A SURVEY OF 311 PATIENTS RECEIVING IBOPAMINE MAINLY DURING HOSPITAL TREATMENT FOR SEVERE CONGESTIVE-HEART-FAILURE

  • 1 January 1986
    • journal article
    • research article
    • Vol. 36-1  (2A) , 398-405
Abstract
From a monitored release of ibopamine, the 3,4-diisobutyryl ester of N-methyldopamine, during the early Italian marketing of the drug a collection of 311 indivudal cases was formed. The cases were reported by 168 cardiologist-practitioners, self-selected for having a therapeutic interest in the inotropic properties of ibopamine and in trying it out in patients with mostly severe, refractory congestive heart failure (CHF). Most patients were monitored during a hospital admission for worsened CHF. After clinical reassessment and other drugs'' adjustment, ibopamine was added and the patient followed-up for 20 days in hospital with regular recording of scored signs and symptoms, arterial pressure, heart rate, body weight, and any clinical event - adverse or beneficial. Concomitant drugs were also recorded. Global assessment of efficacy was mostly positive, with "ineffective" rates of only 15.9% (doctors) and 14.2% (patients). In the absence of a control group, it is impossible to determine to what extent the foregoing was really due to ibopamine or to the rest of the therapeutic policy. However, the fact that most of the severe cases had been refractory to prior treatment, and that they indiviudally carried a grave prognosis on admission, do seem to point to real ibopamine-related benefit. The high rate of symptomatic beneft perceived by the patients would also seem likely to be drug-related. Heart rate after the ibopamine-including regimen was significantly lower than before. Systolic and diastolic arterial pressures also tended to decrease, especially in CHF of hypertensive etiology. If related to ibopamine, these data would confirm the drug as capable of reducing total peripheral vascular resistance without increasing heart rate and cardiac work. There were 14 deaths, all of which were attributed to unrelented progression of the underlying CHF; none of them was unexpected. They occurred mainly in NYHA (New York Heart Association) Class IV patients with CHF of postinfarction or idiopathic etiology. There were 3 strokes, all in patients who had other risk factors in addition to Class IV CHF. The foregoing serious events do not seem to be in excess of what one would expect in about 250 hospital admissions for Class IV + III CHF. There were actually also several unexpected survivals that were attributed to ibopamine. The real incidence of these and other events will have to be measured in a prospective, parallel cohorts study. Adverse events (other than natural progression/complication of underlying CHF) were 91 in 70 patients (22.5% of 311), with some degree of causal relationship to ibopamine confirmed in 14 cases. The gastrointestinal and cardiovascular manifestations were the most frequent, and they have been discussed in some detail with a view at their possible mechanism and prevention.