The National Cholesterol Education Program

National Heart, Lung, and Blood Institute (NHLBI) education campaigns address several of the modifiable risk factors, including high blood cholesterol levels, smoking, obesity, and hypertension. Additional, more recent data have brought greater agreement that cholesterol treatment helps prevent deaths among persons who have a history of CHD. Principal Findings

		The Benefits and Risks of Lowering Cholesterol

			Nonfatal and Fatal CHD Outcomes

The meta-analyses we reviewed consistently reported a statistically significant reduction in the rates of nonfatal heart attacks for the trial participants who were treated for high cholesterol compared to those who did not receive treatment. Types of Treatment

Several of the trials tested various dietary treatments, but most of these used diets that differ from the ones that are now recommended and used to treat persons with high cholesterol. Many are being addressed by new trials that should help answer some of the questions about non-CHD deaths and total fatalities, CHD outcomes for persons whose short-term risk of heart disease is moderate, CHD outcomes for population groups other than middle-aged white men, and the long-term effects of the statin drugs. We judged 30 of these as inappropriate to our objectives for the following reasons: (1) individual trials were not quantitatively aggregated, (2) aggregated trials were not primarily cholesterol-lowering interventions, (3) analytic detail was insufficient (for example, we excluded a meta-analysis when we were unable to determine the number or identity of the studies it included), (4) the number of individual trials was insufficient (for example, we excluded meta-analyses that included no more than two randomized trials of a year or more in duration), (5) the study was not published or not published in English, and (6) the clinical CHD outcomes we focused on had not been examined. Greater reductions in serum cholesterol were associated with a reduction in deaths from all causes. The odds ratios show that compared to nontreatment groups, non-CHD fatality rates increased. A recently completed NHLBI-funded study of coronary heart disease among high-risk men who had never had a heart attack had found a significant reduction in combined CHD in the group whose cholesterol was lowered by means of drugs. Clinical Trials Unit Mt. A recorded menu will provide information on how to obtain these lists.
Why GAO Did This Study

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.

What GAO Found

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.