TY - JOUR
T1 - One-year treatment persistence and potential adverse events among patients with atrial fibrillation treated with amiodarone or sotalol
T2 - A retrospective claims database analysis
AU - Kim, Michael H.
AU - Smith, Paula J.
AU - Jhaveri, Mehul
AU - Lin, Jay
AU - Klingman, David
N1 - Funding Information:
The study was funded by sanofi-aventis US, which provided support with the design and conduct of the study and editorial support for the development of this manuscript. Statistical analyses were performed by Drs. Smith and Klingman of IMS Health Inc. All authors contributed to discussions of the data analysis plan, interpretation of the results, and drafting the article for publication. Dr. Kim is a research consultant to sanofi-aventis, has served on advisory boards for sanofi-aventis, and is a member of the sanofi-aventis speakers' bureau. Dr. Jhaveri is an employee of sanofi-aventis. Dr. Lin is an employee of Novosys Health, which has a research consulting agreement with sanofi-aventis. Dr. Smith is an employee of IMS Health Inc., which has a research consulting agreement with sanofi-aventis. At the time of the study, Dr. Klingman was an employee of IMS Health Inc. The authors have indicated that they have no other conflicts of interest regarding the content of this article.
Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.
PY - 2011/11
Y1 - 2011/11
N2 - Background: The risk-benefit profile of antiarrhythmic drugs (AADs) affects the choice of pharmacotherapy for maintenance of sinus rhythm. Adverse events (AEs) associated with AADs may influence patient compliance and compromise the management of atrial fibrillation (AF). There are limited data on the incidence of AEs or persistence with AADs outside the clinical trial environment. Objective: This study provides treatment persistence and AE data for patients with AF receiving treatment with amiodarone or sotalol, 2 of the most widely used AADs in the United States. Methods: In this retrospective cohort study, patients satisfying the following criteria were identified from the US MarketScan claims databases: (1) age ≥18 years with a pharmacy claim for oral amiodarone or sotalol between 2004 and 2007; (2) ≥1 inpatient/outpatient medical claim with an AF diagnosis <90 days before the earliest (index) pharmacy claim; and (3) ≥12 months' continuous enrollment before and after the index pharmacy claim. Prespecified AE rates were compared between treatment cohorts during active treatment. Results: Among 77,093 AF patients with ≥1 claim for amiodarone or sotalol, 3459 met all inclusion criteria (mean age, 70.8 years; 61.6% male; mean Charlson Comorbidity Index [CCI], 1.58), of whom 2392 received amiodarone (mean age, 72.2 years; 62.5% male; mean CCI, 1.8) and 1067 received sotalol (mean age, 67.5 years; 59.7% male; mean CCI, 1.1). Persistence was higher among the sotalol cohort than the amiodarone cohort (53.2% vs 30.6% at 12 months; P < 0.001). Postindex versus preindex comparisons revealed increases in cardiovascular AE rates in both cohorts. Intercohort comparisons showed higher rates of cardiovascular AEs (594 vs 339 patients/1000 patient-years; P < 0.001) and pulmonary AEs (128 vs 61 patients/1000 patient-years; P < 0.001) during active amiodarone treatment. Conclusions: Among the population analyzed, patients with AF receiving amiodarone versus sotalol therapy had differing clinical characteristics. Patients experienced frequent AEs (particularly cardiovascular events) with amiodarone and sotalol, and many discontinued treatment during the first year.
AB - Background: The risk-benefit profile of antiarrhythmic drugs (AADs) affects the choice of pharmacotherapy for maintenance of sinus rhythm. Adverse events (AEs) associated with AADs may influence patient compliance and compromise the management of atrial fibrillation (AF). There are limited data on the incidence of AEs or persistence with AADs outside the clinical trial environment. Objective: This study provides treatment persistence and AE data for patients with AF receiving treatment with amiodarone or sotalol, 2 of the most widely used AADs in the United States. Methods: In this retrospective cohort study, patients satisfying the following criteria were identified from the US MarketScan claims databases: (1) age ≥18 years with a pharmacy claim for oral amiodarone or sotalol between 2004 and 2007; (2) ≥1 inpatient/outpatient medical claim with an AF diagnosis <90 days before the earliest (index) pharmacy claim; and (3) ≥12 months' continuous enrollment before and after the index pharmacy claim. Prespecified AE rates were compared between treatment cohorts during active treatment. Results: Among 77,093 AF patients with ≥1 claim for amiodarone or sotalol, 3459 met all inclusion criteria (mean age, 70.8 years; 61.6% male; mean Charlson Comorbidity Index [CCI], 1.58), of whom 2392 received amiodarone (mean age, 72.2 years; 62.5% male; mean CCI, 1.8) and 1067 received sotalol (mean age, 67.5 years; 59.7% male; mean CCI, 1.1). Persistence was higher among the sotalol cohort than the amiodarone cohort (53.2% vs 30.6% at 12 months; P < 0.001). Postindex versus preindex comparisons revealed increases in cardiovascular AE rates in both cohorts. Intercohort comparisons showed higher rates of cardiovascular AEs (594 vs 339 patients/1000 patient-years; P < 0.001) and pulmonary AEs (128 vs 61 patients/1000 patient-years; P < 0.001) during active amiodarone treatment. Conclusions: Among the population analyzed, patients with AF receiving amiodarone versus sotalol therapy had differing clinical characteristics. Patients experienced frequent AEs (particularly cardiovascular events) with amiodarone and sotalol, and many discontinued treatment during the first year.
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U2 - 10.1016/j.clinthera.2011.10.005
DO - 10.1016/j.clinthera.2011.10.005
M3 - Article
C2 - 22108302
AN - SCOPUS:82855166070
VL - 33
SP - 1668-1681.e1
JO - Clinical Therapeutics
JF - Clinical Therapeutics
SN - 0149-2918
IS - 11
ER -