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1. Levosimendan beyond inotropy and acute heart failure: Evidence of pleiotropic effects on the heart and other organs: An expert panel position paper

Author

Farmakis, Dimitrios, Alvarez, Julian, Ben Gal, Tuvia, Brito, Dulce, Fedele, Francesco, Fonseca, Candida, Gordon, Anthony C., Gotsman, Israel, Grossini, Elena, Guarracino, Fabio, Harjola, Veli-Pekka, Hellman, Yaron, Heunks, Leo, Ivancan, Visnja, Karavidas, Apostolos, Kivikko, Matti, Lomivorotov, Vladimir, Longrois, Dan, Masip, Josep, Metra, Marco, Morelli, Andrea, Nikolaou, Maria, Papp, Zoltan, Parkhomenko, Alexander, Poelzl, Gerhard, Pollesello, Piero, Ravn, Hanne Berg, Rex, Steffen, Riha, Hynek, Ricksten, Sven-Erik, Schwinger, Robert H. G., Vrtovec, Bojan, Yilmaz, M. Birhan, Zielinska, Marzenna, Parissis, John, Clinicum, Anestesiologian yksikkö, Department of Diagnostics and Therapeutics, [Farmakis, Dimitrios -- Parissis, John] Univ Athens, Univ Athens, Dept Cardiol, Heart Failure Unit,Univ Attikon, Athens, Greece -- [Alvarez, Julian] Univ Santiago Compostela, Dept Anesthesia, Santiago De Compostela, Spain -- [Alvarez, Julian] Univ Santiago Compostela, Surg ICU, Santiago De Compostela, Spain -- [Ben Gal, Tuvia] Rabin Med Ctr, Cardiol Clin, Petah Tiqwa, Israel -- [Brito, Dulce] Hosp Santa Maria, Dept Cardiol, Ctr Hosp Lisboa Norte, Lisbon, Portugal -- [Fedele, Francesco] Sapienza Univ Rome, Dept Cardiovasc Resp Nephrol Anesthesiol & Geriat, Rome, Italy -- [Fonseca, Candida] Univ Nova Lisboa, Heart Failure Unit, Dept Internal Med,NOVA Med Sch,Fac Ciencias Med, Hosp Sao Francico Xavier,Ctr Hosp Lisbo Ocidental, Lisbon, Portugal -- [Gordon, Anthony C.] Imperial Coll London, Sect Anaesthet Pain Med & Intens Care, London, England -- [Gotsman, Israel] Hadassah Univ Hosp Jerusalem, Inst Heart, Cardiol Clin, Jerusalem, Israel -- [Grossini, Elena] Univ East Piedmont, Physiol Lab, Novara, Italy -- [Guarracino, Fabio] Azienda Osped Univ Pisana, Dept Anaesthesia & Crit Care Med Cardiothorac Ana, Pisa, Italy -- [Harjola, Veli-Pekka] Univ Helsinki, Helsinki Univ Hosp, Emergency Med, Helsinki, Finland -- [Hellman, Yaron] Carmel Hosp, Heart Failure Serv, Haifa, Israel -- [Heunks, Leo] Radboud Univ Nijmegen, Med Ctr, Dept Intens Care, Nijmegen, Netherlands -- [Ivancan, Visnja] Univ Hosp Ctr, Emergency Cardiol Dept, Zagreb, Croatia -- [Karavidas, Apostolos] G Gennimatas Gen Hosp, Dept Cardiol, Athens, Greece -- [Kivikko, Matti -- Pollesello, Piero] Orion Pharma, Crit Care Proprietary Prod, Espoo, Finland -- [Lomivorotov, Vladimir] State Res Inst Circulat Pathol, Dept Anesthesiol & Intens Care, Novosibirsk, Russia -- [Longrois, Dan] Univ Paris Diderot, Hop Uiversitaires Paris Nord Val Seine, Hop Bichat Claude Bernard, Dept Anesthesie Reanimat Chirurg, Paris, France -- [Masip, Josep] Hosp St Joan Despi Moises Broggi, Intens Care Unit, Barcelona, Spain -- [Metra, Marco] Univ & Civil Hosp, Cardiol Clin, Brescia, Italy -- [Morelli, Andrea] Univ Roma La Sapienza, Dept Anesthesiol & Intens Care, Policlin Umberto 1, Rome, Italy -- [Nikolaou, Maria] Sismanoglio & Amalia Fleming Gen Hosp, Dept Cardiol, Athens, Greece -- [Papp, Zoltan] Univ Debrecen, Fac Med, Dept Cardiol, Div Clin Physiol, Debrecen, Hungary -- [Parkhomenko, Alexander] Inst Cardiol, Dept Anesthesiol, Kiev, Ukraine -- [Parkhomenko, Alexander] Inst Cardiol, Intens Care Unit Cardiac Surg Patients, Kiev, Ukraine -- [Poelzl, Gerhard] Univ Klin Innsbruck, Innere Med 3, Innsbruck, Austria -- [Ravn, Hanne Berg] Rigshosp, Ctr Heart, Dept Cardiothorac Anaesthesia, Copenhagen, Denmark -- [Rex, Steffen] Univ Leuven, Dept Cardiovasc Sci, Leuven, Belgium -- [Riha, Hynek] Inst Clin & Expt Med, Dept Anaesthesiol & Intens Care Med, Cardiothorac Anaesthesiol & Intens Care, Prague, Czech Republic -- [Ricksten, Sven-Erik] Univ Gothenburg, Sahlgrenska Univ Hosp, Inst Clin Sci, Dept Anesthesiol & Intens Care Med, Gothenburg, Sweden -- [Schwinger, Robert H. G.] Klinikum Weiden, Med Klin 2, Weiden, Germany -- [Vrtovec, Bojan] Univ Clin Ctr Ljubljana, Dept Cardiol, Ljubljana, Slovenia -- [Yilmaz, M. Birhan] Cumhuriyet Univ, Dept Cardiol, Sivas, Turkey -- [Zielinska, Marzenna] Med Univ Lodz, Dept Intens Cardiac Therapy, Lodz, Poland, Brito, Dulce Alves -- 0000-0003-1278-1847, Lomivorotov, Vladimir -- 0000-0001-8591-6461, Pollesello, Piero -- 0000-0001-6994-768X, YILMAZ, Mehmet Birhan -- 0000-0002-8169-8628, Zielinska, Marzenna -- 0000-0002-0118-8610, Gordon, Anthony -- 0000-0002-0419-547X, YILMAZ, MEHMET BIRHAN -- 0000-0002-8169-8628, Alvarez, Julian -- 0000-0002-2518-0891, MORELLI, ANDREA -- 0000-0001-6065-1006, Riha, Hynek -- 0000-0002-9861-7361, Gotsman, Israel -- 0000-0001-9608-2298, and Rex, Steffen -- 0000-0002-3536-9321

