[Methodology of phase III clinical trials of hypocholesteremic agents. Do any reliable substitution criteria exist?]

Abstract

Pathological events such as myocardial infarction or cardiac death due to hypercholesterolaemia are easily quantified and reliable parameters for assessing the value of lowering the serum cholesterol. However, these events are relatively rare during Phase III clinical trials, the duration of which does not exceed 1 year. To solve this problem, intermediary or substitute criteria have to be used which are predictive of cardiovascular complications related to this pathology. Substitute criteria such as total cholesterol LDL-cholesterol and HDL-cholesterol have been validated by epidemiological and/or clinical studies which have established their predictive value. These primary and secondary prevention trials and regression studies have been analysed. The possibility of more sensitive predictive values of certain lipid fractions and particles is discussed.