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Cholesterol Lowering in the ElderlyResults of the Cholesterol Reduction in Seniors Program (CRISP) Pilot Study
John C LaRosa, MD;
William Applegate, MD;
John R. Crouse III, MD;
Donald B. Hunninghake, MD;
Richard Grimm, MD, PhD;
Robert Knopp, MD;
John H. Eckfeldt, MD, PhD;
Clarence E. Davis, PhD;
David J. Gordon, MD, PhD
Arch Intern Med. 1994;154(5):529-539.
Abstract
Background
Total and lipoprotein cholesterol levels continue to be predictors of coronary heart disease risk in men and women over 65 years old. Cholesterol-lowering trials, however, while sometimes including such subjects, have not concentrated on this age group. The Cholesterol Reduction in Seniors Program was a five-center pilot study to assess feasibility of recruitment and efficacy of cholesterol lowering in this age group.
Methods
The study was a randomized, double-masked clinical trial with placebo, 20-mg lovastatin, and 40-mg lovastatin arms. Major efforts were made to recruit women and minorities. Participants were followed up for 1 year on a cholesterollowering diet plus placebo or study drug. End points were changes in blood lipid levels. Data on other blood chemistry values, as well as quality-of-life measures and coronary heart disease morbidity and mortality, were also collected.
Results
Four hundred thirty-one subjects with low-density lipoprotein cholesterol levels greater than 4.1 and less than 5.7 mmol/L (159 and 221 mg/dL) were randomized, of whom 71% were women and 21% were African Americans; the mean age was 71 years. In the 20- and 40-mg lovastatin groups, total cholesterol levels fell 17% and 20%; lowdensity lipoprotein cholesterol levels fell 24% and 28%; triglyceride levels fell 4.4% and 9.9%, respectively. High-density lipoprotein cholesterol levels rose 7.0% and 9.0%, respectively. No changes were observed in the placebo group. Gender, race, and age did not significantly affect responses. Coronary heart disease morbidity and mortality data were collected but not analyzed for this study.
Conclusion
Older subjects of both genders and a variety of racial and ethnic groups can be successfully recruited into a cholesterol-lowering trial. Lovastatin has effects similar to those reported in younger subjects in previous controlled trials. There is little advantage to the higher lovastatin daily dose. Side effects were remarkably low in all groups.
(Arch Intern Med. 1994;154:529-539)
Author Affiliations
From Department of Medicine, George Washington University Medical Center, Washington, DC (Dr LaRosa); Department of Preventive Medicine, University of Tennessee, Memphis (Dr Applegate); Department of Internal Medicine and Endocrinology, Bowman Gray School of Medicine, Winston-Salem, NC (Dr Crouse); Departments of Medicine and Pharmacology (Dr Hunninghake), Internal Medicine (Dr Grimm), Laboratory Medicine and Pathology (Dr Eckfeldt), University of Minnesota, Minneapolis; Department of Medicine, University of Washington, Seattle (Dr Knopp); Department of Biostatistics, University of North Carolina at Chapel Hill (Dr Davis); and National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Md (Dr Gordon).
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