Subjects
Levosimendan, 3121 General medicine, internal medicine and other clinical medicine, Inotropes, education, Heart failure, Cardioprotection, Cardiogenic shock, Organ protection
Abstract

WOS: 000384698300056, PubMed ID: 27498374, Levosimendan is a positive inotrope with vasodilating properties (inodilator) indicated for decompensated heart failure (HF) patients with low cardiac output. Accumulated evidence supports several pleiotropic effects of levosimendan beyond inotropy, the heart and decompensated HF. Those effects are not readily explained by cardiac function enhancement and seem to be related to additional properties of the drug such as anti-inflammatory, anti-oxidative and anti-apoptotic ones. Mechanistic and proof-of-concept studies are still required to clarify the underlying mechanisms involved, while properly designed clinical trials are warranted to translate preclinical or early-phase clinical data into more robust clinical evidence. The present position paper, derived by a panel of 35 experts in the field of cardiology, cardiac anesthesiology, intensive care medicine, cardiac physiology, and cardiovascular pharmacology from 22 European countries, compiles the existing evidence on the pleiotropic effects of levosimendan, identifies potential novel areas of clinical application and defines the corresponding gaps in evidence and the required research efforts to address those gaps. (C) 2016 The Authors. Published by Elsevier Ireland Ltd., Orion Pharma Oyj/Abp (Finland); Medis d.o.o. (Croatia); Biomed JR Ltd. (Israel); TENAX Therapeutics Ltd. (U.S.A.), This project did not receive any financial support, apart from unrestricted grants by Orion Pharma Oyj/Abp (Finland), Medis d.o.o. (Croatia), Biomed JR Ltd. (Israel), and TENAX Therapeutics Ltd. (U.S.A.) that covered the logistic expenses related to the consensus meeting in Athens on Feb. 26-27, 2016. The attendees did not receive any honoraria. P.P. and M.K. are employees of Orion Pharma.

