PharmaLex US Corp, Fairfax, Virginia, USA.
HealthCore, Andover, Massachusetts, USA.
Pharmacoepidemiol Drug Saf. 2021 Oct;30(10):1353-1359. doi: 10.1002/pds.5233. Epub 2021 May 4.
To compare risks of interstitial lung disease (ILD) between patients treated with dronedarone versus other antiarrhythmics.
Parallel retrospective cohort studies were conducted in the United States Department of Defense Military Health System database (DoD) and the HealthCore Integrated Research Database (HIRD). Study patients were treated for atrial fibrillation (AF) with dronedarone, amiodarone, sotalol, or flecainide. Propensity score matching was employed to create analysis cohorts balanced on baseline variables considered potential confounders of treatment decisions. The study period of July 20, 2008 through September 30, 2014 included a 1-year baseline and minimum 6 months of follow-up, for patients with drugs dispensed between July 20, 2009 and March 31, 2014. Suspect ILD outcomes were reviewed by independent adjudicators. Cox proportional hazards regression compared risk of confirmed ILD between dronedarone and each comparator cohort. A sensitivity analysis examined the effect of broadening the outcome definition.
A total 72 ILD cases (52 DoD; 20 HIRD) were confirmed among 27 892 patients. ILD risk was significantly higher among amiodarone than dronedarone initiators in DoD (HR = 2.5; 95% CI = 1.1-5.3, p = 0.02). No difference was detected in HIRD (HR = 1.0; 95% CI = 0.4-2.4). Corresponding risks in sotalol and flecainide exposure groups did not differ significantly from dronedarone in either database.
ILD risk among AF patients initiated on dronedarone therapy was comparable to or lower than that of amiodarone initiators, and similar to that of new sotalol or flecainide users. This finding suggests that elevated ILD risk associated with amiodarone does not necessarily extend to dronedarone or other antiarrhythmic drugs.
比较使用决奈达隆与其他抗心律失常药物治疗的患者发生间质性肺病（ILD）的风险。
在美国国防部医疗保健系统数据库（DoD）和 HealthCore 综合研究数据库（HIRD）中进行了平行的回顾性队列研究。研究患者因心房颤动（AF）接受决奈达隆、胺碘酮、索他洛尔或氟卡尼治疗。采用倾向评分匹配创建分析队列，使基线变量平衡，这些变量被认为是治疗决策的潜在混杂因素。研究期间为 2008 年 7 月 20 日至 2014 年 9 月 30 日，包括 1 年的基线期和至少 6 个月的随访期，适用于 2009 年 7 月 20 日至 2014 年 3 月 31 日期间配药的患者。由独立裁决者审查疑似 ILD 结果。Cox 比例风险回归比较了决奈达隆与每个对照队列确诊 ILD 的风险。敏感性分析检查了拓宽结局定义的效果。
在 27892 例患者中，共确认了 72 例 ILD 病例（52 例来自 DoD；20 例来自 HIRD）。在 DoD 中，与决奈达隆相比，胺碘酮起始治疗者的 ILD 风险显著更高（HR=2.5；95%CI=1.1-5.3，p=0.02）。在 HIRD 中未发现差异（HR=1.0；95%CI=0.4-2.4）。在这两个数据库中，索他洛尔和氟卡尼暴露组的相应风险与决奈达隆相比均无显著差异。
接受决奈达隆治疗的 AF 患者的 ILD 风险与胺碘酮起始治疗者相当或更低，与新的索他洛尔或氟卡尼使用者相似。这一发现表明，与胺碘酮相关的 ILD 风险升高不一定会扩展至决奈达隆或其他抗心律失常药物。
