Key result
Dronedarone maintains sinus rhythm in only ~30% of patients, with nearly half discontinuing therapy.
Why the study?
The efficacy and tolerability of dronedarone in clinical practice for patients with atrial fibrillation were investigated due to limited real-world data.
Observational (n=208)
No
Dronedarone shows limited real-world effectiveness; leaves open the need for comparative trials in AF rhythm control.
BACKGROUND: Dronedarone is a new antiarrhythmic drug used in the treatment of atrial fibrillation (AF). We investigate its efficacy and tolerability in clinical practice. METHODS: We identified 208 patients treated with dronedarone for AF at the Northwestern outpatient practice. Charts were reviewed for clinical efficacy and reasons for discontinuation of the drug. RESULTS: The average age was 65.2 ± 10.8 years, 37% females. Paroxysmal, persistent andpermanent AF were noted in 46.2%, 51.9%, and 1.9%, respectively. Average ejection fraction was 56.3 ± 9.1%, 12.8% had a history of congestive heart failure, and 10.3% had valvularheart disease. Dronedarone was discontinued in 25 patients after curative catheter or surgical ablation procedure. Of the remaining 183 patients, dronedarone was discontinued in 48.6% after a mean duration of 6.2 ± 6.3 months because of in efficacy (26.2%), side effects (6%), and other reasons (16.4%). For those remaining on dronedarone (n = 94), after a mean of 11.6 ± 6.6 months, clinical efficacy (resolution of or patient-reported improvement in symptoms) was noted in 45.4% patients. On dronedarone therapy, 57.4% had no AF on follow-up (overallefficacy of 29.5%). To evaluate efficacy, ECG only or long-term monitoring were performed in 62.7% and 37.3%, respectively, and found no AF in 69.2 and 48.4%, respectively. There were 3 deaths and 2 transient ischemic attacks (TIA) off dronedarone vs. 1 death, 1 TIA and 2 strokes on dronedarone. CONCLUSIONS: Dronedarone has a significant discontinuation rate due to both inefficacy and side effects in clinical practice. Nevertheless, it has moderate clinical efficacy and tolerability in an outpatient population of patients with AF.
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Teme et al. (2013) conducted an observational in Atrial fibrillation (n=208). Dronedarone was evaluated on Overall efficacy (no atrial fibrillation documented on follow-up). In clinical practice, dronedarone demonstrated an overall efficacy of 29.5% for maintaining sinus rhythm, but was associated with a 48.6% discontinuation rate primarily due to inefficacy and side effects.
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