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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

Servicio de Urgencias-UCE, Hospital General Universitario de Alicante, Spain. √Ärea de Urgencias, Hospital Cl√≠nic. Grupo de investigaci√≥n ¬ďUrgencias: procesos y patolog√≠as¬Ē IDIBAPS, Barcelona, Spain. Servicio de Farmacolog√≠a Cl√≠nica, Hospital General Universitario de Alicante, Spain.

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levosimendan and placebo groups, respectively (P=NS), with no patients withdrawn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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