Cholesterol Treatment

Clinical trials and other scientific studies have consistently shown that cholesterol-lowering treatment benefits middle-aged white men with high cholesterol levels and a history of heart disease. Medical research also shows that men with moderate-to-high cholesterol levels and no history of heart disease have lower rates of nonfatal heart attacks but no statistically significant reductions in death rates as a result of cholesterol-lowering treatment. Clinical trials generally have not evaluated the value of cholesterol-lowering treatment for several important groups, including women, the elderly, and minorities. Thus, they provide little or no evidence of benefits or possible risks for these groups. Two recent trials using a new drug class--the statins--show greater reductions in heart problems with their greater reductions in cholesterol and no increase in fatalities from coronary heart disease. One trial studied men and women with coronary heart disease and found a significant reduction in total fatalities; the other, which studied only men who did not have coronary heart disease, showed encouraging but not statistically significant reductions in fatalities from coronary heart disease.

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.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

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