{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T16:20:25Z","timestamp":1791908425167,"version":"4.3.4"},"reference-count":74,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2019,7,20]],"date-time":"2019-07-20T00:00:00Z","timestamp":1563580800000},"content-version":"vor","delay-in-days":1,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Good Publication Practice"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Efficacy and safety of dronedarone was shown in the ATHENA trial for paroxysmal or persistent atrial fibrillation (AF) patients. Further trials revealed safety concerns in patients with heart failure and permanent AF. This review summarizes insights from recent real-world studies and meta-analyses, including reports on efficacy, with focus on liver safety, mortality risk in patients with paroxysmal\/persistent AF, and interactions of dronedarone with direct oral anticoagulants. Reports of rapidly progressing liver failure in dronedarone-prescribed patients in 2011 led to regulatory cautions about potential liver toxicity. Recent real-world evidence suggests dronedarone liver safety profile is similar to other antiarrhythmics and liver toxicity could be equally common with many Class III antiarrhythmics. Dronedarone safety concerns (increased mortality in patients with permanent AF) were raised based on randomized controlled trials (RCT) (ANDROMEDA and PALLAS), but comedication with digoxin may have increased the mortality rates in PALLAS, considering the dronedarone\u2013digoxin pharmacokinetic (PK) interaction. Real-world data on apixaban\u2013dronedarone interactions and edoxaban RCT observations suggest no significant safety risks for these drug combinations. Median trough plasma concentrations of dabigatran 110\u2009mg during concomitant use with dronedarone are at acceptable levels, while PK data on the rivaroxaban\u2013dronedarone interaction are unavailable. In RCTs and real-world studies, dronedarone significantly reduces AF burden and cardiovascular hospitalizations, and demonstrates a low risk for proarrhythmia in patients with paroxysmal or persistent AF. The concerns on liver safety must be balanced against the significant reduction in hospitalizations in patients with non-permanent AF and low risk for proarrhythmias following dronedarone treatment.<\/jats:p>","DOI":"10.1093\/europace\/euz193","type":"journal-article","created":{"date-parts":[[2019,6,20]],"date-time":"2019-06-20T11:10:16Z","timestamp":1561029016000},"source":"Crossref","is-referenced-by-count":17,"title":["Safety and efficacy of dronedarone from clinical trials to real-world evidence: implications for its use in atrial fibrillation"],"prefix":"10.1093","author":[{"given":"Giuseppe","family":"Boriani","sequence":"first","affiliation":[{"name":"Division of Cardiology, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Policlinico di Modena, Modena, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carina","family":"Blomstr\u00f6m-Lundqvist","sequence":"additional","affiliation":[{"name":"Department of Medical Science and Cardiology, Uppsala University, Uppsala, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan H","family":"Hohnloser","sequence":"additional","affiliation":[{"name":"Division of Clinical Electrophysiology, Department of Cardiology, J W Goethe University, Frankfurt, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lennart","family":"Bergfeldt","sequence":"additional","affiliation":[{"name":"Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden"},{"name":"V\u00e4stra G\u00f6taland, Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni L","family":"Botto","sequence":"additional","affiliation":[{"name":"ASST Rhodense, Ospedale di Circolo Rho, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Capucci","sequence":"additional","affiliation":[{"name":"Universit\u00e0 Politecnica delle Marche, Ancona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ignacio Fern\u00e1ndez","family":"Lozano","sequence":"additional","affiliation":[{"name":"Sociedad Espa\u00f1ola de Cardiolog\u00eda, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Goette","sequence":"additional","affiliation":[{"name":"Medical Clinic II, Cardiology Department, St Vincenz-Krankenhaus Paderborn, Paderborn, Germany"},{"name":"Working Group Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carsten W","family":"Israel","sequence":"additional","affiliation":[{"name":"Division of Clinical Electrophysiology, Department of Cardiology, J W Goethe University, Frankfurt, Germany"},{"name":"Clinic of Internal Medicine, Bethel-Clinic, Bielefeld, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9 L","family":"Merino","sequence":"additional","affiliation":[{"name":"Arrhythmia & Robotic EP Unit, Hospital Universitario La Paz-IdiPaz, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A John","family":"Camm","sequence":"additional","affiliation":[{"name":"Cardiology Clinical Academic Group, Molecular and Clinical Sciences Institute, St George\u2019s University of London, Cranmer Terrace, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2019,7,19]]},"reference":[{"key":"2019072004100168100_euz193-B1","doi-asserted-by":"crossref","first-page":"668","DOI":"10.1056\/NEJMoa0803778","article-title":"Effect of dronedarone on cardiovascular events in atrial fibrillation","volume":"360","author":"Hohnloser","year":"2009","journal-title":"N 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