Effect of dronedarone on cardiovascular events in atrial fibrillation.

Publication/Presentation Date

2-12-2009

Abstract

BACKGROUND: Dronedarone is a new antiarrhythmic drug that is being developed for the treatment of patients with atrial fibrillation.

METHODS: We conducted a multicenter trial to evaluate the use of dronedarone in 4628 patients with atrial fibrillation who had additional risk factors for death. Patients were randomly assigned to receive dronedarone, 400 mg twice a day, or placebo. The primary outcome was the first hospitalization due to cardiovascular events or death. Secondary outcomes were death from any cause, death from cardiovascular causes, and hospitalization due to cardiovascular events.

RESULTS: The mean follow-up period was 21+/-5 months, with the study drug discontinued prematurely in 696 of the 2301 patients (30.2%) receiving dronedarone and in 716 of the 2327 patients (30.8%) receiving placebo, mostly because of adverse events. The primary outcome occurred in 734 patients (31.9%) in the dronedarone group and in 917 patients (39.4%) in the placebo group, with a hazard ratio for dronedarone of 0.76 (95% confidence interval [CI], 0.69 to 0.84; P

CONCLUSIONS: Dronedarone reduced the incidence of hospitalization due to cardiovascular events or death in patients with atrial fibrillation. (ClinicalTrials.gov number, NCT00174785.)

Volume

360

Issue

7

First Page

668

Last Page

678

ISSN

1533-4406

Disciplines

Medicine and Health Sciences

PubMedID

19213680

Department(s)

Department of Medicine

Document Type

Article

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