RT Journal Article
T1 Repetitive use of levosimendan in advanced heart failure: need for stronger evidence in a field in dire need of a useful therapy.
A1 Pölzl, Gerhard
A1 Altenberger, Johann
A1 Baholli, Loant
A1 Beltrán, Paola
A1 Borbély, Attila
A1 Comin-Colet, Josep
A1 Delgado, Juan F
A1 Fedele, Francesco
A1 Fontana, Antonella
A1 Fruhwald, Friedrich
A1 Giamouzis, Gregory
A1 Giannakoulas, George
A1 Garcia-González, Martín J
A1 Gustafsson, Finn
A1 Kaikkonen, Kari
A1 Kivikko, Matti
A1 Kubica, Jacek
A1 von Lewinski, Dirk
A1 Löfman, Ida
A1 Malfatto, Gabriella
A1 Manito, Nicolás
A1 Martínez-Sellés, Martin
A1 Masip, Josep
A1 Merkely, Bela
A1 Morandi, Fabrizio
A1 Mølgaard, Henning
A1 Oliva, Fabrizio
A1 Pantev, Emil
A1 Papp, Zoltán
A1 Perna, Gian Piero
A1 Pfister, Roman
A1 Piazza, Vito
A1 Bover, Ramón
A1 Rangel-Sousa, Diego
A1 Recio-Mayoral, Alejandro
A1 Reinecke, Alexander
A1 Rieth, Andreas
A1 Sarapohja, Toni
A1 Schmidt, Gunter
A1 Seidel, Mirko
A1 Störk, Stefan
A1 Vrtovec, Bojan
A1 Wikström, Gerhard
A1 Yerly, Patrik
A1 Pollesello, Piero
K1 Advanced heart failure
K1 Clinical trial
K1 Composite end-point
K1 Intermittent
K1 Levosimendan
K1 Repetitive
AB 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.
YR 2017
FD 2017-05-23
LK http://hdl.handle.net/10668/11256
UL http://hdl.handle.net/10668/11256
LA en
DS RISalud
RD Apr 18, 2025