Long-term therapy of chronic congestive heart failure with ibopamine: a multicenter trial.
The present multicenter open investigation was designed to provide information on the adverse reaction rate, drug interaction, and survival in a group of 544 cardiac patients treated for 1 year with ibopamine either alone or in association with digitalis, diuretics, and other drugs. Some efficacy parameters were also considered. Heart failure was due to idiopathic dilated cardiomyopathy (21%), ischemic heart disease (32%), hypertensive heart disease (31%), and others (16%). Ibopamine was given alone to 39 patients; the others were given the drug in association with digitalis, diuretics, and vasodilators. One hundred forty patients did not complete the trial (25.7%). The most common causes of discontinuation were death (12.5%), noncompliance with the protocol (5%), and adverse events (3.9%). The clinical conditions and NYHA functional class improved in most patients. The cardiothoracic ratio decreased on average. The 1-year mortality rates associated with NYHA class II, III, and IV were 4.4, 13.8, and 37.2%, respectively. Survival tended to be shorter in a small group of 22 patients with hyponatremia, thus confirming some previous reports. Adverse experiences were mainly related to cardiovascular and gastrointestinal systems; the symptoms were considered severe only in 1 of 544 patients enrolled. Ibopamine seems not to induce dangerous arrhythmias. Blood pressure and heart rate did not change over time during ibopamine treatment. Laboratory tests were not significantly affected; fluctuations observed in some tests were related to concomitant variations in the severity of the primary disease. No tolerance to ibopamine seems to be observed during this long-term therapeutic trial.
Rolandi
E
E
ISMI, Universita' degli Studi di Genova, Italy.
Sabino
F
F
Cantoni
V
V
Ghirardi
P
P
Marchetti
G V
GV
Cicchetti
V
V
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002316:Cardiotonic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D002908:Chronic Disease; D003846:Deoxyepinephrine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004298:Dopamine / Q000031:analogs & derivatives*; D004341:Drug Evaluation; D004347:Drug Interactions; D004359:Drug Therapy, Combination; D004452:Echocardiography; D005260:Female; D006333:Heart Failure / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D015996:Survival Rate; D013997:Time Factors; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000009:adverse effects*
D002316:Cardiotonic Agents; D014665:Vasodilator Agents; C023487:ibopamine; D003846:Deoxyepinephrine; D004298:Dopamine