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Journal of the American College of Cardiology

Clinical Articles, News & Views

Safety of dronedarone in routine clinical care

Dronedarone, as prescribed to atrial fibrillation (AF) patients in Sweden, has not exposed patients to increased risks of death or liver disease, according to a study published recently in the Journal of the American College of Cardiology.1

The authors identified 174,995 patients with a diagnosis of AF during 2010–2012 from the Swedish Patient Register. Of these, 4,856 patients had received dronedarone according to the Swedish Drug Register and 170,139 patients who had not were used as control population. Mean follow up was 1.6 years, minimum follow up was 6 months.

Patients prescribed dronedarone were younger (65.5 vs. 75.7 years, p<0.0001) and healthier than control patients. The annual mortality among dronedarone patients was 1.3% compared to 14.0% in the control population.

There were no sudden cardiac deaths, and no deaths related to liver failure among patients on dronedarone treatment. After propensity score matching and adjustment for cofactors, dronedarone patients had lower mortality than other AF patients (HR 0.41, CI 0.33-0.51). Dronedarone patients with heart failure had lower mortality than other heart failure patients (HR 0.40, CI 0.30-0.53). They also had lower mortality than expected from the general population (Standardised Mortality Ratio 0.67, CI 0.55-0.78) indicating selection of low risk patients. The risk of liver disease was not increased (HR 0.57, CI 0.34-0.92).

References

1. Friberg L. Safety of dronedarone in routine clinical care. J Am Coll Cardiol 2014. http://dx.doi.org/10.1016/j.jacc.2014.02.601

Published on: April 30, 2014

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ENDORSED BY

  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association
 

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