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

Josep Comín-Colet, Nicolás Manito, Javier Segovia-Cubero, Juan Delgado, José Manuel García Pinilla, Luis Almenar, María G. Crespo-Leiro, Alessandro Sionis, Teresa Blasco, Domingo Pascual-Figal, Francisco Gonzalez-Vilchez, José Luis Lambert-Rodríguez, María Grau, Jordi Bruguera

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    Abstract

    © 2018 The Authors. European Journal of Heart Failure © 2018 European Society of Cardiology 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 μg/kg/min without bolus) every 2 weeks for 12 weeks. 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 × 103 [95% Confidence Interval (CI) 283 × 103−404 × 103] vs. 535 × 103 [443 × 103−626 × 103], 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.
    Original languageEnglish
    Pages (from-to)1128-1136
    JournalEuropean Journal of Heart Failure
    Volume20
    Issue number7
    DOIs
    Publication statusPublished - 1 Jul 2018

    Keywords

    • Advanced heart failure
    • Levosimendan
    • Natriuretic peptides
    • Outpatient setting
    • Pulsed infusions
    • Safety

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