Summary

Efficacy of early administration of levosimendan in emergency department in patients with acute heart failure: a randomized pilot clinical trial

Llorens P, Miró O, Román F, Zapater P, Carbajosa Dalmau J, Llanos L

Affiliation of the authors

Servicio de Urgencias-UCE, Hospital General Universitario de Alicante, Spain. Àrea de Urgencias, Hospital Clínic. Grupo de investigación “Urgencias: procesos y patologías” IDIBAPS, Barcelona, Spain. Servicio de Farmacología Clínica, Hospital General Universitario de Alicante, Spain.

DOI

Quote

Llorens P, Miró O, Román F, Zapater P, Carbajosa Dalmau J, Llanos L. Efficacy of early administration of levosimendan in emergency department in patients with acute heart failure: a randomized pilot clinical trial. Emergencias. 2013;24:268-76

Summary

Objective: To compare the efficacy and safety of early levosimendan administration in

addition to standard treatment in patients with severe symptoms of decompensated

heart failure attended in the emergency department (ED).

Methods: A single-center, prospective, third-party blinded, randomized, placebo

controlled, pilot study was performed in 45 patients with advanced heart failure

attended in the ED. Patients were randomized 1:1 to receive intravenous levosimendan

or placebo in addition to standard care. The primary endpoint was improvement in

baseline dyspnea over 24 hours. Improvement of orthopnea, jugular ingurgitation and

peripheral edema, cumulated diuresis and changes in systolic and diastolic blood

pressure and in heart and respiratory rates were also registered. Adverse events during

treatment were recorded. Patients were followed for 7 days and at 1 and 6 months after

hospital discharge for all causes of hospital readmission, mortality or both.

Results: Dyspnea improved faster and in more patients with the use of levosimendan

(P<0.05). Similar findings were found for orthopnea (P<0.05), with no differences for the remaining variables. Adverse effects were observed in 20% and 25% of patients in the levosimendan and placebo groups, respectively (P=NS), with no patients withdrawn from the protocol. No differences were seen with respect to readmission, mortality or both outcomes in combination. Conclusion: Early treatment with levosimendan produces no significant differences in readmission or mortality rates, although it is associated with a significant clinical benefit in terms of improvement in dyspnea and orthopnea compared with placebo.

 

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