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Cholesterol lowering in the elderly. Results of the Cholesterol Reduction in Seniors Program (CRISP) pilot study.

AbstractBACKGROUND:
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 cholesterol-lowering 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%; low-density 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.
AuthorsJ C LaRosa, W Applegate, J R Crouse 3rd, D B Hunninghake, R Grimm, R Knopp, J H Eckfeldt, C E Davis, D J Gordon
JournalArchives of internal medicine (Arch Intern Med) Vol. 154 Issue 5 Pg. 529-39 (Mar 14 1994) ISSN: 0003-9926 [Print] United States
PMID8122946 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)
Chemical References
  • Lipids
  • Lovastatin
Topics
  • Aged
  • Combined Modality Therapy
  • Double-Blind Method
  • Feasibility Studies
  • Female
  • Humans
  • Hypercholesterolemia (blood, diet therapy, drug therapy, physiopathology)
  • Lipids (blood)
  • Lovastatin (administration & dosage, therapeutic use)
  • Male
  • Pilot Projects
  • Quality of Life
  • Treatment Outcome
  • Vision, Ocular (drug effects)

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