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Published on: February 28, 2012
Increased mortality after dronedarone therapy for severe heart failure
Lars Køber1, Christian Torp-Pedersen, John J V McMurray
1Department of Cardiology, Rigshospitalet, University of Copenhagen, Denmark. lk@heart.dk
The New England Journal of Medicine
|June 21, 2008
Summary
Dronedarone showed increased early mortality in severe heart failure patients, primarily due to worsening heart failure. This antiarrhythmic drug was halted early for safety concerns in this population.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Dronedarone, an iodine-free antiarrhythmic, was investigated for heart failure treatment.
- Its properties resemble amiodarone but without iodine-related side effects.
Purpose of the Study:
- To evaluate the efficacy and safety of dronedarone in patients with symptomatic heart failure.
- To assess the composite endpoint of all-cause death or heart failure hospitalization.
Main Methods:
- A double-blind, multicenter trial planned to enroll 1000 patients with severe left ventricular systolic dysfunction.
- Patients received either dronedarone (400 mg twice daily) or placebo.
Main Results:
- The trial was terminated early due to safety concerns after enrolling 627 patients.
- Dronedarone group showed increased all-cause mortality (8.1% vs 3.8%), mainly from worsening heart failure.
- No significant difference in the primary endpoint between groups; increased creatinine events noted with dronedarone.
Conclusions:
- Dronedarone treatment was linked to higher early mortality in severe heart failure patients.
- The excess deaths were predominantly due to heart failure exacerbation.
- The drug's use in this patient group requires careful consideration due to safety findings.
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