Journal of the American Heart Association · 2025
Clinical and Economic Outcomes of Dronedarone Versus Amiodarone Among Patients With Atrial Fibrillation.
СтатьяНаблюдательное исследованиеСравнительное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Steinberg Benjamin A, Dabbous Firas, Preblick Ron, Shridharmurthy Divya, McKindley David S, Rashkin Jason, Huse Samuel, Colby Chris, Singh Jagmeet P
Аннотация
BACKGROUND: This retrospective observational study compared adverse events (AEs) and health care resource use among patients with atrial fibrillation treated with dronedarone versus amiodarone.
METHODS: Adults with atrial fibrillation who initiated dronedarone or amiodarone between January 1, 2010 and September 30, 2021 were propensity score matched in Optum's deidentified Clinformatics Data Mart Database. Outcomes included AEs (described in the dronedarone/amiodarone Food and Drug Administration labels and reported in the Food and Drug Administration AE Reporting System) and all-cause and cardiovascular-related health care resource use. Generalized linear models with Poisson distribution were used to compare the risk of AEs between the 2 cohorts. After matching, 12 210 dronedarone-treated patients were paired 1:1 with amiodarone-treated patients. For each AE, patients who experienced the AE during baseline were excluded.
RESULTS: During follow-up, lower event rates of AEs were observed with dronedarone versus amiodarone; the rate ratio for any cardiac and vascular AE was 0.71 (95% CI, 0.69-0.72), any respiratory AE was 0.65 (95% CI, 0.63-0.66), and any gastrointestinal/hepatobiliary AE was 0.81 (95% CI, 0.79-0.84). Compared with amiodarone-treated patients, dronedarone-treated patients experienced lower event rates of all-cause hospitalization (0.69 [95% CI, 0.67-0.71]) and all-cause outpatient visits (0.87 [95% CI, 0.87-0.87]). Although the incidence of cardiovascular-related hospitalization was higher with dronedarone versus amiodarone, event rates were not statistically different. Cardiovascular-related outpatient visits were significantly reduced with dronedarone versus amiodarone with an event rate of 0.95 (95% CI, 0.94-0.96).
CONCLUSIONS: In this study, lower event/incidence rates of AEs and health care resource use were observed in patients with atrial fibrillation treated with dronedarone versus amiodarone.
METHODS: Adults with atrial fibrillation who initiated dronedarone or amiodarone between January 1, 2010 and September 30, 2021 were propensity score matched in Optum's deidentified Clinformatics Data Mart Database. Outcomes included AEs (described in the dronedarone/amiodarone Food and Drug Administration labels and reported in the Food and Drug Administration AE Reporting System) and all-cause and cardiovascular-related health care resource use. Generalized linear models with Poisson distribution were used to compare the risk of AEs between the 2 cohorts. After matching, 12 210 dronedarone-treated patients were paired 1:1 with amiodarone-treated patients. For each AE, patients who experienced the AE during baseline were excluded.
RESULTS: During follow-up, lower event rates of AEs were observed with dronedarone versus amiodarone; the rate ratio for any cardiac and vascular AE was 0.71 (95% CI, 0.69-0.72), any respiratory AE was 0.65 (95% CI, 0.63-0.66), and any gastrointestinal/hepatobiliary AE was 0.81 (95% CI, 0.79-0.84). Compared with amiodarone-treated patients, dronedarone-treated patients experienced lower event rates of all-cause hospitalization (0.69 [95% CI, 0.67-0.71]) and all-cause outpatient visits (0.87 [95% CI, 0.87-0.87]). Although the incidence of cardiovascular-related hospitalization was higher with dronedarone versus amiodarone, event rates were not statistically different. Cardiovascular-related outpatient visits were significantly reduced with dronedarone versus amiodarone with an event rate of 0.95 (95% CI, 0.94-0.96).
CONCLUSIONS: In this study, lower event/incidence rates of AEs and health care resource use were observed in patients with atrial fibrillation treated with dronedarone versus amiodarone.