Lipid intervention trials in primary prevention: a critical review.

On the basis of six randomized primary intervention trials, major changes in the diagnosis and treatment of relatively mild hypercholesterolemia have been strongly advocated. This paper examines the data from these six trials which show a significant reduction in morbidity and mortality from coronary heart disease but no decrease in overall mortality because of concomitant increases of cancer and violent deaths in the treated half. These adverse effects cannot be decisively proven to be related to the reduction in cholesterol levels but they also cannot be disregarded as biological or statistical quirks. In view of the limited positive evidence and the serious reservations about negative effects, caution is advised in the advocacy of more widespread therapy of all people with even minimal degrees of hypercholesterolemia. In particular, the limited effectiveness and the large expense of such broad therapy threaten to aggravate further the critical health care cost crisis.