Authors' objectives:

The aim of this report was to assess the evidence on the clinical usefulness of levosimendan for the treatment of decompensated heart failure.

Authors' results and conclusions: Seven controlled randomized studies were found. In all of them, significant improvement in hemodynamic parameters was seen (decrease pulmonary capillary pressure and increase in cardiac output) when levosimendan was administered to patients with decompensated heart failure with low output and low left ventricular ejection fraction, both when compared against dobutamine and placebo. Three of these studies assessed mortality as secondary endpoint, at 30 and 180 days, observing a decrease in mortality of about 45% for levosimendan. On the other hand, one study observed a reduction in hospital stay with levosimendan. Few adverse effects were reported; the most frequent being arterial hypotension, nausea and a greater tendency towards sinus tachycardia, when compared to placebo.

Authors' recommendations: The present treatment for decompensated heart failure (HF) is under reevaluation because the inotropic drugs used today have not demonstrated to decrease mortality. In this context, levosimendan has demonstrated a hemodynamic improvement in comparison with dobutamine and placebo, being relatively well tolerated and, different from dobutamine, does not seem to be contraindicated for ischemic pathology. One important limitation lies in that all the studies assessed mainly intermediate hemodynamic results. In the three studies where mortality was evaluated as a secondary endpoint, a favorable tendency was observed for levosimendan. If new studies confirm that the improvement in hemodynamic patterns is accompanied by a good safety profile and a decrease in mortality, levosimendan will become a first line drug for the treatment of hospitalized patients with decompensated HF, impaired left ventricular systolic function, of any etiology, who present with hemodynamic impairment and who are refractory to conventional treatment with diuretics, vasodilators, and, eventually, other inotropic agents.

Authors' methods: Overview

Project Status: Completed

URL for project: http://www.iecs.org.ar/

Year Published: 2005

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Argentina

Organisation Name: Institute for Clinical Effectiveness and Health Policy

Contact Address: Dr. Emilio Ravignani 2024, Buenos Aires - Argentina, C1414 CABA

Contact Name: info@iecs.org.ar

Contact Email: info@iecs.org.ar

Copyright: Institute for Clinical Effectiveness and Health Policy (IECS)