探討Dronedarone用於心房顫動治療的療效、安全性與上市後使用情形

Efficacy, Safety, and Post-Marketing Utilization of Dronedarone in Patients With Atrial Fibrillation

蘇靖晏(Ching-Yen Su) ； 沈麗娟(Li-Jiuan Shen) ； 劉玲妤(Ling-Yu Liu)

《臺灣臨床藥學雜誌》 26卷3期 (2018/07) Pp. 173-181

https://doi.org/10.6168/FJCP.201807_26(3).0001

摘要

罹患心房顫動(atrial fibrillation, AF)的病人常因伴隨的各種症狀嚴重影響生活品質，心律控制的治療策略被認為能夠減少症狀及維持竇性心律，治療指引中建議可考慮使用的抗心律不整藥品包含flecainide、propafenone、amiodarone、dronedarone和sotalol，其中2009年在美國和歐洲核准上市的dronedarone為相對較新的心律控制藥品。在臨床試驗中dronedarone預防AF復發的效果不如amiodarone，但是卻能夠減少AF病人的住院率，並且有較佳的安全性和病人服藥順從性，因此整體來說dronedarone相較於amiodarone有降低AF病人死亡率的趨勢；同時在觀察性研究中也證實dronedarone降低AF病人住院率的效果，無論是作為一線或二線心律控制藥品。然而，dronedarone於真實世界的臨床使用情形卻不如預期，且在不同國家中也有很大的差異，可能的原因包含安全性考量、禁忌症、臨床使用經驗、價格和各國保險給付規範等，但造成此現象的原因仍需更進一步研究方能窺知。本文將討論不同特性和共病症之AF病人的藥物治療，以及dronedarone用於AF治療的療效、安全性與上市後使用情形。

關鍵字

心房顫動 ； 心律控制 ； Dronedarone ； 藥品使用

並列摘要

Patients with atrial fibrillation (AF) suffer from poor quality of life due to various concomitant symptoms. The rhythm-control treatment approach is considered effective in alleviating symptoms and maintaining sinus rhythm. Antiarrhythmic drugs, including flecainide, propafenone, amiodarone, dronedarone, and sotalol, are recommended in the treatment guidelines. Among them, dronedarone approved in the United States and Europe in 2009 is a relatively new drug for rhythm control. Although dronedarone was shown to be less effective than amiodarone in preventing AF recurrence in the clinical trial, dronedarone reduced the incidence of hospitalization with better safety profiles and patient compliance. Therefore, overall, dronedarone showed a trend toward reduced all-cause mortality in comparison with amiodarone. Meanwhile, the reduction in hospital admissions with dronedarone, either as a first-line or second-line rhythm-control therapy, was also demonstrated in the observational study. However, the clinical use of dronedarone in real-world practice was not as expected and also varied across countries. The probable reasons may include safety concerns, contraindications, physician experience, price, and reimbursement restrictions, but the unraveling of the underlying causes warrants further investigation. The strategies of pharmacological treatments for AF patients with different characteristics or comorbidities, as well as the efficacy, safety, and post-marketing utilization of dronedarone in AF treatment will be discussed in the present review.

並列關鍵字

Atrial Fibrillation ； Rhythm Control ； Dronedarone ； Drug Utilization