Northwestern University, Chicago, IL 60611, USA.
Curr Med Res Opin. 2009 Dec;25(12):3037-47. doi: 10.1185/03007990903368716.
Rhythm- and rate-control therapies are an essential part of atrial fibrillation (AF) management; however, the use of existing agents is often limited by the occurrence of adverse events. The aim of this study was to evaluate suspected adverse events and adverse event monitoring, and associated medical costs, in patients receiving AF rhythm-control and/or rate-control therapy.
This retrospective cohort study used claims data from the Integrated Healthcare Information Systems National Managed Care Benchmark Database from 2002-2006. Patients hospitalized for AF (primary diagnosis), and who had at least 365 days' enrollment before and after the initial (index) AF hospitalization, were included in the analysis. Suspected AF therapy-related adverse events and function tests for adverse event monitoring were identified according to pre-specified diagnosis codes/procedures, and examined over the 12 months following discharge from the index hospitalization. Events/function tests had to have occurred within 90 days of a claim for AF therapy to be considered a suspected adverse event/adverse event monitoring.
Of 4174 AF patients meeting the study criteria, 3323 received AF drugs; 428 received rhythm-control only (12.9%), 2130 rate-control only (64.1%), and 765 combined rhythm/rate-control therapy (23.0%). Overall, 50.1% of treated patients had a suspected adverse event and/or function test for adverse event monitoring (45.5% with rate-control, 53.5% with rhythm-control, and 61.2% with combined rhythm/rate-control). Suspected cardiovascular adverse events were the most common events (occurring in 36.1% of patients), followed by pulmonary (6.1%), and endocrine events (5.9%). Overall, suspected adverse events/function tests were associated with mean annual per-patient costs of $3089 ($1750 with rhythm-control, $2041 with rate control, and $6755 with combined rhythm/rate-control).
As a retrospective analysis, the study is subject to potential selection bias, while its reliance on diagnostic codes for identification of AF and suspected adverse events is a source of potential investigator error. A direct cause-effect relationship between suspected adverse events/function tests and AF therapy cannot be confirmed based on the claims data available.
The incidence of suspected adverse events and adverse event monitoring during AF rhythm-control and/or rate-control therapy is high. Costs associated with adverse events and adverse event monitoring are likely to add considerably to the overall burden of AF management.
节律控制和心率控制疗法是心房颤动（AF）管理的重要组成部分；然而，现有药物的使用通常受到不良反应发生的限制。本研究旨在评估接受 AF 节律控制和/或心率控制治疗的患者发生疑似不良事件和不良事件监测的情况，并评估相关医疗费用。
本回顾性队列研究使用了 2002 年至 2006 年来自集成医疗信息系统国家管理式医疗基准数据库的索赔数据。纳入分析的患者为因 AF（主要诊断）住院，并在首次（索引）AF 住院前后至少有 365 天的入组。根据预先规定的诊断代码/程序，确定疑似与 AF 治疗相关的不良事件和用于不良事件监测的功能检测，并在索引住院后 12 个月内进行检查。事件/功能检测必须在 AF 治疗索赔后 90 天内发生，才能被视为疑似不良事件/不良事件监测。
符合研究标准的 4174 例 AF 患者中，有 3323 例接受了 AF 药物治疗；428 例仅接受节律控制（12.9%），2130 例仅接受心率控制（64.1%），765 例联合节律/心率控制治疗（23.0%）。总体而言，50.1%的治疗患者发生了疑似不良事件和/或用于不良事件监测的功能检测（接受心率控制的患者中为 45.5%，接受节律控制的患者中为 53.5%，接受联合节律/心率控制的患者中为 61.2%）。疑似心血管不良事件是最常见的事件（发生在 36.1%的患者中），其次是肺部（6.1%）和内分泌事件（5.9%）。总体而言，疑似不良事件/功能检测与每位患者的年平均费用相关，为 3089 美元（节律控制为 1750 美元，心率控制为 2041 美元，联合节律/心率控制为 6755 美元）。
由于这是一项回顾性分析，因此该研究可能存在潜在的选择偏倚，同时，其依赖诊断代码来识别 AF 和疑似不良事件也是潜在的调查员错误来源。基于可用的索赔数据，不能确定疑似不良事件/功能检测与 AF 治疗之间存在直接的因果关系。
在接受 AF 节律控制和/或心率控制治疗期间，疑似不良事件和不良事件监测的发生率很高。与不良事件和不良事件监测相关的成本很可能会大大增加 AF 管理的整体负担。
