Effect of Dronedarone on Cardiovascular Events in Atrial Fibrillation

• Published in: The New England journal of medicine Vol. 360; no. 7; pp. 668 - 678
• Main Authors: Hohnloser, Stefan H, Crijns, Harry J.G.M, van Eickels, Martin, Gaudin, Christophe, Page, Richard L, Torp-Pedersen, Christian, Connolly, Stuart J
• Format: Journal Article
• Language: English
• Published: Waltham, MA Massachusetts Medical Society 12.02.2009
• Subjects: Aged; Amiodarone - adverse effects; Amiodarone - analogs & derivatives; Amiodarone - therapeutic use; Anti-Arrhythmia Agents - adverse effects; Anti-Arrhythmia Agents - therapeutic use; Atrial Fibrillation - drug therapy; Atrial Fibrillation - mortality; Biological and medical sciences; Bradycardia - chemically induced; Cardiac arrhythmia; Cardiac dysrhythmias; Cardiology. Vascular system; Cardiovascular Diseases - mortality; Cardiovascular Diseases - prevention & control; Creatinine - blood; Data collection; Double-Blind Method; Female; Follow-Up Studies; General aspects; Heart; Hospitalization - statistics & numerical data; Humans; Kaplan-Meier Estimate; Male; Medical sciences; MEDICIN; MEDICINE; Middle Aged; Mortality; Patients; Risk Factors; Secondary Prevention; Treatment Outcome; Antianginal agent; Medicine; Arrhythmia; Sulfonamides; Heart disease; Atrial fibrillation; Cardiovascular disease; Antiarrhythmic agent; Excitability disorder; Dronedarone
• ISSN: 0028-4793; 1533-4406; 1533-4406
• DOI: 10.1056/NEJMoa0803778

The antiarrhythmic drug dronedarone was compared with placebo in 4628 patients with atrial fibrillation. At a mean follow-up of 21 months, the rate of first hospitalization due to cardiovascular events or death was significantly lower with dronedarone than with placebo. The dronedarone group had higher rates of bradycardia, QT-interval prolongation, nausea, diarrhea, rash, and increase in the serum creatinine level. The antiarrhythmic drug dronedarone was compared with placebo in patients with atrial fibrillation. At a mean follow-up of 21 months, the rate of first hospitalization due to cardiovascular events or death was significantly lower with dronedarone. Atrial fibrillation is the most common type of cardiac arrhythmia requiring medical care, with a prevalence of almost 1% in the adult population in the United States. 1 Its prevalence increases with age, affecting 3.8% of the U.S. population over 60 years of age and 9.0% of the population older than 80 years. Over the past two decades, hospitalizations for atrial fibrillation in the United States have increased by a factor of two to three, resulting in a substantial public health burden. 2 Despite advances in nonpharmacologic therapy, 3 many symptomatic patients receive medical treatment for rhythm control. Currently available antiarrhythmic agents are . . .