【病例学习第4期】Dronedarone（决奈达隆）

From Pharmacy Times(www.pharmacytimes.com)
Thanks to the author Craig I. Coleman, PharmD(Dr. Coleman is an assistant professor of pharmacy practice and director of the pharmacoeconomics and outcomes studies group at the University of Connecticut School of Pharmacy.)

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Dronedarone

QT, a 58-year-old African American woman, comes to the pharmacy with a new prescription. Before handing it to the pharmacist, QT explains that she was recently admitted to the hospital because she fainted due to a rapid and irregular heartbeat. She further explains that after the doctors got her heart beating normally, one of the younger ones told her to take this medication to prevent the abnormal heartbeat from happening again. The pharmacist is handed the prescription and sees that it is written for “Multaq 400 mg twice daily for atrial fibrillation #180.” Upon review of QT’s medication profile, the pharmacist discovers that the patient is also taking lisinopril 20 mg once daily, carvedilol 25 mg twice daily, spironolactone 25 mg once daily, and atorvastatin 80 mg daily. Should the pharmacist fill this prescription?

ANSWER

Multaq (dronedarone) has been demonstrated to decrease atrial fibrillation recurrence by about 25%, as well as reduce the incidence of the combined end points of hospitalization for cardiac causes and all-cause mortality in patients with higher cardiac risk. The results of the ANDROMEDA trial suggest, however, that dronedarone should not be used in patients with symptomatic heart failure, whereas these patients had a greater than 2-fold increased risk of mortality when taking dronedarone, compared with placebo. As a result of this trial, the prescribing information for dronedarone carries a black box warning stating that it “is contraindicated in patients with NYHA Class IV heart failure, or NYHA Class II-III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic.” QT’s use of lisinopril, carvedilol, and in particular, spironolactone suggests that she suffers from symptomatic heart failure. The pharmacist should not fill the prescription and should call the patient’s cardiologist to inquire about the status of her heart failure and, if appropriate, get the medication changed to another antiarrhythmic used to maintain normal sinus rhythm, such as amiodarone.


以下为翻译后的内容感谢“姚施”提供，欢迎大家对翻译结果进一步完善。


QT是一位非裔美国妇女58岁，手持（新）处方来药店取药，她在给药师处方之前，跟药师说本人最近因心跳加快以及心律不齐昏厥而住院接受治疗，经大夫的治疗心律恢复正常，其中一位年轻的医生告诉她服用一种药物可以防止心律失常的再次发生。药师拿过处方一看，只见处方上写有“Multaq 400 mg 一天两次，用于房颤180片”，药师进一步对患者的既往用药审评得知，该患者正在使用 赖诺普利20 mg，QD；卡维地洛（ carvedilol ）25 mg BID；螺内酯（ spironolactone ）25 mg QD；以及每天阿托伐他汀（ atorvastatin ）80 mg 。问药师应该调配这张处方吗？

答案

已知Multaq (决奈达隆dronedarone)可以使房颤复发下降25%，同时降低高危心脏危险患者因所有原因致死和因心脏原因而住院的联合终点的发生率。来自名为“ANDROMEDA（The Antiarrhythmic Trial with Dronedarone in Moderate to Severe Congestive Heart Failure Evaluating Morbidity Decrease）”的试验结果显示，决奈达隆不应用于有心衰的患者，这些患者使用决奈达隆增加死亡的风险是使用安慰剂组的2倍。基于这一试验结果，在决奈达隆的说明上增加了黑框警告说明“禁用于NYHA（纽约心脏病学会）心衰IV级，以及最近失代偿需住院治疗的或到心衰门诊接受治疗的NYHA II-III级”。鉴于QT目前使用赖诺普利、卡维地洛，尤其是螺内酯提示该女患者具有心衰，因此药师不应调剂这张处方，并且应与患者的心脏病大夫取得联系，确定心衰的事实，如果情况属实则应更换其他可以维持正常窦性心律的抗心律失常药，如胺碘酮。




补充内容：
决奈达隆(Multaq)简介：
　　Multaq是由sanofi-aventis发现与发展的、是过去20年在心房颤动上的主要的治疗革新之一。
　　每天服用两次Multaq 400mg 的药效与安全性为5个对照试验所评价：ATHENA, ANDROMEDA, EURIDIS, ADONIS和DAFNE。这些试验涉及将近6300个病人，其中超过3200个病人接受Multaq治疗。
　　ATHENA试验涉及了4628个AF/AFL病人，其中2300个在标准疗法的基础上的接受Multaq治疗。此试验表明，相比于服用安慰剂的病人，Multaq能减低入院和死亡数24%(P<0.001)。
　　ANDROMEDA试验是一个夭折了的试验，在收纳1000名计划中的充血性心力衰竭病人中的627名后被停止了，原因在于在决奈达隆组中，因心力衰竭恶化，导致死亡率偏高 [n=25 versus 12 (安慰剂组), p=0.027].
　　这两个试验所设计的病人总体有显著差异。在ANDROMEDA中，病人有着相对严重的心力衰竭并且已经入院，或者曾经因情况恶化而送入心衰专科门诊。这些病人主要处于NYHA II级和III级，并且在随机化情况下只有25%有过AF/AFL病史。相反，在ATHENA中，全部病人都有AF/AFL病史，71%的病人没有心力衰竭，25%的处于NYHA I 或 II，只有4%是NYHA III。
　　ANDROMEDA和ATHENA试验分别在2008年和2009年的新英国医学杂志(NEJM)中发表。

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