Safety and effectiveness of probucol as a cholesterol lowering agent.

Monitored clinical studies conducted in 1133 patients, involving 3928 patient years of experience with probucol, have shown that it is an effective cholesterol lowering agent and is well tolerated during long term administration (some patients treated for as long as nine years). The incidence of morbidity and mortality in patients treated with probucol is in the expected range. Although a possibly protective action is suggestive against certain endpoints, the lack of long term parallel placebo groups does not allow for a statistical contrast of the results. Therefore, it is preferable to limit conclusions to observing that no excess of cardiac deaths, sudden deaths or cardiac morbidity occurred in probucol treated men with or without ischemic heart disease compared with men not receiving probucol.