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Título : Efficacy and safety of intermittent intravenous outpatient administration of levosimendan in patients with advanced heart failure: the LION-HEART multicentre randomised trial
Autor : Comin-Colet, Josep
Manito, Nicolas
Segovia-Cubero, Javier
Delgado, Juan
Garcia Pinilla, Jose Manuel
Almenar, Luis
Crespo-Leiro, Maria G.
Sionis, Alessandro
Blasco, Teresa
Pascual-Figal, Domingo
Gonzalez-Vilchez, Francisco
Luis Lambert-Rodriguez, Jose
Grau, Maria
Bruguera, Jordi
LION-HEART Study Investigators
Filiación: [Comin-Colet, Josep] Hosp Mar, Med Res Inst, IMIM, Heart Dis Biomed Res Grp, Barcelona, Spain
[Bruguera, Jordi] Hosp Mar, Med Res Inst, IMIM, Heart Dis Biomed Res Grp, Barcelona, Spain
[Comin-Colet, Josep] Univ Autonoma Barcelona, Barcelona, Spain
[Bruguera, Jordi] Univ Autonoma Barcelona, Barcelona, Spain
[Manito, Nicolas] Univ Barcelona, IDIBELL, Hosp Univ Bellvitge, Heart Dis Inst, Lhospitalet De Llobregat, Spain
[Segovia-Cubero, Javier] Hosp Univ Puerta Hierro, Madrid, Spain
[Delgado, Juan] Hosp 12 Octubre, Serv Cardiol, Unidad Insuficiencia Cardiaca & Trasplante, Madrid, Spain
[Garcia Pinilla, Jose Manuel] Hosp Univ Virgen Victoria, Malaga, Spain
[Almenar, Luis] Hosp Univ & Politecn La Fe, Valencia, Spain
[Crespo-Leiro, Maria G.] Univ A Coruna UDC, CHUAC, La Coruna, Spain
[Crespo-Leiro, Maria G.] Univ A Coruna UDC, Inst Invest Biomed A Coruna INIBIC, La Coruna, Spain
[Sionis, Alessandro] Univ Autonoma Barcelona, Biomed Res Inst IIB St Pau, Hosp Santa Creu & St Pau, Barcelona, Spain
[Blasco, Teresa] Hosp Univ Miguel Servet, Zaragoza, Spain
[Pascual-Figal, Domingo] Hosp Univ Virgen Arrixaca, Murcia, Spain
[Gonzalez-Vilchez, Francisco] Univ Cantabria, Hosp Univ Marques Valdecilla, Santander, Spain
[Luis Lambert-Rodriguez, Jose] Hosp Univ Cent Asturias, Unidad Trasplante Cardiaco & Insuficiencia Cardia, Oviedo, Spain
[Grau, Maria] Hosp Mar, Med Res Inst, IMIM, Cardiovasc Epidemiol & Genet, Barcelona, Spain
[Grau, Maria] Univ Barcelona, Barcelona, Spain
Palabras clave : Levosimendan;Pulsed infusions;Outpatient setting;Advanced heart failure;Safety;Natriuretic peptides;Clinical-evidence;Management
Fecha de publicación : 1-jul-2018
Editorial : Wiley
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.
URI: http://hdl.handle.net/10668/14598
DOI: 10.1002/ejhf.1145
ISSN : 1388-9842
Aparece en las colecciones: Producción 2020

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