[A long-term (9 years) clinical study of the safety and efficacy of probucol, and an analysis of morbidity and mortality rates (author's transl)].
The lowering effect of probucol on plasma cholesterol was confirmed in 1 133 patients. The study covered 9 years and approximately 4 000 patient-years. The daily dosage of probucol was 1 g divided into two 500 mg doses. On average, plasma cholesterol values decreased from 300 mg/dl to about 240 mg/dl. There was no tendency to escape. The study also included measurements of plasma probucol in patients under long-term treatment. The drug was generally well tolerated; the only complaints were episodes of loose stools or diarrhea which did not usually oblige to interrupt treatment. The morbidity and mortality rates in these 1 133 patients were compared with those of two major epidemiological surveys: the Coronary Drug Project and the WHO studies. Statistical analysis was impossible, as our long-term trial did not include patients under placebo. However, no unexpected overall excess of mortality was observed with long-term probucol treatment; there was no increase in morbidity, nor in sudden deaths or deaths from coronary disease. These findings apply equally to patients with or without a history of coronary disease prior to their entry into the trial.
D000328:Adult; D002784:Cholesterol / Q000097:blood; D002986:Clinical Trials as Topic; D003327:Coronary Disease / Q000401:mortality; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006937:Hypercholesterolemia / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D010636:Phenols / Q000627:therapeutic use*; D011341:Probucol / Q000009:adverse effects / Q000627:therapeutic use*
D010636:Phenols; D002784:Cholesterol; D011341:Probucol
Etude clinique à long terme (9 ans) de la tolérance et de l'efficacité du probucol. Analyse de la morbidité et de la mortalité.