Safety profile of bepridil determined from clinical trials in chronic stable angina in the United States.

Bepridil is a unique calcium antagonist with a broad pharmacologic profile and demonstrated efficacy as an antianginal agent. Data from US clinical trials of bepridil in 840 patients (820 with chronic stable angina; 20 with vasospastic angina) indicated that the drug is well tolerated. The most frequent adverse reactions were of gastrointestinal or neurologic origin. Although bepridil has negative inotropic potential, a contributory role of the drug could not be precisely determined in 24 cases of congestive heart failure. Bepridil (median dose, 300 mg/day) lengthened the corrected QT (QTc) interval in most patients. The mean increase was 7.7%. Torsades de pointes occurred in 7 patients, an incidence of approximately 1%. Prolonged QT/QTc interval, low serum potassium level, or use of a potassium-wasting diuretic was present in each case. A life-table analysis involving 712 patients showed a 1-year overall survival rate of 97.1%. A 1-year survival rate of 97% was also determined by comparing 652 bepridil-treated patients with 1,361 matched control subjects from a data base of greater than 10,000 patients referred to the Duke University Medical Center for cardiac catheterization. Based on US clinical trials, the overall safety results indicate an acceptable safety profile of bepridil when this calcium antagonist is used in the treatment of chronic stable angina.