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Effect of Dronedarone on Cardiovascular Events in Atrial Fibrillation

2011; Massachusetts Medical Society; Volume: 364; Issue: 15 Linguagem: Inglês

10.1056/nejmx110028

1533-4406

Cardiac Arrhythmias and Treatments

Background: Dronedarorie is a new antiarrhythniie drug that is being developed (or the treatment of patients with alnal iihrillalion. Methods: We conducted a multiceuter trial to evaluate the use of dronedarone in 4628 patienls with atrial fibrillation who had additional risk factors for death. Patients wen.' randomly assigned lo receive dronedarone, 400 mg twice a day, or placebo. The primary outcome was the first hospitalization due to cardiovascular e\ents or death. Secondary outcomes were death from any cause, death from cardiovascular causes, and hospilahzalion 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 9i7 patients (39.4%) in the placebo group, with a hazard ratio for dronedarone ol 0.76 (95% confidence interval [CIJ. 0.69 to 0.84; P<0.001). There were 1 16 deaths (5.0%) in the dronedarone group and 139 (6.0%) in the placebo group (hazard ratio, 0.84; 95% Cl. 0.66 to 1 .08: P = 0.18). There were 63 deaths from cardiovascular causes (2.7%) in the dronedarone group and 90 (3.9%) in ihe placebo group (hazard ratio. 0.71; 95% CI. 0.51 to 0.98; P = 0.03). largely due to a reduction in (he rale of death from arrhythmia with dronedarone. The dronedarone group had higher rates of bradycardia, QT-interval prolongation, nausea, diarrhea, rash, and an increased serum creatinine level than the placebo group. Hales of ihyroid- and pulmonary-related adverse events were nol significantly different between the two groups. (Conclusion: Dronedarone reduced the incidence of. hospitalization due to cardiovascular events or death in patients with atrial fibrillation. (ChnicalTrials.gov number. NCTOO 174785.).