemia.
Background. Few clinical trial data support the use of lipid-lowering therapy in patients with coronary artery disease and mild to moderate elevations in cholesterol levels.
Methods. Four hundred eight patients (mean age 57 years) with coronary artery disease and low density lipoprotein (LDL) cholesterol ≥130 mg/dl (3.36 mmol/liter) but <190 mg/dl ([4.91 mmol/liter]) despite diet were randomized in a 3-year study to receive pravastatin or placebo. Atherosclerosis progression was evaluated by quantitative coronary arteriography.
Results. Baseline mean LDL cholesterol was 164 mg/dl (4.24 mmol/liter). Pravastatin decreased total and LDL cholesterol and triglyceride levels by 19%, 28% and 8%, respectively, and increased high density lipoprotein cholesterol by 7% (p ≤ 0.001 vs. placebo for all lipid variables). Progression of atherosclerosis was reduced by 40% for minimal vessel diameter (p = 0.04), particularly in lesions <50% stenosis at baseline. There was a consistent although not statistically significant effect on mean diameter and percent diameter stenosis. There were also fewer new lesions in those assigned pravastatin (p ≤ 0.03). Myocardial infarction was reduced during active treatment (8 in the pravastatin group, 17 in the placebo group; log-rank test, p ≤ 0.05; 60% risk reduction), with the benefit beginning to emerge after 1 year.
Conclusions. In patients with coronary artery disease and mild to moderate cholesterol elevations, pravastatin reduces progression of coronary atherosclerosis and myocardial infarction. The time course of event reduction increases the potential for a relatively rapid decrease in the clinical manifestations of coronary artery disease with lipid lowering.
↵1 Drs. Pitt and Mancini have served as consultants to Bristol-Myers Squibb, Princeton, New Jersey.
This study was supported by a grant from the Bristol-Myers Squibb Pharmaceutical Research Institute, Princeton, New Jersey. It was presented in part at the 43rd Annual Scientific Session of the American College of Cardiology, Atlanta, Georgia, March 1994. A list of the PLAC I Investigators appears in reference 1.
- Received January 25, 1995.
- Revision received May 26, 1995.
- Accepted June 2, 1995.
- American College of Cardiology