This Article  • References  • Full text PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Contact me when this article is cited  Related Content  • Similar articles in this journal  Social Bookmarking   What's this?

Results of 6 Years of Post-Trial Follow-up

The Lipid Research Clinics Investigators

Arch Intern Med. 1992;152(7):1399-1410.

Abstract
Background.—
Participants in the Lipid Research Clinics Coronary Primary Prevention Trial, a randomized, cholesterol-lowering trial comparing cholestyramine (N = 1907) vs placebo (N = 1899) treatment in 35- and 59-year-old asymptomatic hypercholesterolemic men, conducted between 1973 and 1983, were followed up annually from 1985 until 1989. Post-trial treatment was not provided.

Methods.—
Eleven predefined hypotheses pertaining to possible benefits and adverse effects of in-trial cholestyramine treatment were tested by standard statistical comparisons of the two original Coronary Primary Prevention Trial treatment groups (cholestyramine and placebo).

Results.—
Similar increasing proportions of cholestyramine and placebo used cholesterol-lowering drugs post-trial. After 13.4 years of in-trial plus post-trial followup, there were 13 (143 vs 156) fewer deaths in the cholestyramine group than in the placebo group. Although not statistically significant, the mortality hazard ratio (0.89) was similar to that in other cholesterol-lowering trials. This trend, a result of reduced coronary heart disease mortality, occurred despite a post-trial narrowing of the in-trial cholestyramine-placebo difference in coronary heart disease incidence from 32 (155 vs 187) to 16 (268 vs 284). The cholestyramine and placebo groups had similar 13.4-year mortality rates from cancer, other medical causes, and trauma and similar cancer incidence rates. However, 13.4-year incidences of benign colorectal tumors (50 vs 34), cancer of the buccal cavity and pharynx (eight vs two), gallbladder disease (68 vs 53), and gallbladder surgery (58 vs 40) were nonsignificantly increased in the cholestyramine group.

Conclusion.—
Overall, 6 years of post-Coronary Primary Prevention Trial follow-up have not provided conclusive evidence of benefit or long-term toxicity of cholestyramine treatment beyond that evident at the cessation of the trial.

(Arch Intern Med. 1992;152:1399-1410)

Author Affiliations
From the Lipid Metabolism-Atherogenesis Branch, Division of Heart and Vascular Diseases, National Heart, Lung, and Blood Institute, Bethesda, Md.

Footnotes
Accepted for publication February 21, 1992.

Reprint requests to the Lipid Metabolism-Atherogenesis Branch, Division of Heart and Vascular Diseases, National Heart, Lung, and Blood Institute, Federal Bldg, Room 401, Bethesda, MD 20892 (Dr Rifkind).

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Efficacy and Safety of Plant Stanols and Sterols in the Management of Blood Cholesterol Levels
Katan et al.
Mayo Clin Proc. 2003;78:965-978.
ABSTRACT  

Donald Sharp Fredrickson, MD: 1924-2002
Gotto
Circulation 2003;107:1714-1716.
FULL TEXT  

Donald S. Fredrickson, MD: 1924-2002
Gotto
Arterioscler. Thromb. Vasc. Bio. 2002;22:1506-1508.
FULL TEXT  

3-Hydroxy-3-Methylglutaryl Coenzyme A Reductase Inhibitors and the Risk of Cancer: A Nested Case-Control Study
Blais et al.
Arch Intern Med 2000;160:2363-2368.
ABSTRACT | FULL TEXT  

Effective Lipid Modification by Partial Ileal Bypass Reduced Long-term Coronary Heart Disease Mortality and Morbidity: Five-Year Posttrial Follow-up Report From the POSCH
Buchwald et al.
Arch Intern Med 1998;158:1253-1261.
ABSTRACT | FULL TEXT  

The number needed to treat: a clinically useful nomogram in its proper context
Chatellier et al.
BMJ 1996;312:426-429.
FULL TEXT  

Carcinogenicity of Lipid-Lowering Drugs
Newman and Hulley
JAMA 1996;275:55-60.
ABSTRACT  

Efficacy of Low-Dose Cholesterol-Lowering Drug Therapy in Men With Moderate Hypercholesterolemia
Denke and Grundy
Arch Intern Med 1995;155:393-399.
ABSTRACT  

Serum Carotenoids and Coronary Heart Disease: The Lipid Research Clinics Coronary Primary Prevention Trial and Follow-up Study
Morris et al.
JAMA 1994;272:1439-1441.
ABSTRACT  

Assessing possible hazards of reducing serum cholesterol
Law et al.
BMJ 1994;308:373-379.
ABSTRACT | FULL TEXT  

Primary Prevention of Coronary Heart Disease With Drug Therapy: Safety and Total Mortality Issues
Grundy
Arch Intern Med 1992;152:1369-1371.
ABSTRACT