Published
2016

2. Renal Effects of Levosimendan: A Consensus Report

Author

Yilmaz, Mehmet B., Grossini, Elena, Silva Cardoso, Jose C., Edes, Istvan, Fedele, Francesco, Pollesello, Piero, Kivikko, Matti, Harjola, Veli-Pekka, Hasslacher, Julia, Mebazaa, Alexandre, Morelli, Andrea, le Noble, Jos, Oldner, Anders, Oulego Erroz, Ignacio, Parissis, John T., Parkhomenko, Alexander, Poelzl, Gerhard, Rehberg, Sebastian, Ricksten, Sven-Erik, Rodriguez Fernandez, Luis M., Salmenpera, Markku, Singer, Mervyn, Treskatsch, Sascha, Vrtovec, Bojan, Wikstrom, Gerhard, [Yilmaz, Mehmet B.] Cumhuriyet Univ, Sch Med, Dept Cardiol, Sivas, Turkey -- [Grossini, Elena] Univ Piemonte Orientale, Lab Fisiol, Dipartimento Med Traslaz, Piemonte, Italy -- [Silva Cardoso, Jose C.] Univ Porto, Fac Med, P-4100 Oporto, Portugal -- [Edes, Istvan] Univ Debrecen, Inst Cardiol, Med & Hlth Sci Ctr, H-4012 Debrecen, Hungary -- [Fedele, Francesco -- Morelli, Andrea] Univ Roma La Sapienza, Dept Cardiovasc Resp Nephrol & Geriatr Sci, I-00185 Rome, Italy -- [Pollesello, Piero -- Kivikko, Matti] Orion Pharma, Cardiol & Crit Care, Espoo, Finland -- [Harjola, Veli-Pekka] Helsinki Univ Hosp, Dept Cardiol, Helsinki, Finland -- [Hasslacher, Julia] Univ Klin Innere Med, Innsbruck, Austria -- [Mebazaa, Alexandre] Univ Paris, Dept Anaesthesia & Intens Care, INSERM UMR 942, Lariboisiere Hosp, F-75252 Paris, France -- [le Noble, Jos] VieCuri Med Ctr, Dept Intens Care, Venlo, Netherlands -- [Oldner, Anders] Karolinska Inst, Dept Physiol & Pharmacol, Sect Anaesthesiol & Intens CareMed, Stockholm, Sweden -- [Oulego Erroz, Ignacio -- Rodriguez Fernandez, Luis M.] Complejo Asistencial Univ Leon, Dept Pediat, Leon, Spain -- [Parissis, John T.] Attikon Univ Hosp, Heart Failure Unit, Athens, Greece -- [Parkhomenko, Alexander] Natl Sci Ctr, Strazhesko Inst Cardiol, Kiev, Ukraine -- [Poelzl, Gerhard] Med Univ Innsbruck, Dept Cardiol, A-6020 Innsbruck, Austria -- [Rehberg, Sebastian] Univ Munster, Dept Anesthesiol Intens Care & Pain Med, D-48149 Munster, Germany -- [Ricksten, Sven-Erik] Sahlgrens Univ Hosp, Dept Cardiothorac Anesthesia & Intens Care, Gothenburg, Sweden -- [Salmenpera, Markku] Helsinki Univ Hosp, Dept Anesthesiol & Intens Care Med, Helsinki, Finland -- [Singer, Mervyn] UCL, London, England -- [Treskatsch, Sascha] Charite, Dept Anesthesiol & Intens Care Med, Campus Charite Mitte, D-13353 Berlin, Germany -- [Treskatsch, Sascha] Campus Virchow Klinikum, Berlin, Germany -- [Vrtovec, Bojan] Univ Ljubljana, Med Ctr, Adv Heart Failure & Transplantat Ctr, Dept Cardiol, Ljubljana 61000, Slovenia -- [Wikstrom, Gerhard] Uppsala Univ, Akad Sjukhuset, Kardiologkliniken, Uppsala, Sweden, MORELLI, ANDREA -- 0000-0001-6065-1006, YILMAZ, Mehmet Birhan -- 0000-0002-8169-8628, YILMAZ, MEHMET BIRHAN -- 0000-0002-8169-8628, Oldner, Anders -- 0000-0003-1600-9221, Pollesello, Piero -- 0000-0001-6994-768X, Silva-Cardoso, Jose -- 0000-0002-9774-9864, CINTESIS -- 0000-0001-7248-2086, Singer, Mervyn -- 0000-0002-1042-6350, Vacca, Giovanni -- 0000-0002-0864-1887, Grossini, Elena -- 0000-0002-3012-259X, and Mebazaa, Alexandre -- 0000-0001-8715-7753

