Efficacy and safety of intermittent intravenous outpatient administration of levosimendan in patients with advanced heart failure: the LION-HEART multicentre randomised trial

Fecha de publicación: 01/07/2018

Autores de IIS La Fe

Luis Almenar Bonet

Autor

Participantes ajenos a IIS La Fe

Comin-Colet, J
Manito, N
Segovia-Cubero, J
Delgado, J
Pinilla, JMG
Crespo-Leiro, MG
Sionis, A
Blasco, T
Pascual-Figal, D
Gonzalez-Vilchez, F
Lambert-Rodriguez, JL
Grau, M
Bruguera, J
LION-HEART Study Investigators

Grupos

Grupo de Investigación Clínica y Traslacional en Cardiología

Investigador Principal

Esther Roselló Lletí

Abstract

Aims The LION-HEART study was a multicentre, double-blind, randomised, parallel-group, placebo-controlled trial evaluating the efficacy and safety of intravenous administration of intermittent doses of levosimendan in outpatients with advanced chronic heart failure. Methods and results Sixty-nine patients from 12 centres were randomly assigned at a 2: 1 ratio to levosimendan or placebo groups, receiving treatment by a 6-hour intravenous infusion (0.2 mu g/kg/min without bolus) every 2weeks for 12weeks. The primary endpoint was the effect on serum concentrations of N-terminal pro-B-type natriuretic peptide (NT-proBNP) throughout the treatment period in comparison with placebo. Secondary endpoints included evaluation of safety, clinical events and health-related quality of life (HRQoL). The area under the curve (AUC, pg.day/mL) of the levels of NT-proBNP over time for patients who received levosimendan was significantly lower than for the placebo group {344 x 10(3) [95% confidence interval (CI) 283 x 10(3)-404 x 10(3)] vs. 535 x 10(3) [443 x 10(3)-626 x 10(3)], P = 0.003}. In comparison with the placebo group, the patients on levosimendan experienced a reduction in the rate of heart failure hospitalisation (hazard ratio 0.25; 95% CI 0.11-0.56; P = 0.001). Patients on levosimendan were less likely to experience a clinically significant decline in HRQoL over time (P = 0.022). Adverse event rates were similar in the two treatment groups. Conclusions In this small pilot study, intermittent administration of levosimendan to ambulatory patients with advanced systolic heart failure reduced plasma concentrations of NT-proBNP, worsening of HRQoL and hospitalisation for heart failure. The efficacy and safety of this intervention should be confirmed in larger trials.

Datos de la publicación

ISSN/ISSNe:: 1388-9842, 1879-0844
Tipo:: Article
Páginas:: 1128-1136
DOI:: 10.1002/ejhf.1145
PubMed:: 29405611
Factor de Impacto:: 5,537 SCImago ℠
Cuartil:: Q1 SCImago ℠

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Métricas

Filiaciones

Comin-Colet, J:: Hosp Mar, Med Res Inst, IMIM, Heart Dis Biomed Res Grp, Barcelona, Spain

Univ Autonoma Barcelona, Barcelona, Spain
Manito, N:: Univ Barcelona, IDIBELL, Hosp Univ Bellvitge, Heart Dis Inst, Lhospitalet De Llobregat, Spain
Segovia-Cubero, J:: Hosp Univ Puerta Hierro, Madrid, Spain
Delgado, J:: Hosp 12 Octubre, Serv Cardiol, Unidad Insuficiencia Cardiaca & Trasplante, Madrid, Spain
Pinilla, JMG:: Hosp Univ Virgen Victoria, Malaga, Spain
Almenar, L:: Hosp Univ & Politecn La Fe, Valencia, Spain
Crespo-Leiro, MG:: Univ A Coruna UDC, CHUAC, La Coruna, Spain

Univ A Coruna UDC, Inst Invest Biomed A Coruna INIBIC, La Coruna, Spain
Sionis, A:: Univ Autonoma Barcelona, Biomed Res Inst IIB St Pau, Hosp Santa Creu & St Pau, Barcelona, Spain
Blasco, T:: Hosp Univ Miguel Servet, Zaragoza, Spain
Pascual-Figal, D:: Hosp Univ Virgen Arrixaca, Murcia, Spain
Gonzalez-Vilchez, F:: Univ Cantabria, Hosp Univ Marques Valdecilla, Santander, Spain
Lambert-Rodriguez, JL:: Hosp Univ Cent Asturias, Unidad Trasplante Cardiaco & Insuficiencia Cardia, Oviedo, Spain
Grau, M:: Hosp Mar, Med Res Inst, IMIM, Cardiovasc Epidemiol & Genet, Barcelona, Spain

Univ Barcelona, Barcelona, Spain
Bruguera, J:: Hosp Mar, Med Res Inst, IMIM, Heart Dis Biomed Res Grp, Barcelona, Spain

Univ Autonoma Barcelona, Barcelona, Spain
LION-HEART Study Investigators:: LION-HEART Study Investigators