Randomised study of effect of ibopamine on survival in patients with advanced severe heart failure Hampton, J.R.; Veldhuisen, D.J.; Kleber, F.X.; Cowley, A.J.; Ardia, A.; Block, P.; Cortina, A.; Cserhalmi, L.; Follath, F.; Jensen, G.; Kayanakis, J.; Lie, K.I.; Mancia, G.; Skene, A.M. Published in: Lancet DOI:10.1016/S0140-6736(96)10488-8 Link to publicationCitation for published version (APA): Hampton, J. R., Veldhuisen, D. J., Kleber, F. X., Cowley, A. J., Ardia, A., Block, P., ... Skene, A. M. (1997). Randomised study of effect of ibopamine on survival in patients with advanced severe heart failure. Lancet, 349, 971-977. https://doi.org/10.1016/S0140-6736(96)10488-8 General rightsIt is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), other than for strictly personal, individual use, unless the work is under an open content license (like Creative Commons). Disclaimer/Complaints regulationsIf you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the material inaccessible and/or remove it from the website. Please Ask the Library: http://uba.uva.nl/en/contact, or a letter to: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. You will be contacted as soon as possible. Download date: 22 Mar 2019Randomised study of effect of ibopamine on survival in patients with advanced severe heart failure J R Hampton, D J van Veldhuisen, F X Kleber, A J Cowley, A Ardia, P Block, A Cortina, L Cserhalmi, F Follath, G Jensen, J Kayanakis, K I Lie, G Mancia, A M Skene, for the Second Prospective Randomised Study of Ibopamine on Mortality and Efficacy (PRIME II) Investigators THE LANCET SummaryBackground Drugs that improve symptoms in patients with heart failure must also be assessed for their effects on survival. Ibopamine stimulates DA-1 and DA-2 receptors and causes peripheral and renal vasodilatation; the drug improves symptoms of heart failure. W e assessed the effect of ibopamine on survival in patients with advanced heart failure in a mult ic ent re, randomised plac ebocontrolled study.

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France1 Two hundred and eleven patients with mild or moderate hypertension, mean age 53.5 + 9.5 years (range 24-70) were randomised double-blind to treatment with either captopril 50 mg (C50), hydrochlorothiazide 25 mg (HCTZ25), the fixed combination of captopril 50 mg and hydrochlorothiazide 25 mg (C50/HCTZ25) or placebo. 2 Blood pressure, heart rate, body weight and side effects were assessed at the end of the run-in period on placebo and after 4, 6, 8 weeks treatment at the same time, 20-24 h after the last dosing. Routine biochemical examinations were carried out on all patients after the placebo period as well as after 4 and 8 weeks. 3 Blood pressure significantly decreased in all groups, but the mean percentage change from baseline was highly statistically significant at 8 weeks, for C50 and C50/HCTZ25 groups. 4 The incidence of clinical side effects was low and not statistically different for the four groups with few specific adverse effects (one transient alteration of taste in captopril group). No patient was withdrawn from the study due to side effects. 5 A better anti-hypertensive efficacy was obtained with the fixed combination captopril 50 mg/hydrochlorothiazide 25 mg once daily compared to placebo or each component alone, and without any difference in side effects.

Efficacy and safety of adding ibopamine 200 mg three times daily to digoxin and diuretics in 111 patients with moderate congestive heart failure were evaluated in a double-blind randomized, placebo-controlled trial. The design incorporated three phases: (1) a 2-month double-blind period; (2) a 4-month blinded extension, and (3) a 6-month open-treatment phase with all patients on ibopamine. The results showed that when ibopamine was added to the standard therapy, it improved clinical symptoms at weeks 8 and 24 and New York Heart Association class and exercise tolerance at week 24 as compared with placebo. Chemical improvement was maintained during the final open 6 months of ibopamine. There was no increase in mortality from cardiac arrhythmias or other serious cardiorespiratory events in patients on ibopamine as compared with patients on placebo. Ibopamine was associated with a greater number of gastrointestinal complaints than placebo, but these infrequently caused withdrawal. This novel vasodilator may offer an additional therapeutic option in the management of congestive heart failure.

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