A Review of the Clinical Trials Evidence
PEMD-96-7: Published: May 14, 1996. Publicly Released: Jun 13, 1996.
- Full Report:
Pursuant to a congressional request, GAO reviewed the evidence from clinical trials that the National Heart, Lung, and Blood Institute (NHLBI) used to develop its National Cholesterol Education Program guidelines.
GAO found that: (1) meta-analyses of trial data consistently show that cholesterol treated persons, regardless of their medical history, have significantly fewer non-fatal heart attacks than untreated persons; (2) treated persons also showed a reduction in the number of fatal heart attacks compared to the nontreated group, but the difference was not statistically significant except among those who had a history of coronary heart disease (CHD); (3) according to one trial, cholesterol treatment has not led to a reduction in deaths from all causes; (4) the increase in deaths from other causes shown in the trials occurred primarily among persons whose risk for CHD was lower, whose cholesterol was reduced less, or who used certain drugs; (5) the two trials that used newer cholesterol-lowering drugs confirmed the finding that the more cholesterol levels were lowered, the fewer coronary events occurred; (6) previous trials were not representative of the population at large, since they focused mainly on middle-aged white men at high risk for CHD; (7) several clinical trials now under way are designed to provide additional information about treatment outcomes regarding total fatalities, persons with a moderate short-term risk for a coronary event, and the longer-term effects of the newer drugs; and (8) these trials are large and open to a broader range of participants, but whether they will provide broader information will depend on their actual enrollments.
Recommendation for Executive Action
Status: Closed - Implemented
Comments: NIH concurred with GAO's recommendation and continues to monitor and evaluate the results of ongoing clinical trials.
Recommendation: The Director, NHLBI, should take steps to closely monitor trials now under way, evaluate their outcomes, and determine whether additional trials should be planned in order to fill in data presently lacking on women, elderly men and women, minority men and women, and persons whose cholesterol levels are relatively low or who otherwise are members of low-risk groups.
Agency Affected: Department of Health and Human Services: Public Health Service: National Institutes of Health: National Heart, Lung, and Blood Institute