Efficacy and safety of intermittent repeated levosimendan infusions in advanced heart failure patients: the LAICA study

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  • dc.contributor.author García-González, Martín J.
  • dc.contributor.author Aldea-Perona, Ana
  • dc.contributor.author Lara-Padrón, Antonio
  • dc.contributor.author Morales Rull, José Luis
  • dc.contributor.author Martínez-Sellés, Manuel
  • dc.contributor.author Mora Martin, Manuel de
  • dc.contributor.author López Díaz, Javier
  • dc.contributor.author López Fernández, Silvia
  • dc.contributor.author Ortiz Oficialdegui, Pilar
  • dc.contributor.author Jiménez Sosa, Alejandro
  • dc.date.accessioned 2022-06-02T06:36:32Z
  • dc.date.available 2022-06-02T06:36:32Z
  • dc.date.issued 2021
  • dc.description.abstract Aims: The aim of the LAICA study was to evaluate the long-term effectiveness and safety of intermittent levosimendan infusion in patients with advanced heart failure (AdHF). Methods and results: This was a multicentre, randomized, double-blind, placebo-controlled clinical trial of intermittent levosimendan 0.1 μg/kg/min as a continuous 24-h intravenous infusion administered once monthly for 1 year in patients with AdHF. The primary endpoint [incidence of rehospitalization (admission to the emergency department or hospital ward for >12 h) for acute decompensated HF or clinical deterioration of the underlying HF] occurred in 23/70 (33%) of the levosimendan group (Group I) and 12/27 (44%) of the placebo group (Group II) (P = 0.286). The incidence of hospital readmissions for acute decompensated HF (Group I vs. Group II) at 1, 3, 6, and 12 months was 4.2% vs. 18.2% (P = 0.036); 12.8% vs. 33.3% (P = 0.02); 25.7% vs. 40.7% (P = 0.147); 32.8% vs. 44.4% (P = 0.28), respectively. In a secondary pre-specified time-to-event analysis no differences were observed in admission for acute decompensated HF between patients treated with levosimendan compared with placebo (hazard ratio 0.66; 95% CI, 0.32-1.32; P = 0.24). Cumulative incidence for the aggregated endpoint of acute decompensation of HF and/or death at 1 and 3 months were significatively lower in the levosimendan group than in placebo group [5.7% vs. 25.9% (P = 0.004) and 17.1% vs. 48.1% (P = 0.001), respectively], but not at 6 and 12 months [34.2% vs. 59.2% (P = 0.025); 41.4% vs. 66.6% (P = 0.022), respectively]. Survival probability was significantly higher in patients who received levosimendan compared with those who received placebo (log rank: 4.06; P = 0.044). There were no clinically relevant differences in tolerability between levosimendan and placebo and no new safety signals were observed. Conclusions: In our study, intermittent levosimendan in patients with AdHF produced a statistically non-significant reduction in the incidence of hospital readmissions for acute decompensated HF, a significantly lower cumulative incidence of acute decompensation of HF and/or death at 1 and 3 month of treatment and a significant improvement in survival during 12 months of treatment.
  • dc.format.mimetype application/pdf
  • dc.identifier.citation García-González MJ, Aldea Perona A, Lara Padron A, Morales Rull JL, Martínez-Sellés M, de Mora Martin M, et al. Efficacy and safety of intermittent repeated levosimendan infusions in advanced heart failure patients: the LAICA study. ESC Heart Fail. 2021 Dec; 8(6): 4820-31. DOI: 10.1002/ehf2.13670
  • dc.identifier.doi http://dx.doi.org/10.1002/ehf2.13670
  • dc.identifier.issn 2055-5822
  • dc.identifier.uri http://hdl.handle.net/10230/53359
  • dc.language.iso eng
  • dc.publisher Wiley
  • dc.rights Copyright © 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
  • dc.rights.accessRights info:eu-repo/semantics/openAccess
  • dc.rights.uri http://creativecommons.org/licenses/by-nc/4.0/
  • dc.subject.keyword Advanced heart failure
  • dc.subject.keyword Inodilator
  • dc.subject.keyword Intermittent administration
  • dc.subject.keyword Levosimendan
  • dc.subject.keyword Rehospitalization
  • dc.title Efficacy and safety of intermittent repeated levosimendan infusions in advanced heart failure patients: the LAICA study
  • dc.type info:eu-repo/semantics/article
  • dc.type.version info:eu-repo/semantics/publishedVersion

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