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Gao S, Dai W, Zhang L, et al. Risk of Cardiovascular Events, Stroke, Congestive Heart Failure, Interstitial Lung Disease, and Acute Liver Injury: Dronedarone versus Amiodarone and Other Antiarrhythmics. J Atr Fibrillation. 2013;6(4):890doi: 10.4022/jafib.890.
Gao, S., Dai, W., Zhang, L., Juhaeri, J., Wang, Y., & Caubel, P. (2013). Risk of Cardiovascular Events, Stroke, Congestive Heart Failure, Interstitial Lung Disease, and Acute Liver Injury: Dronedarone versus Amiodarone and Other Antiarrhythmics. Journal of atrial fibrillation, 6(4), 890. https://doi.org/10.4022/jafib.890
Gao, Shujun, et al. "Risk of Cardiovascular Events, Stroke, Congestive Heart Failure, Interstitial Lung Disease, and Acute Liver Injury: Dronedarone versus Amiodarone and Other Antiarrhythmics." Journal of atrial fibrillation vol. 6,4 (2013): 890. doi: https://doi.org/10.4022/jafib.890
Gao S, Dai W, Zhang L, Juhaeri J, Wang Y, Caubel P. Risk of Cardiovascular Events, Stroke, Congestive Heart Failure, Interstitial Lung Disease, and Acute Liver Injury: Dronedarone versus Amiodarone and Other Antiarrhythmics. J Atr Fibrillation. 2013 Dec 31;6(4):890. doi: 10.4022/jafib.890. eCollection 2013 Dec. PMID: 28496906; PMCID: PMC5153130.
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J Atr Fibrillation. 2013 Dec 31;6(4):890. doi: 10.4022/jafib.890. eCollection 2013 Dec.

Risk of Cardiovascular Events, Stroke, Congestive Heart Failure, Interstitial Lung Disease, and Acute Liver Injury: Dronedarone versus Amiodarone and Other Antiarrhythmics.

Journal of atrial fibrillation

Shujun Gao, Wanju Dai, Ling Zhang, Juhaeri Juhaeri, Yunxun Wang, Patrick Caubel

Affiliations

  1. Clinical Safety and Pharmacovigilance, Daiichi Sankyo, Edison, NJ 08837, USA.
  2. Global Pharmacovigilance and Epidemiology, Sanofi, Bridgewater, 08807, USA.

PMID: 28496906 PMCID: PMC5153130 DOI: 10.4022/jafib.890

Abstract

No published studies have evaluated the risks of cardiovascular (CV) events, stroke, congestive heart failure (CHF), interstitial lung disease (ILD), and severe acute liver injury (ALI) related to antiarrhythmics treatment in real-world clinical practice setting. We examined the relationship between the above events and the selected antiarrhythmics in the real-world setting in the US. Using a retrospective cohort design, the hazard ratios of the outcome events were analyzed from 10,455 adult patients with a diagnosis of atrial fibrillation/atrial flutter and a new treatment with dronedarone (comparison drug), amiodarone, sotalol, flecainide, or propafenone between 07/20/2009 and 12/31/2010 from the Clinformatics Data MartTM database. The patients were followed until: 1) switch to another antiarrhythmic drug, 2) occurrence of the outcome event, 3) end of enrollment, or 4) end of the study period, whichever occurred first. No significant differences were observed in the hazard ratios of the outcome events between dronedarone, amiodarone, and the other antiarrhythmics, except that amiodarone was associated with a higher risk of CV events (adjusted HR = 1.7, 95%CI: 1.1-2.4) and stroke (adjusted HR = 2.0, 95%CI: 1.33.2), compared to dronedarone, especially amongst patients without a CHF history (adjusted HR = 2.4, 95%CI: 1.4-3.8 and 2.2, 95%CI: 1.23.9). A higher risk of CHF was also associated with amiodarone in patients without history of CHF at baseline (adjusted HR = 2.7, 95%CI: 2.03.6). In this real-world investigation, no difference in risk was observed between dronedarone, sotalol, and propafenone initiators for CV events, stroke, CHF, ILD, and ALI. Amiodarone was associated with higher risks of CV events, stroke, and CHF than dronedarone in patients without a CHF history, indicating dronedarone could be an alternative therapy option with lower risk of CV events than amiodarone for the above patients.

Keywords: Claims; Cohort Study; Database; Dronedarone; Relative Risk

References

  1. Pharmacoepidemiol Drug Saf. 2011 Jul;20(7):700-8 - PubMed
  2. Am J Epidemiol. 2003 Nov 1;158(9):915-20 - PubMed
  3. Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:256-60 - PubMed
  4. Pharmacoepidemiol Drug Saf. 2005 Jul;14(7):465-76 - PubMed
  5. N Engl J Med. 1995 Jul 13;333(2):77-82 - PubMed
  6. Br J Clin Pharmacol. 2008 Jul;66(1):82-7 - PubMed
  7. N Engl J Med. 2008 Jun 19;358(25):2678-87 - PubMed
  8. Consult Pharm. 2010 Sep;25(9):555-69 - PubMed
  9. Med Care. 2005 Nov;43(11):1130-9 - PubMed
  10. N Engl J Med. 2009 Feb 12;360(7):668-78 - PubMed
  11. BMC Health Serv Res. 2007 Oct 02;7:159 - PubMed
  12. Circ J. 2007 Oct;71(10):1610-6 - PubMed
  13. N Engl J Med. 2007 Sep 6;357(10):987-99 - PubMed
  14. Med Care. 2005 May;43(5):480-5 - PubMed
  15. N Engl J Med. 2011 Dec 15;365(24):2268-76 - PubMed
  16. Circulation. 1990 Jul;82(1):51-9 - PubMed
  17. J Am Coll Cardiol. 1988 Sep;12(3):781-8 - PubMed
  18. Drug Saf. 2010 Jul 1;33(7):539-58 - PubMed

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