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Ibopamine

A Preliminary Review of Its Pharmacodynamic and Pharmacokinetic Properties and Therapeutic Efficacy

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Summary

Synopsis

Ibopamine is an orally active derivative of dopamine which undergoes hydrolysis to the active moiety epinine. In single-dose and short term studies ibopamine demonstrated inotropic and vasodilating properties. It improved cardiac and systemic haemodynamics by increasing cardiac output and reducing afterload, both at rest and during exercise. In non-comparative clinical studies ibopamine produced benefits in functional class and clinical symptoms for up to I year in patients with moderate to severe congestive heart failure. Similarly, short term comparative studies with placebo have indicated ibopamine as a useful adjunct in the treatment of patients maintained on conventional therapy with digoxin, diuretics and vasodilators. Preliminary evidence also suggests that ibopamine is as effective as digoxin in the treatment of patients with moderate congestive heart failure. Should the results of long term comparative studies confirm these encouraging findings, ibopamine will be a useful addition to the drugs available or as an alternative to digoxin for the treatment of congestive heart failure.

Pharmacodynamic Studies

After incubation in plasma, ibopamine possesses α-, β- and dopaminergic agonism similar to epinine in isolated cardiac and vascular preparations. Ibopamine increased the rate of rise of left ventricular pressure in guinea-pigs and dogs, and stroke volume and aortic blood flow in cats. Ibopamine increased renal blood flow, diuresis and electrolyte excretion in animals.

In healthy volunteers and in patients with congestive heart failure, single doses of ibopamine improved indices of myocardial contractility and decreased vascular resistance, without significant effects on heart rate or blood pressure. These haemodynamic improvements occur within 30 minutes, and after oral administration maximal benefits are evident within 1 to 2 hours and thereafter decline. At doses of 200mg and above ibopamine causes biphasic responses, as evidenced by elevations and then reductions in atrial and arterial pressures. Non-invasive studies have also shown improvement in left ventricular function, as observed by decreases in pre-ejection period and electromechanical systole. Double-blind studies with placebo found improvement in the ratio of the pre-ejection period to left ventricular ejection time, but not in the duration of electromechanical systole. Ibopamine increases peripheral blood flow and decreases peripheral resistance; its vasodilating properties appear to be more selective for resistance than capacitance vessels. Short term studies have shown no exacerbation of pre-existing spontaneous premature ventricular beats.

Double-blind short term studies have demonstrated increases in diuresis and natriuresis owing to the activity of ibopamine on peripheral dopaminergic receptors. Equivocal effects on renal function have been observed in single-dose studies. However, short term studies have shown beneficial effects of ibopamine on renal function to improve with time, up to a maximum of approximately 5 days. In comparative single-dose studies, oral ibopamine 200mg produced similar cardiac and renal effects to an infusion of dopamine 4 μg/kg/min. However, whereas dopamine’s effects are maximal within 15 minutes, the peak effects of ibopamine occur approximately 2 hours after ingestion.

Pharmacokinetic Studies

Ibopamine is a prodrug which is rapidly hydrolysed to epinine during and after absorption. Following single oral doses of ibopamine 200mg, maximum plasma concentrations of free epinine (66.5 to 103.5 nmol/L) were achieved within 30 minutes. The peak concentration of free epinine is approximately 2 orders of magnitude lower than that of total epinine, and declines rapidly such that circulating concentrations are barely detectable after 3 hours. The bioavailability of ibopamine appeared proportional to the dose and did not accumulate after long term administration. A reduction in maximum plasma free epinine concentration was observed following administration of ibopamine with food.

Epinine is extensively metabolised, and less than 1% of an oral dose was recovered as unchanged epinine. Epinine is conjugated to 3-O-sulphate and oxidised to homovanillic acid and dihydroxyphenylacetic acid. These metabolites are excreted in the urine and account for about 50 to 85% of the dose recovered in the urine within 24 hours. The elimination half-life of free epinine is about 45 minutes.

Therapeutic Trials

Ibopamine has been used as an additional treatment to the conventional therapy of digitalis, diuretics and vasodilators for patients with moderate to severe congestive heart failure. Non-comparative studies of 1 week to 1 year show that ibopamine maintained the haemodynamic and renal improvement established in single-dose studies without significant alteration to blood pressure and heart rate. In a randomised parallel study, ibopamine 100mg 3 times daily for 10 weeks prevented the deterioration of left ventricular function observed in the parallel group receiving conventional therapy. Improvements in exercise performance were also demonstrated. In a multicentre study of 311 patients, ibopamine was rated as effective in 92% of patients with hypertensive or valvular aetiologies but in only 79% of those with ischaemic aetiology.

In double-blind comparative studies of 10 and 30 days’ duration, ibopamine proved as effective as digoxin for the treatment of patients with moderate congestive heart failure. In a non-blind cohort study of 1,007 patients, ibopamine 100mg 2 or 3 times daily showed comparable efficacy to digoxin 0.25mg daily, for a mean duration of 7.5 months in patients with moderate congestive heart failure. In comparative studies with placebo, ibopamine 100mg 3 times daily for 1 to 2 weeks produced improvements in left ventricular function during rest and exercise, and reductions in clinical symptom scores. Preliminary data suggest that the same dose of ibopamine also improved renal function in patients with chronic congestive heart failure. Lower doses of ibopamine, 50mg 3 times daily for 7 to 26 weeks, increased diuresis, electrolyte excretion and creatinine clearance in those patients with chronic renal insufficiency who had been discontinued from their usual therapy of digitalis and/or diuretics.

Although non-comparative studies have implied that the positive inotropic and vaso-dilating properties of ibopamine are maintained up to 1 year, long term comparative studies are required to clarify its efficacy.

Side Effects

Side effects have been rarely reported, and were usually minor and transient in nature. Gastrointestinal and cardiovascular events accounted for the majority reported. These included dyspepsia, gastric pyrosis, tachycardia and chest pain. Caution should be exercised in treating patients with pre-existing premature ventricular contractions, as exacerbation may occur with high doses.

Dosage and Administration

For the treatment of congestive heart failure, oral ibopamine should be given in a dose of 100mg 3 times daily.

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    Julian M. Henwood & Peter A. Todd

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Various sections of the manuscript reviewed by: R.E.S. Bullingham, Banbury, England; K. Chatterjee, Department of Medicine, University of California, San Francisco, California, USA; J. Col, Université Catholique de Louvain, Brussels, Belgium; J.N. Harvey, The General Infirmary, Leeds, England; H. Ikram, Department of Cardiology, Princess Margaret Hospital, Christchurch, New Zealand; H. Itoh, Tokyo Medical and Dental University, Tokyo, Japan; J.D. Horowitz and A.C. Powell, Departments of Cardiology and Clinical Pharmacology, Austin Hospital, Heidelberg, Victoria, Australia; L. H. Opie, Heart Research Unit and Hypertension Clinic, University of Cape Town, South Africa; S. Stefoni, Nephrology and Dialysis Department, St Orsola University Hospital, Bologna, Italy; D.N. Sharpe and M. Webster, Department of Medicine, University of Auckland, New Zealand.

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Henwood, J.M., Todd, P.A. Ibopamine. Drugs 36, 11–31 (1988). https://doi.org/10.2165/00003495-198836010-00003

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