Subjects
Levosimendan, Renal dysfunction
Abstract

WOS: 000327094600012, PubMed ID: 23929366, Renal dysfunction is common in clinical settings in which cardiac function is compromised such as heart failure, cardiac surgery or sepsis, and is associated with high morbidity and mortality. Levosimendan is a calcium sensitizer and potassium channel opener used in the treatment of acute heart failure. This review describes the effects of the inodilator levosimendan on renal function. A panel of 25 scientists and clinicians from 15 European countries (Austria, Finland, France, Hungary, Germany, Greece, Italy, Portugal, the Netherlands, Slovenia, Spain, Sweden, Turkey, the United Kingdom, and Ukraine) convened and reached a consensus on the current interpretation of the renal effects of levosimendan described both in non-clinical research and in clinical study reports. Most reports on the effect of levosimendan indicate an improvement of renal function in heart failure, sepsis and cardiac surgery settings. However, caution should be applied as study designs differed from randomized, controlled studies to uncontrolled ones. Importantly, in the largest HF study (REVIVE I and II) no significant changes in the renal function were detected. As it regards the mechanism of action, the opening of mitochondrial K-ATP channels by levosimendan is involved through a preconditioning effect. There is a strong rationale for randomized controlled trials seeking beneficial renal effects of levosimendan. As an example, a study is shortly to commence to assess the role of levosimendan for the prevention of acute organ dysfunction in sepsis (LeoPARDS).

Published
2013

3. Levosimendan: Molecular mechanisms and clinical implications Consensus of experts on the mechanisms of action of levosimendan

