EMA正就抗心律失常药Multaq (决奈达隆）的心血管风险进行评估

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http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/07/news_detail_001301.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1

11/07/2011

European Medicines Agency reviews cardiovascular risk of Multaq
Ongoing benefit-risk assessment broadened
The European Medicines Agency is reviewing the cardiovascular risk of the anti-arrhythmic medicine Multaq (dronedarone), from Sanofi Aventis. This follows the company’s announcement on 7 July 2011 of its discontinuation of the PALLAS study, because of the occurrence of severe cardiovascular events in some patients taking Multaq.
In the PALLAS study Multaq was being investigated in patients over 65 years of age with permanent atrial fibrillation. The patient population being studied in the PALLAS study is different from the population for which Multaq is currently approved, which is patients who currently have or have had non-permanent atrial fibrillation. The study was carried out as part of the ongoing development programme for Multaq. At the time the study was stopped 3,149 patients were enrolled.
The study was looking at the rate of major cardiovascular events (stroke or myocardial infarction) or hospitalisations due to cardiovascular events, or death. It found a higher rate of events and hospitalisations with Multaq when compared with placebo.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) started a review in January 2011 of the overall benefit-risk balance of Multaq following reports of severe liver injury. The scope of this review has now been extended to also assess new information from the PALLAS study and the CHMP will determine the need for any further action at its next meeting of 18-21 July 2011.
Notes

• Multaq has been authorised in the European Union since November 2009.
• The review of Multaq is being conducted in the context of a formal review under Article 20 of Regulation (EC) No 726/2004, initiated by the European Commission on 21 January 2011.
• On 8 July 2011 the European Commission asked the Agency to broaden this review to include also data from the PALLAS study

覃药帅

欧洲药品局审查心血管风险multaq
持续的利益风险评估扩大
欧洲药品管理局正在审查心血管危险的抗心律失常药multaq（决奈达隆），由赛诺菲安万特公司。在此之前，该公司宣布在七月7日2011停止帕拉斯的研究，因为严重心血管事件的发生在一些病人服用multaq。
在帕拉斯的研究multaq正在调查65岁以上患者永久性心房颤动。病人的人口正在研究在雅典娜的研究是从不同的人口为multaq目前批准，这是谁患者目前或有永久性心房颤动。这项研究的一部分进行的持续发展方案multaq。在时间停止研究3149例。
本研究率看，主要心血管事件（中风或心肌梗死）或住院治疗，由于心血管事件，或死亡。它找到了一个较高的事件和住院与multaq时与安慰剂相比。
该机构的委员会的医药产品供人类使用（公司）开始在一月审查2011的整体利益风险平衡的multaq下列严重肝损伤的报告。本次审查的范围现在已经扩大到也评估新的信息从帕拉斯的研究和公司将决定是否需要任何进一步的行动在其下一次会议，七月18 - 21日2011。
注释
multaq已获准在欧洲联盟自十一月2009.the审查multaq正在进行的一个正式的审查20条条例（欧共体）726 /2004，由欧盟委员会在一月212011.on82011七月欧盟委员会要求该机构扩大这一审查也包括数据帕拉斯的研究