[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)].
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| Abstract |
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.
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| Authors | R E Tedeschi, B L Martz, H A Taylor, B J Cerimelle |
| Journal | La Nouvelle presse medicale (Nouv Presse Med) Vol. 9 Issue 40 Pg. 3021-7 (Oct 30 1980) ISSN: 0301-1518 [Print] France |
| Vernacular Title | Etude clinique à long terme (9 ans) de la tolérance et de l'efficacité du probucol. Analyse de la morbidité et de la mortalité. |
| PMID | 7003530 (Publication Type: Clinical Trial, Comparative Study, English Abstract, Journal Article) |
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