Repetitive use of levosimendan in advanced heart failure: need for stronger evidence in a field in dire need of a useful therapy
| Autor: | Toni Sarapohja, Fabrizio Morandi, Paola Beltrán, Gerhard Pölzl, Roman Pfister, Matti Kivikko, Piero Pollesello, Johann Altenberger, Dirk von Lewinski, Mirko Seidel, Gian Piero Perna, Josep Comín-Colet, Attila Borbély, Ramón Bover, Martín J. García-González, Friedrich Fruhwald, George Giannakoulas, Loant Baholli, Martin Martínez-Sellés, Alexander Reinecke, Bojan Vrtovec, Juan F. Delgado, Gabriella Malfatto, Alejandro Recio-Mayoral, Josep Masip, Stefan Störk, Fabrizio Oliva, Gregory Giamouzis, Finn Gustafsson, Patrik Yerly, Diego Rangel-Sousa, Kari Kaikkonen, Ida Löfman, Zoltán Papp, Henning Mølgaard, Gunter Schmidt, Nicolás Manito, Antonella Fontana, Francesco Fedele, Gerhard Wikström, Vito Piazza, Emil Pantev, Béla Merkely, Jacek Kubica, Andreas Rieth |
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| Rok vydání: | 2017 |
| Předmět: |
Levosimendan
Consensus Development Conferences as Topic Advanced heart failure medicine.medical_treatment Rome VENTRICULAR FUNCTION Administration Oral INTRAVENOUS LEVOSIMENDAN 030204 cardiovascular system & hematology oral DOUBLE-BLIND 0302 clinical medicine Medicine Cardiac and Cardiovascular Systems Elméleti orvostudományok 030212 general & internal medicine Infusions Intravenous Heart transplantation Clinical Trials as Topic Evidence-Based Medicine Kardiologi Composite end-point clinical trial Orvostudományok EUROPEAN-SOCIETY Europe Pyridazines Clinical trial intermittent composite end-point TRIAL Cardiology and Cardiovascular Medicine medicine.drug medicine.medical_specialty Cardiotonic Agents LONG-TERM Intermittent administration Drug Administration Schedule Poor quality levosimendan 03 medical and health sciences Humans OF-CARDIOLOGY Intensive care medicine Simendan Heart Failure Repetitive business.industry INFUSIONS Hydrazones medicine.disease advanced heart failure repetitive cardiotonic agents clinical trials as topic drug administration schedule europe evidence-based medicine heart failure humans hydrazones infusions intravenous pyridazines rome consensus development conferences as topic cardiology and cardiovascular medicine infusions Heart failure Ventricular assist device intravenous FOLLOW-UP business |
| Zdroj: | Poelzl, G, Altenberger, J, Baholli, L, Beltran, P, Borbely, A, Comin-Colet, J, Delgado, J F, Fedele, F, Fontana, A, Fruhwald, F, Giamouzis, G, Giannakoulas, G, Garcia-Gonzalez, M J, Gustafsson, F, Kaikkonen, K, Kivikko, M, Kubica, J, von Lewinski, D, Lofman, I, Malfatto, G, Manito, N, Martinez-Selles, M, Masip, J, Merkely, B, Morandi, F, Molgaard, H, Oliva, F, Pantev, E, Papp, Z, Perna, G P, Pfister, R, Piazza, V, Bover, R, Rangel-Sousa, D, Recio-Mayoral, A, Reinecke, A, Rieth, A, Sarapohja, T, Schmidt, G, Seidel, M, Stoerk, S, Vrtovec, B, Wikstroem, G, Yerly, P & Pollesello, P 2017, ' Repetitive use of levosimendan in advanced heart failure : need for stronger evidence in a field in dire need of a useful therapy ', International Journal of Cardiology, vol. 243, pp. 389-395 . https://doi.org/10.1016/j.ijcard.2017.05.081 |
| ISSN: | 0167-5273 |
| DOI: | 10.1016/j.ijcard.2017.05.081 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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