Multicenter study on the clinical efficacy of chronic ibopamine administration.

The purpose of this multicenter study was to evaluate the therapeutic efficacy of ibopamine (SB-7505), the 3,4-diisobutyrylester of N-methyldopamine, chronically administered to patients with severe congestive heart failure (CHF) in whom traditional therapy had been ineffective. 55 patients chronically treated with cardiac glycosides and diuretics were assigned to an investigation covering three stages each lasting 7 days. Stage A: continuation of traditional therapy (glycosides and diuretics). Stage B: addition of ibopamine to the glycoside/diuretic therapy. Stage C: withdrawal of ibopamine. Heart rate, blood pressure, body weight, diuresis and 8 target symptoms of CHF (clinical scores) and hematochemical parameters were recorded throughout the three stages. The addition of ibopamine to traditional therapy led to a significant improvement. By contrast, after ibopamine had been withdrawn patients worsened. No hematochemical parameters were modified during the trial. None of the patients experienced any significant side-effects.