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Dronedarone in high-risk permanent atrial fibrillation.

Publication ,  Journal Article
Connolly, SJ; Camm, AJ; Halperin, JL; Joyner, C; Alings, M; Amerena, J; Atar, D; Avezum, Á; Blomström, P; Borggrefe, M; Budaj, A; Chen, S-A ...
Published in: N Engl J Med
December 15, 2011

BACKGROUND: Dronedarone restores sinus rhythm and reduces hospitalization or death in intermittent atrial fibrillation. It also lowers heart rate and blood pressure and has antiadrenergic and potential ventricular antiarrhythmic effects. We hypothesized that dronedarone would reduce major vascular events in high-risk permanent atrial fibrillation. METHODS: We assigned patients who were at least 65 years of age with at least a 6-month history of permanent atrial fibrillation and risk factors for major vascular events to receive dronedarone or placebo. The first coprimary outcome was stroke, myocardial infarction, systemic embolism, or death from cardiovascular causes. The second coprimary outcome was unplanned hospitalization for a cardiovascular cause or death. RESULTS: After the enrollment of 3236 patients, the study was stopped for safety reasons. The first coprimary outcome occurred in 43 patients receiving dronedarone and 19 receiving placebo (hazard ratio, 2.29; 95% confidence interval [CI], 1.34 to 3.94; P=0.002). There were 21 deaths from cardiovascular causes in the dronedarone group and 10 in the placebo group (hazard ratio, 2.11; 95% CI, 1.00 to 4.49; P=0.046), including death from arrhythmia in 13 patients and 4 patients, respectively (hazard ratio, 3.26; 95% CI, 1.06 to 10.00; P=0.03). Stroke occurred in 23 patients in the dronedarone group and 10 in the placebo group (hazard ratio, 2.32; 95% CI, 1.11 to 4.88; P=0.02). Hospitalization for heart failure occurred in 43 patients in the dronedarone group and 24 in the placebo group (hazard ratio, 1.81; 95% CI, 1.10 to 2.99; P=0.02). CONCLUSIONS: Dronedarone increased rates of heart failure, stroke, and death from cardiovascular causes in patients with permanent atrial fibrillation who were at risk for major vascular events. Our data show that this drug should not be used in such patients. (Funded by Sanofi-Aventis; PALLAS ClinicalTrials.gov number, NCT01151137.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

December 15, 2011

Volume

365

Issue

24

Start / End Page

2268 / 2276

Location

United States

Related Subject Headings

  • Stroke
  • Risk Factors
  • Male
  • Humans
  • Hospitalization
  • Heart Rate
  • Heart Failure
  • General & Internal Medicine
  • Follow-Up Studies
  • Female
 

Citation

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Connolly, S. J., Camm, A. J., Halperin, J. L., Joyner, C., Alings, M., Amerena, J., … PALLAS Investigators, . (2011). Dronedarone in high-risk permanent atrial fibrillation. N Engl J Med, 365(24), 2268–2276. https://doi.org/10.1056/NEJMoa1109867
Connolly, Stuart J., A John Camm, Jonathan L. Halperin, Campbell Joyner, Marco Alings, John Amerena, Dan Atar, et al. “Dronedarone in high-risk permanent atrial fibrillation.N Engl J Med 365, no. 24 (December 15, 2011): 2268–76. https://doi.org/10.1056/NEJMoa1109867.
Connolly SJ, Camm AJ, Halperin JL, Joyner C, Alings M, Amerena J, et al. Dronedarone in high-risk permanent atrial fibrillation. N Engl J Med. 2011 Dec 15;365(24):2268–76.
Connolly, Stuart J., et al. “Dronedarone in high-risk permanent atrial fibrillation.N Engl J Med, vol. 365, no. 24, Dec. 2011, pp. 2268–76. Pubmed, doi:10.1056/NEJMoa1109867.
Connolly SJ, Camm AJ, Halperin JL, Joyner C, Alings M, Amerena J, Atar D, Avezum Á, Blomström P, Borggrefe M, Budaj A, Chen S-A, Ching CK, Commerford P, Dans A, Davy J-M, Delacrétaz E, Di Pasquale G, Diaz R, Dorian P, Flaker G, Golitsyn S, Gonzalez-Hermosillo A, Granger CB, Heidbüchel H, Kautzner J, Kim JS, Lanas F, Lewis BS, Merino JL, Morillo C, Murin J, Narasimhan C, Paolasso E, Parkhomenko A, Peters NS, Sim K-H, Stiles MK, Tanomsup S, Toivonen L, Tomcsányi J, Torp-Pedersen C, Tse H-F, Vardas P, Vinereanu D, Xavier D, Zhu J, Zhu J-R, Baret-Cormel L, Weinling E, Staiger C, Yusuf S, Chrolavicius S, Afzal R, Hohnloser SH, PALLAS Investigators. Dronedarone in high-risk permanent atrial fibrillation. N Engl J Med. 2011 Dec 15;365(24):2268–2276.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

December 15, 2011

Volume

365

Issue

24

Start / End Page

2268 / 2276

Location

United States

Related Subject Headings

  • Stroke
  • Risk Factors
  • Male
  • Humans
  • Hospitalization
  • Heart Rate
  • Heart Failure
  • General & Internal Medicine
  • Follow-Up Studies
  • Female