IBOPAMINE - LONG-TERM SAFETY STUDY IN PATIENTS WITH CONGESTIVE HEART-FAILURE

Abstract

Ibopamine is a new orally active dopamine analogue with positive inotropic and vasodilating activity. The tolerability of the drug administered at the dose of 100 mg thrice daily for 12 months was studied in 302 patients with congestive heart failure, New York Heart Association (NYHA) class II and III. Of the 302 patients, 198 completed the study (65%); 59 patients (19%) were withdrawn for clinical events; 27 of them died (9%); 35 patients (12%) did not complete the study for non-compliance and 10 (3%) for protocol violations. Clinical events were generally related to the cardiovascular system and 85% of deaths were from cardiovascular causes. None of the deaths was considered related to treatment by the investigators. Clinically significant laboratory abnormalities were observed during the study in four patients only. This trial suggests that ibopamine is well tolerated in patients with congestive heart failure, NYHA class II and III, at the dose of 100 mg thrice daily for up to one year.