Levosimendan Efficacy and Safety : 20 Years of SIMDAX in Clinical Use
Abstract
Levosimendan was first approved for clinical use in 2000, when authorization was granted by Swedish regulatory authorities for the hemodynamic stabilization of patients with acutely decompensated chronic heart failure (HF). In the ensuing 20 years, this distinctive inodilator, which enhances cardiac contractility through calcium sensitization and promotes vasodilatation through the opening of adenosine triphosphate-dependent potassium channels on vascular smooth muscle cells, has been approved in more than 60 jurisdictions, including most of the countries of the European Union and Latin America. Areas of clinical application have expanded considerably and now include cardiogenic shock, takotsubo cardiomyopathy, advanced HF, right ventricular failure, pulmonary hypertension, cardiac surgery, critical care, and emergency medicine. Levosimendan is currently in active clinical evaluation in the United States. Levosimendan in IV formulation is being used as a research tool in the exploration of a wide range of cardiac and noncardiac disease states. A levosimendan oral form is at present under evaluation in the management of amyotrophic lateral sclerosis. To mark the 20 years since the advent of levosimendan in clinical use, 51 experts from 23 European countries (Austria, Belgium, Croatia, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Italy, the Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, the United Kingdom, and Ukraine) contributed to this essay, which evaluates one of the relatively few drugs to have been successfully introduced into the acute HF arena in recent times and charts a possible development trajectory for the next 20 years.
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Uppsala universitet, Kardiologi; Univ Debrecen, Fac Med, Dept Cardiol, Debrecen, Hungary.; IRCCS, Dept Clin Sci & Community Hlth, Ctr Cardiol Monzino, Milan, Italy.; Univ Santiago de Compostela, Sch Med, Dept Surg, Santiago De Compostela, Spain.; Univ Hosp Zurich, Inst Anaesthesiol, Zurich, Switzerland.; Univ Hosp, Dept Anaesthesiol, Ghent, Belgium.; Univ Lisbon, Ctr Hosp Univ Lisboa Norte, Fac Med, Cardiol Dept,CCUI, Lisbon, Portugal.; Univ JE Purkyne, Masaryk Hosp, Dept Anaesthesiol Perioperat Med & Intens Care, Usti Nad Labem, Czech Republic.; Hosp Univ Bellvitge, Heart Dis Inst, Barcelona, Spain.; Univ Coruna UDC, Complexo Hosp Univ A Coruna CHUAC, Inst Invest Biomed A Coruna Inib, CIBERCV, La Coruna, Spain.; Univ Hosp 12 Octubre, Heart Failure & Transplant Program, Cardiol Dept, Madrid, Spain.; Sechenov Univ, Petrovskii Natl Res Ctr Surg, Dept Cardiac Intens Care, Moscow, Russia.; Univ Cyprus, Med Sch, Dept Cardiol, Nicosia, Cyprus.; Sapienza Univ Rome, Dept Cardiovasc Resp Nephrol Anaesthesiol & Geria, Rome, Italy.; Sao Francisco Xavier Hosp, CHLO, Heart Failure Clin, Lisbon, Portugal.; Med Univ Graz, Dept Anaesthesiol & Intens Care Med, Div Anaesthesiol Cardiovasc Surg & Intens Care Me, Graz, Austria.; Policlin Modena, Struttura Complessa Anestesia 1, Modena, Italy.; Azienda Osped Univ Pisana, Dipartimento Anestesia & Terapie Intens, Pisa, Italy.; Univ Helsinki, Meilahti Cent Univ Hosp, Emergency Med, Helsinki, Finland.; Univ Lubeck, Dept Anaesthesiol & Intens Care Med, Lubeck, Germany.; Hop Erasme, Dept Intens Care, Brussels, Belgium.; Amsterdam UMC, Dept Intens Care Med, Amsterdam, Netherlands.; Oslo Univ Hosp Ullevaal, Dept Cardiol, Oslo, Norway.; Univ Hosp Ctr, Dept Anaesthesiol Reanimatol & Intens Care, Zagreb, Croatia.; Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden.;Sahlgrens Univ Hosp, Dept Transplantat, Gothenburg, Sweden.; Natl Hlth Serv, Intens Care Unit, Leeds, W Yorkshire, England.; Orion Pharma, R&D, Global Med Affairs, Espoo, Finland.; Nicolaus Copernicus Univ, Dept Cardiol & Internal Med, Torun, Poland.; Univ Barcelona, Intens Care Dept, Consorci Sanitari Integral, Barcelona, Spain.; Lomonosov Moscow State Univ, Med Ctr, Moscow, Russia.; St Louis & Lariboisiere Univ Hosp, AP HP, Dept Anaesthesiol & Crit Care Med, Paris, France.; Sydantutkimussaatio, Helsinki, Finland.; Osped Niguarda Ca Granda, Dept Cardiol, Milan, Italy.; Univ Szeged, Hungarian Acad Sci, MTA SZTE Res Grp Cardiovasc Pharmacol, Szeged, Hungary.; Natl & Kapodistrian Univ Athens, Attikon Univ Hosp, Dept Cardiol 2, Athens, Greece.; Natl Sci Ctr MD Strazhesko Inst Cardiol, Emergency Cardiol Dept, Kiev, Ukraine.; North Estonia Med Ctr, Dept Cardiol, Tallinn, Estonia.; Med Univ Innsbruck, Dept Internal Med Cardiol & Angiol 3, Innsbruck, Austria.; Univ Klinikum Schleswig Holstein, Kardiol, Klin Innere Med 3, Kiel, Germany.; Sahlgrens Univ Hosp, Dept Anaesthesiol & Intens Care, Gothenburg, Sweden.; Inst Clin & Expt Med, Dept Anaesthesiol & Intens Care Med Cardiothorac, Prague, Czech Republic.; Spittal Limmattal, Dept Med, Schlieren, Switzerland.; Orion Pharma, Stat Serv, R&D, Espoo, Finland.; Teaching Hosp Univ Regensburg, Klinikum Weiden, Med Klin 2, Weiden, Germany.; Med Univ Graz, Dept Anaesthesiol & Intens Care Med, Graz, Austria.; San Camillo Forlanini Hosp, Anaesthesia & Intens Care Div, Rome, Italy.; Charite Univ Med Berlin, Dept Cardiol, Campus Virchow Klinikum, Berlin, Germany.; Med Univ Graz, Dept Cardiol, Myokardiale Energet & Metabolismus Res Unit, Graz, Austria.; Univ Clin Ctr, Adv Heart Failure & Transplantat Ctr, Dept Cardiol, Ljubljana, Slovenia.; Orion Pharma, Crit Care Proprietary Prod, POB 65, FIN-02101 Espoo, Finland.; Ovid Technologies (Wolters Kluwer Health)
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