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

Comin-Colet, J. ; Manito, N. ; Segovia-Cubero, J. ; Delgado, J. ; Pinilla, J.M.G. ; Almenar, L. ; Crespo-Leiro, M.G. ; Sionis, A. ; Blasco, T. (Universidad de Zaragoza) ; Pascual-Figal, D. ; Gonzalez-Vilchez, F. ; Lambert-Rodriguez, J.L. ; Grau, M. ; Bruguera, J.

Resumen: 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.

Idioma: Inglés

DOI: 10.1002/ejhf.1145

Año: 2018

Publicado en: European Journal of Heart Failure 20, 7 (2018), 1128-1136
ISSN: 1388-9842

Factor impacto JCR: 13.965 (2018)

Categ. JCR: CARDIAC & CARDIOVASCULAR SYSTEMS rank: 6 / 136 = 0.044 (2018) - Q1 - T1

Factor impacto SCIMAGO: 5.537 - Cardiology and Cardiovascular Medicine (Q1)

Tipo y forma: Article (Published version)

Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)