By Scott M. Grundy
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Additional resources for Cholesterol-Lowering Therapy: Evaluation of Clinical Trial Evidence
In the current volume (59). Three trials (60-62) employed intervention on life habits alone; two studies (60,62) used bile acid sequestrants; two others (64,65) employed fibrates alone; and nine trials (66-74) made use of statins alone. Five other trials (75-80) employed combined drug therapy, whereas one study (50) employed the ileal bypass to obtain cholesterol lowering. The details of these trials are presented in other chapters in this volume. A. Angiographic versus Clinical Endpoints In most of the angiographic trials, clinical endpoints were recorded in addition to angiographic trials.
The strength of the POSCH trial grew out of a marked and persistent lowering of LDL cholesterol levels; this study demonstrated clearly that cholesterol lowering reduces major CHD events. B. Unresolved Issues Earlier secondary prevention trials provided mixed results although several of them gave positive results. Generally, the drug trials were more positive than the dietary trials. The two MRC dietary studies (42,43) were taken to be negative; small trends toward benefit of cholesterol lowering did not reach statistical significance.
0 g/day ; and placebo. There were approximately five placebo patients for every two patients on any drug regimen. The primary endpoint was total mortality, and secondary endpoints included various major coronary events. 0 mg/day of D-thyroxine-were discontinued because of trends indicative of adverse effects. The three other regimens-clofibrate, nicotinic acid, and placebo-were continued until the end of the study. Most patients in the latter three groups had at least 5 years of follow-up. The patients treated with clofibrate showed no evidence of benefit, either in total mortality or in cause-specific mortality.