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Overview of the current use of levosimendan in France: a prospective observational cohort study
BACKGROUND: Following the results of randomized controlled trials on levosimendan, French health authorities requested an update of the current use and side-effects of this medication on a national scale. METHOD: The France-LEVO registry was a prospective observational cohort study reflecting the in...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10409690/ https://www.ncbi.nlm.nih.gov/pubmed/37552372 http://dx.doi.org/10.1186/s13613-023-01164-3 |
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author | Cholley, Bernard Bojan, Mirela Guillon, Benoit Besnier, Emmanuel Mattei, Mathieu Levy, Bruno Ouattara, Alexandre Tafer, Nadir Delmas, Clément Tonon, David Rozec, Bertrand Fellahi, Jean-Luc Lim, Pascal Labaste, François Roubille, François Caruba, Thibaut Mauriat, Philippe |
author_facet | Cholley, Bernard Bojan, Mirela Guillon, Benoit Besnier, Emmanuel Mattei, Mathieu Levy, Bruno Ouattara, Alexandre Tafer, Nadir Delmas, Clément Tonon, David Rozec, Bertrand Fellahi, Jean-Luc Lim, Pascal Labaste, François Roubille, François Caruba, Thibaut Mauriat, Philippe |
author_sort | Cholley, Bernard |
collection | PubMed |
description | BACKGROUND: Following the results of randomized controlled trials on levosimendan, French health authorities requested an update of the current use and side-effects of this medication on a national scale. METHOD: The France-LEVO registry was a prospective observational cohort study reflecting the indications, dosing regimens, and side-effects of levosimendan, as well as patient outcomes over a year. RESULTS: The patients included (n = 602) represented 29.6% of the national yearly use of levosimendan in France. They were treated for cardiogenic shock (n = 250, 41.5%), decompensated heart failure (n = 127, 21.1%), cardiac surgery-related low cardiac output prophylaxis and/or treatment (n = 86, 14.3%), and weaning from veno-arterial extracorporeal membrane oxygenation (n = 82, 13.6%). They received 0.18 ± 0.07 µg/kg/min levosimendan over 26 ± 8 h. An initial bolus was administered in 45 patients (7.5%), 103 (17.1%) received repeated infusions, and 461 (76.6%) received inotropes and or vasoactive agents concomitantly. Hypotension was reported in 218 patients (36.2%), atrial fibrillation in 85 (14.1%), and serious adverse events in 17 (2.8%). 136 patients (22.6%) died in hospital, and 26 (4.3%) during the 90-day follow-up. CONCLUSIONS: We observed that levosimendan was used in accordance with recent recommendations by French physicians. Hypotension and atrial fibrillation remained the most frequent side-effects, while serious adverse event potentially attributable to levosimendan were infrequent. The results suggest that this medication was safe and potentially associated with some benefit in the population studied. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13613-023-01164-3. |
format | Online Article Text |
id | pubmed-10409690 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-104096902023-08-10 Overview of the current use of levosimendan in France: a prospective observational cohort study Cholley, Bernard Bojan, Mirela Guillon, Benoit Besnier, Emmanuel Mattei, Mathieu Levy, Bruno Ouattara, Alexandre Tafer, Nadir Delmas, Clément Tonon, David Rozec, Bertrand Fellahi, Jean-Luc Lim, Pascal Labaste, François Roubille, François Caruba, Thibaut Mauriat, Philippe Ann Intensive Care Research BACKGROUND: Following the results of randomized controlled trials on levosimendan, French health authorities requested an update of the current use and side-effects of this medication on a national scale. METHOD: The France-LEVO registry was a prospective observational cohort study reflecting the indications, dosing regimens, and side-effects of levosimendan, as well as patient outcomes over a year. RESULTS: The patients included (n = 602) represented 29.6% of the national yearly use of levosimendan in France. They were treated for cardiogenic shock (n = 250, 41.5%), decompensated heart failure (n = 127, 21.1%), cardiac surgery-related low cardiac output prophylaxis and/or treatment (n = 86, 14.3%), and weaning from veno-arterial extracorporeal membrane oxygenation (n = 82, 13.6%). They received 0.18 ± 0.07 µg/kg/min levosimendan over 26 ± 8 h. An initial bolus was administered in 45 patients (7.5%), 103 (17.1%) received repeated infusions, and 461 (76.6%) received inotropes and or vasoactive agents concomitantly. Hypotension was reported in 218 patients (36.2%), atrial fibrillation in 85 (14.1%), and serious adverse events in 17 (2.8%). 136 patients (22.6%) died in hospital, and 26 (4.3%) during the 90-day follow-up. CONCLUSIONS: We observed that levosimendan was used in accordance with recent recommendations by French physicians. Hypotension and atrial fibrillation remained the most frequent side-effects, while serious adverse event potentially attributable to levosimendan were infrequent. The results suggest that this medication was safe and potentially associated with some benefit in the population studied. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13613-023-01164-3. Springer International Publishing 2023-08-08 /pmc/articles/PMC10409690/ /pubmed/37552372 http://dx.doi.org/10.1186/s13613-023-01164-3 Text en © The Author(s) 2023, corrected publication 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Research Cholley, Bernard Bojan, Mirela Guillon, Benoit Besnier, Emmanuel Mattei, Mathieu Levy, Bruno Ouattara, Alexandre Tafer, Nadir Delmas, Clément Tonon, David Rozec, Bertrand Fellahi, Jean-Luc Lim, Pascal Labaste, François Roubille, François Caruba, Thibaut Mauriat, Philippe Overview of the current use of levosimendan in France: a prospective observational cohort study |
title | Overview of the current use of levosimendan in France: a prospective observational cohort study |
title_full | Overview of the current use of levosimendan in France: a prospective observational cohort study |
title_fullStr | Overview of the current use of levosimendan in France: a prospective observational cohort study |
title_full_unstemmed | Overview of the current use of levosimendan in France: a prospective observational cohort study |
title_short | Overview of the current use of levosimendan in France: a prospective observational cohort study |
title_sort | overview of the current use of levosimendan in france: a prospective observational cohort study |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10409690/ https://www.ncbi.nlm.nih.gov/pubmed/37552372 http://dx.doi.org/10.1186/s13613-023-01164-3 |
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