Intravenous levosimendan vs. dobutamine in acute decompensated heart failure patients on beta-blockers

• Published in: European journal of heart failure 2010-04, Vol.12 (4), p.404-410
• Main Authors: Bergh, Claes-Håkan, Andersson, Bert, Dahlström, Ulf, Forfang, Kolbjorn, Kivikko, Matti, Sarapohja, Toni, Ullman, Bengt, Wikström, Gerhard
• Format: Article
• Language: English
• Subjects: Adrenergic beta-Agonists - administration & dosage; Adrenergic beta-Agonists - therapeutic use; Adrenergic beta-Antagonists - therapeutic use; Aged; Analysis of Variance; Antihypertensive Agents - therapeutic use; Cardiac and Cardiovascular Systems; Cardiotonic Agents - administration & dosage; Cardiotonic Agents - therapeutic use; Clinical Trial; Confidence Intervals; Decompensated heart failure; Dobutamine; Dobutamine - administration & dosage; Dobutamine - therapeutic use; Double-Blind Method; Female; Heart Failure - drug therapy; Heart Failure - pathology; Heart Failure - physiopathology; Hemodynamics; Humans; Hydrazones - administration & dosage; Hydrazones - therapeutic use; Invasive monitoring; Kardiologi; Levosimendan; Male; MEDICIN; MEDICINE; Myocardial Perfusion Imaging; Natriuretic Peptide, Brain - blood; Natriuretic Peptide, Brain - drug effects; Odds Ratio; Perfusion; Pulmonary Wedge Pressure; Pyridazines - administration & dosage; Pyridazines - therapeutic use; Vasodilator Agents - administration & dosage; Vasodilator Agents - therapeutic use
• ISSN: 1388-9842; 1879-0844; 1879-0844
• DOI: 10.1093/eurjhf/hfq032

Aims The aim of this study is to compare the effects of a 24 h intravenous infusion of levosimendan and a 48 h infusion of dobutamine on invasive haemodynamics in patients with acutely decompensated chronic NYHA class III–IV heart failure. All patients were receiving optimal oral therapy including a β‐blocker. Methods and results This was a multinational, randomized, double‐blind, phase IV study in 60 patients; follow‐up was 1 month. There was a significant increase in cardiac index and a significant decrease in pulmonary capillary wedge pressure (PCWP) at 24 and 48 h for both dobutamine and levosimendan. The improvement in cardiac index with levosimendan was not significantly different from dobutamine at 24 h (P = 0.07), but became significant at 48 h (0.44 ± 0.56 vs. 0.66 ± 0.63 L/min/m2; P = 0.04). At 24 h, the reduction in the mean change in PCWP from baseline was similar for levosimendan and dobutamine, however, at 48 h the difference was more marked for levosimendan (−3.6 ± 7.6 vs. −8.3 ± 6.7 mmHg; P = 0.02). No difference was observed between the groups for change in NYHA class, β‐blocker use, hospitalizations, treatment discontinuations or rescue medication use. Reduction in B‐type natriuretic peptide (BNP) was significantly greater with levosimendan at 48 h (P = 0.03). According to physician's assessment, the improvement in fatigue (P = 0.01) and dyspnoea (P = 0.04) was in favour of dobutamine treatment, and hypotension was significantly more frequent with levosimendan (P = 0.007). No increase in atrial fibrillation or ventricular tachycardia was seen in either group. Conclusion A 24 h levosimendan infusion achieved haemodynamic and neurohormonal improvement that was at least comparable at 24 h and superior at 48 h to a 48 h dobutamine infusion.