6-MONTH TREATMENT OF CONGESTIVE-HEART-FAILURE WITH IBOPAMINE - A DOUBLE-BLIND RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER TRIAL

Efficacy and safety of adding ibopamine 200 mg three times daily to digoxin and diuretics in 111 patients with moderate congestive heart failure were evaluated in a double-blind randomized, placebo-controlled trial. The design incorporated three phases: (1) a 2-month double-blind period; (2) a 4-month blinded extension, and (3) a 6-month open-treatment phase with all patients on ibopamine. The results showed that when ibopamine was added to the standard therapy, it improved clinical symptoms at weeks 8 and 24 and New York Heart Association class and exercise tolerance at week 24 as compared with placebo. Chemical improvement was maintained during the final open 6 months of ibopamine. There was no increase in mortality from cardiac arrhythmias or other serious cardiorespiratory events in patients on ibopamine as compared with patients on placebo. Ibopamine was associated with a greater number of gastrointestinal complaints than placebo, but these infrequently caused withdrawal. This novel vasodilator may offer an additional therapeutic option in the management of congestive heart failure.