SAFETY AND EFFICACY OF MONOTHERAPY WITH FANTOFARONE, A NOVEL CALCIUM-CHANNEL ANTAGONIST, IN PATIENTS WITH CHRONIC STABLE ANGINA-PECTORIS

Fantofarone is a calcium channel antagonist of a class (sulfone indoli zine) that is structurally different from the existing classes. The pr imary cardiac action of fantofarone is on the sinus node, although it is also a potent peripheral and coronary vasodilator. This is a multic enter, double-blind, randomized, placebo-controlled, dose-ranging stud y evaluating the efficacy and safety of fantofarone. Three hundred and thirty patients were included as intent-to-treat, and 299 patients co mpleted the entire protocol. Doses of fantofarone studied were 50, 200 , 250, and 200 mg twice daily. The 100- and 150-mg groups demonstrated antianginal activity, prolonging exercise time walking on a treadmill by 38 and 45 seconds to the endpoint of moderate angina, compared wit h the placebo group. Sinus bradycardia occurred in 23 patients and was somewhat dose-related. Systolic blood pressure at rest and while exer cising was not altered by therapy. No deaths occurred in the treated g roup. Of the 20 patients in the treatment group who did not complete t he protocol (compared with 23 in the placebo group) 6 were dropped bec ause of symptomatic bradycardia, 5 because of increased angina, and 9 for miscellaneous reasons. Ln doses of 100 mg to 250 mg twice daily, m onotherapy fantofarone was effective and safe in the treatment of pati ents with chronic, stable angina pectoris.