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Pölzl, G; Altenberger, J; Baholli, L; Beltrán, P; Borbély, A; Comin-Colet, J; Delgado, JF; Fedele, F; Fontana, A; Fruhwald, F; Giamouzis, G; Giannakoulas, G; Garcia-González, MJ; Gustafsson, F; Kaikkonen, K; Kivikko, M; Kubica, J; von Lewinski, D; Löfman, I; Malfatto, G; Manito, N; Martínez-Sellés, M; Masip, J; Merkely, B; Morandi, F; Mølgaard, H; Oliva, F; Pantev, E; Papp, Z; Perna, GP; Pfister, R; Piazza, V; Bover, R; Rangel-Sousa, D; Recio-Mayoral, A; Reinecke, A; Rieth, A; Sarapohja, T; Schmidt, G; Seidel, M; Störk, S; Vrtovec, B; Wikström, G; Yerly, P; Pollesello, P.
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. 2017; 243(3):389-395 Doi: 10.1016/j.ijcard.2017.05.081 [OPEN ACCESS]
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Co-Autor*innen der Med Uni Graz
Fruhwald Friedrich
von Lewinski Dirk

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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-terminal-prohormone-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. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.
Find related publications in this database (using NLM MeSH Indexing)
Administration, Oral -
Cardiotonic Agents - administration & dosage
Clinical Trials as Topic - methods
Clinical Trials as Topic - standards
Consensus Development Conferences as Topic -
Drug Administration Schedule -
Europe - epidemiology
Evidence-Based Medicine - standards
Evidence-Based Medicine - trends
Heart Failure - diagnosis
Heart Failure - drug therapy
Heart Failure - epidemiology
Humans -
Hydrazones - administration & dosage
Infusions, Intravenous -
Pyridazines - administration & dosage
Rome - epidemiology
Simendan -

Find related publications in this database (Keywords)
Advanced heart failure
Clinical trial
Composite end-point
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