Safety of bepridil: from review of the European data

In France, bepridil has been available since 1981 for treatment of angina. Reports of arrhythmogenic effects (torsades de pointes) related to bepridil led to the assembly of a task force of physicians from France and the Netherlands. The task force found that the risk of torsades de pointes was indeed increased in elderly patients, especially women greater than 70 years old, as well as in those taking diuretics, which can precipitate hypokalemia. Postmarketing surveillance data developed from 1981 to 1989 have revealed 108 validated episodes of torsades de pointes in patients treated with bepridil. Improved patient selection has dramatically decreased the incidence of this complication. Several comparative clinical trials assessing the safety of bepridil have concluded that the drug may prolong the QT interval in certain patients; however, no occurrence of torsades de pointes was documented in these safety studies. The 9-year French experience suggests that bepridil is a safe and effective agent for treatment of angina pectoris in properly selected patients.