Increased Mortality after Dronedarone Therapy for Severe Heart Failure

• Published in: The New England journal of medicine Vol. 358; no. 25; pp. 2678 - 2687
• Main Authors: Køber, Lars, Torp-Pedersen, Christian, McMurray, John J.V, Gøtzsche, Ole, Lévy, Samuel, Crijns, Harry, Amlie, Jan, Carlsen, Jan
• Format: Journal Article
• Language: English
• Published: Boston, MA Massachusetts Medical Society 19.06.2008
• Subjects: Adult; Aged; Aged, 80 and over; Amiodarone - adverse effects; Amiodarone - analogs & derivatives; Amiodarone - therapeutic use; Anti-Arrhythmia Agents - adverse effects; Anti-Arrhythmia Agents - therapeutic use; Biological and medical sciences; Cardiac arrhythmia; Cardiovascular Diseases - mortality; Cause of Death; Clinical trials; Double-Blind Method; Epidemiology; Female; General aspects; Heart failure; Heart Failure - drug therapy; Heart Failure - mortality; Heart Failure - physiopathology; Humans; Kaplan-Meier Estimate; Male; Medical research; Medical sciences; MEDICIN; MEDICINE; Middle Aged; Mortality; Pharmacology; Public health. Hygiene; Public health. Hygiene-occupational medicine; Treatment Failure; Ventricular Dysfunction, Left; Antianginal agent; Heart failure; Medicine; Treatment; Sulfonamides; Heart disease; Mortality; Cardiovascular disease; Antiarrhythmic agent; Severe; Epidemiology; Dronedarone
• ISSN: 0028-4793; 1533-4406; 1533-4406
• DOI: 10.1056/NEJMoa0800456

Dronedarone is a class III antiarrhythmic drug that has efficacy as a treatment for atrial fibrillation and ventricular arrhythmias. In this clinical trial involving patients with severe heart failure, however, dronedarone was found to increase overall mortality, raising serious concern about the safety of this drug in patients with advanced heart failure. In patients with severe heart failure, dronedarone was found to increase overall mortality, raising serious concern about the safety of this drug in patients with advanced heart failure. Atrial and ventricular arrhythmias contribute to the morbidity and mortality associated with heart failure. 1 – 3 Class III antiarrhythmic agents reduce the likelihood of the development of atrial fibrillation in patients with heart failure and also increase the rate of conversion from atrial fibrillation to sinus rhythm, which may reduce the risk of acute decompensation. In a previous randomized trial involving patients with heart failure, use of one agent in this class, dofetilide, was associated with fewer hospitalizations for worsening heart failure. 4 Ventricular arrhythmias are also common in patients with heart failure and reduced systolic function and frequently lead to sudden . . .