Author

Papp, Zoltan, Edes, Istvan, Fruhwald, Sonja, De Hert, Stefan G., Salmenpera, Markku, Leppikangas, Heli, Mebazaa, Alexandre, Landoni, Giovanni, Grossini, Elena, Caimmi, Philippe, Morelli, Andrea, Guarracino, Fabio, Schwinger, Robert H. G., Meyer, Sven, Algotsson, Lars, Wikstrom, Bernt Gerhard, Jorgensen, Kirsten, Filippatos, Gerasimos, Parissis, John T., Garcia Gonzalez, Martin J., Parkhomenko, Alexander, Yilmaz, Mehmet Birhan, Kivikko, Matti, Pollesello, Piero, Follath, Ferenc, [Papp, Zoltan -- Edes, Istvan] Univ Debrecen, Inst Cardiol, Med & Hlth Sci Ctr, H-4032 Debrecen, Hungary -- [Fruhwald, Sonja] Dept Anesthesiol & Intens Care Med, Div Anesthesiol Cardiovasc Surg & Intens Care Med, A-8036 Graz, Austria -- [De Hert, Stefan G.] Univ Ghent, Ghent Univ Hosp, Dept Anesthesiol, B-9000 Ghent, Belgium -- [Salmenpera, Markku] Helsinki Univ Hosp, Dept Anesthesiol & Intens Care Med, Helsinki, Finland -- [Leppikangas, Heli] Tampere Univ Hosp, Dept Anesthesiol, Tampere, Finland -- [Mebazaa, Alexandre] Univ Paris 07, INSERM, Lariboisiere Hosp, Dept Anaesthesia & Intens Care,UMR 942, Paris, France -- [Landoni, Giovanni] Univ Vita Salute San Raffaele, Dept Anesthesiol & Intens Care, Milan, Italy -- [Grossini, Elena] Univ E Piedmont Avogadro, Dept Clin & Expt Med, Novara, Italy -- [Caimmi, Philippe] Univ E Piedmont Avogadro, Sch Med, Osped Maggiore della Carita, Dept Cardiac Surg, Novara, Italy -- [Morelli, Andrea] Univ Rome, Dept Anesthesiol & Intens Care, Rome, Italy -- [Guarracino, Fabio] Univ Hosp Pisa, Cardiothorac Dept, Cardiothorac Anaesthesia & Intens Care Unit, Pisa, Italy -- [Schwinger, Robert H. G.] Teaching Hosp Univ Regensburg, Klinikum Weiden, Clin Internal Med 2, D-92637 Weiden, Germany -- [Meyer, Sven] Univ Med Ctr Hamburg Eppendorf, Univ Heart Ctr Hamburg, Dept Gen & Intervent Cardiol, D-20246 Hamburg, Germany -- [Algotsson, Lars] Lund Univ, Fac Med, Dept Anesthesiol & Intens Care, Lund, Sweden -- [Wikstrom, Bernt Gerhard] Akad Hosp, Dept Med Sci, SE-75185 Uppsala, Sweden -- [Jorgensen, Kirsten] Sahlgrens Univ Hosp, Dept Cardiothorac Anesthesia & Intens Care, S-41345 Gothenburg, Sweden -- [Filippatos, Gerasimos] Attikon Univ Hosp, Dept Cardiol 2, Athens, Greece -- [Filippatos, Gerasimos -- Parissis, John T.] Attikon Univ Hosp, Heart Failure Unit, Athens, Greece -- [Garcia Gonzalez, Martin J.] Hosp Univ Canarias, Dept Cardiol, Coronary Care Unit, Tenerife, Spain -- [Parkhomenko, Alexander] Natl Sci Ctr, Strazhesko Inst Cardiol, Kiev, Ukraine -- [Yilmaz, Mehmet Birhan] Cumhuriyet Univ, Sch Med, Dept Cardiol, Sivas, Turkey -- [Kivikko, Matti] Orion Pharma, Med Affairs, FIN-02101 Espoo, Finland -- [Pollesello, Piero] Orion Pharma, Cardiol & Crit Care, FIN-02101 Espoo, Finland -- [Follath, Ferenc] Univ Zurich Hosp, Off HAL 18 D2, CH-8091 Zurich, Switzerland, MORELLI, ANDREA -- 0000-0001-6065-1006, YILMAZ, Mehmet Birhan -- 0000-0002-8169-8628, Pollesello, Piero -- 0000-0001-6994-768X, YILMAZ, MEHMET BIRHAN -- 0000-0002-8169-8628, LANDONI, Giovanni -- 0000-0002-8594-5980, Grossini, Elena -- 0000-0002-3012-259X, Mebazaa, Alexandre -- 0000-0001-8715-7753, Guarracino, Fabio -- 0000-0002-2562-0199, and Vacca, Giovanni -- 0000-0002-0864-1887

Subjects
Vasodilation, Ca2+-sensitization, Levosimendan, Positive inotropy, Cardioprotection, Mechanism of action
Abstract

WOS: 000307827100011, PubMed ID: 21784540, The molecular background of the Ca2+-sensitizing effect of levosimendan relates to its specific interaction with the Ca2+-sensor troponin C molecule in the cardiac myofilaments. Over the years, significant preclinical and clinical evidence has accumulated and revealed a variety of beneficial pleiotropic effects of levosimendan and of its long-lived metabolite, OR-1896. First of all, activation of ATP-sensitive sarcolemmal K+ channels of smooth muscle cells appears as a powerful vasodilator mechanism. Additionally, activation of ATP-sensitive K+ channels in the mitochondria potentially extends the range of cellular actions towards the modulation of mitochondrial ATP production and implicates a pharmacological mechanism for cardioprotection. Finally, it has become evident, that levosimendan possesses an isoform-selective phosphodiesterase-inhibitory effect. Interpretation of the complex mechanism of levosimendan action requires that all potential pharmacological interactions are analyzed carefully in the framework of the currently available evidence. These data indicate that the cardiovascular effects of levosimendan are exerted via more than an isolated drug-receptor interaction, and involve favorable energetic and neurohormonal changes that are unique in comparison to other types of inodilators. (C) 2011 Elsevier Ireland Ltd. All rights reserved.

Published
2012

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