Poelzl, Gerhard, Altenberger, Johann, Baholli, Loant, Beltran, Paola, Borbely, Attila, Comin-Colet, Josep, Delgado, Juan F. ORCID: 0000-0002-5401-8324, Fedele, Francesco, Fontana, Antonella, Fruhwald, Friedrich, Giamouzis, Gregory, Giannakoulas, George ORCID: 0000-0001-7491-6319, Garcia-Gonzalez, Martin J., Gustafsson, Finn ORCID: 0000-0003-2144-341X, Kaikkonen, Kari, Kivikko, Matti, Kubica, Jacek ORCID: 0000-0001-8250-754X, von Lewinski, Dirk, Lofman, Ida, Malfatto, Gabriella, Manito, Nicolas, Martinez-Selles, Martin, Masip, Josep, Merkely, Bela, Morandi, Fabrizio, Molgaard, Henning, Oliva, Fabrizio, Pantev, Emil, Papp, Zoltan, Perna, Gian Piero, Pfister, Roman, Piazza, Vito, Bover, Ramon, Rangel-Sousa, Diego, Recio-Mayoral, Alejandro, Reinecke, Alexander, Rieth, Andreas, Sarapohja, Toni, Schmidt, Gunter, Seidel, Mirko, Stoerk, Stefan, Vrtovec, Bojan, Wikstroem, Gerhard, Yerly, Patrik and Pollesello, Piero ORCID: 0000-0001-6994-768X (2017). Repetitive use of levosimendan in advanced heart failure: need for stronger evidence in a field in dire need of a useful therapy. Int. J. Cardiol., 243. S. 389 - 396. CLARE: ELSEVIER IRELAND LTD. ISSN 1874-1754

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Abstract

Patients in the latest stages of heart failure are severely compromised, with poor quality of life and frequent hospitalizations. Heart transplantation and left ventricular assist device implantation are viable options only for a minority, and intermittent or continuous infusions of positive inotropes may be needed as a bridge therapy or as a symptomatic approach. In these settings, levosimendan has potential advantages over conventional inotropes (catecholamines and phosphodiesterase inhibitors), such as sustained effects after initial infusion, synergy with beta-blockers, and no increase in oxygen consumption. Levosimendan has been suggested as a treatment that reduces re-hospitalization and improves quality of life. However, previous clinical studies of intermittent infusions of levosimendan were not powered to show statistical significance on key outcome parameters. A panel of 45 expert clinicians from 12 European countries met in Rome on November 24-25, 2016 to review the literature and envision an appropriately designed clinical trial addressing these needs. In the earlier FIGHT trial (daily subcutaneous injection of liraglutide in heart failure patients with reduced ejection fraction) a composite Global Rank Score was used as primary end-point where death, re-hospitalization, and change in N-terminalprohormone-brain natriuretic peptide level were considered in a hierarchical order. In the present study, we tested the same end-point post hoc in the PERSIST and LEVOREP trials on oral and repeated i.v. levosimendan, respectively, and demonstrated superiority of levosimendan treatment vs placebo. The use of the same composite end-point in a properly powered study on repetitive levosimendan in advanced heart failure is strongly advocated. (C) 2017 The Authors. Published by Elsevier Ireland Ltd.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Poelzl, GerhardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Altenberger, JohannUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baholli, LoantUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Beltran, PaolaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Borbely, AttilaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Comin-Colet, JosepUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Delgado, Juan F.UNSPECIFIEDorcid.org/0000-0002-5401-8324UNSPECIFIED
Fedele, FrancescoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fontana, AntonellaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fruhwald, FriedrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Giamouzis, GregoryUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Giannakoulas, GeorgeUNSPECIFIEDorcid.org/0000-0001-7491-6319UNSPECIFIED
Garcia-Gonzalez, Martin J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gustafsson, FinnUNSPECIFIEDorcid.org/0000-0003-2144-341XUNSPECIFIED
Kaikkonen, KariUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kivikko, MattiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kubica, JacekUNSPECIFIEDorcid.org/0000-0001-8250-754XUNSPECIFIED
von Lewinski, DirkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lofman, IdaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Malfatto, GabriellaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Manito, NicolasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Martinez-Selles, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Masip, JosepUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Merkely, BelaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Morandi, FabrizioUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Molgaard, HenningUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Oliva, FabrizioUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pantev, EmilUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Papp, ZoltanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Perna, Gian PieroUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pfister, RomanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Piazza, VitoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bover, RamonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rangel-Sousa, DiegoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Recio-Mayoral, AlejandroUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reinecke, AlexanderUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rieth, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sarapohja, ToniUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmidt, GunterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Seidel, MirkoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stoerk, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vrtovec, BojanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wikstroem, GerhardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Yerly, PatrikUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pollesello, PieroUNSPECIFIEDorcid.org/0000-0001-6994-768XUNSPECIFIED
URN: urn:nbn:de:hbz:38-217721
DOI: 10.1016/j.ijcard.2017.05.081
Journal or Publication Title: Int. J. Cardiol.
Volume: 243
Page Range: S. 389 - 396
Date: 2017
Publisher: ELSEVIER IRELAND LTD
Place of Publication: CLARE
ISSN: 1874-1754
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
INTRAVENOUS LEVOSIMENDAN; LONG-TERM; VENTRICULAR FUNCTION; EUROPEAN-SOCIETY; DOUBLE-BLIND; FOLLOW-UP; INTERMITTENT; INFUSIONS; EFFICACY; SAFETYMultiple languages
Cardiac & Cardiovascular SystemsMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/21772

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