胺碘酮或索他洛尔治疗心房颤动患者的一年治疗持续性和潜在不良事件：回顾性理赔数据库分析。

One-year treatment persistence and potential adverse events among patients with atrial fibrillation treated with amiodarone or sotalol: a retrospective claims database analysis.

机构信息

Northwestern University, Feinberg School of Medicine, 251 E. Huron Street, Chicago, IL 60611, USA.

出版信息

Clin Ther. 2011 Nov;33(11):1668-1681.e1. doi: 10.1016/j.clinthera.2011.10.005.

DOI:10.1016/j.clinthera.2011.10.005

PMID:22108302

Abstract

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.

摘要

背景

抗心律失常药物（AAD）的风险效益比影响维持窦性节律的药物治疗选择。AAD 相关的不良反应（AEs）可能会影响患者的依从性，并影响心房颤动（AF）的管理。关于临床试验环境之外 AADs 的不良反应发生率或持续用药情况的数据有限。

目的

本研究提供了美国使用最广泛的两种 AAD 之一——胺碘酮或索他洛尔治疗 AF 患者的治疗持续时间和不良反应数据。

方法

在这项回顾性队列研究中，从美国 MarketScan 理赔数据库中确定了符合以下标准的患者：（1）年龄≥18 岁，在 2004 年至 2007 年期间有口服胺碘酮或索他洛尔的药房用药记录；（2）在索引药房用药记录前<90 天，至少有 1 次住院/门诊医疗记录，诊断为 AF；（3）在索引药房用药记录前和后至少 12 个月连续参保。在活跃治疗期间，比较了治疗队列之间的预设不良反应发生率。

结果

在≥1 例胺碘酮或索他洛尔用药的 77093 例 AF 患者中，有 3459 例符合所有纳入标准（平均年龄 70.8 岁；61.6%为男性；平均 Charlson 合并症指数[CCI]为 1.58），其中 2392 例接受胺碘酮治疗（平均年龄 72.2 岁；62.5%为男性；平均 CCI 为 1.8），1067 例接受索他洛尔治疗（平均年龄 67.5 岁；59.7%为男性；平均 CCI 为 1.1）。与胺碘酮组相比，索他洛尔组的持续用药率更高（12 个月时分别为 53.2%和 30.6%；P<0.001）。与基线相比，两组患者的心血管不良事件发生率均增加。队列间比较显示，胺碘酮治疗组的心血管不良事件（594 例比 339 例/1000 患者年；P<0.001）和肺部不良事件（128 例比 61 例/1000 患者年；P<0.001）发生率更高。