依折麦布与他汀类药物联合治疗对预防心梗没有优势

2011-09-21 MedSci原创 MedSci原创

  德国卫生质量和效率研究所(IQWiG)在9月12日公布了一份报告,没有证据显示在他汀类药物的基础上增加依折麦布用于预防心肌梗死患者有更多获益。   共确定2项研究用于获益评估。在这两项研究中,所有患者接受他汀类药物作为基础治疗。在为期24个月的ENHANCE研究中,一半的研究参与者分别接受依折麦布或安慰剂加他汀类治疗。在为期14个月的ARBITER-6-HALTS研究中,依折麦布与烟酸进行了

  德国卫生质量和效率研究所(IQWiG)在9月12日公布了一份报告,没有证据显示在他汀类药物的基础上增加依折麦布用于预防心肌梗死患者有更多获益。

  共确定2项研究用于获益评估。在这两项研究中,所有患者接受他汀类药物作为基础治疗。在为期24个月的ENHANCE研究中,一半的研究参与者分别接受依折麦布或安慰剂加他汀类治疗。在为期14个月的ARBITER-6-HALTS研究中,依折麦布与烟酸进行了比较。

  IQWiG分析了ENHANCE和ARBITER-6-HALTS研究关于死亡、心脑血管并发症、健康相关生活质量和不良事件的结果。

  关于患者相关的结果,这两项研究的两组患者之间均没有显示出依折麦布加他汀类药物与对照组之间的显著性差异。

  因此,IQWiG总结到,没有任何迹象表明依折麦布较烟酸或安慰剂提供了更多的获益或伤害。然而,到目前为止已有的研究规模太小或者时间太短,不能定论该药物的获益或者危害。

  医护人员的注意力目前集中在正在进行的研究上——IMPROVE-IT。这是首项以比较辛伐他汀加依折麦布与辛伐他汀加安慰剂对心血管结果的作用为主要目的研究,该项研究纳入了病情已经稳定的急性冠脉综合征高危患者,预计将在2013年得到结果。

  IQWiG在2011年5月初以初步报告的形式发表了初步的结果,并邀请有兴趣的患者发表评论。当评论阶段结束时,对初步结果进行了校正并将以最终的报告形式发送给了合约单位——联邦联合委员会。2011年7月,只接收到1份书写的评论,以单独的文件作为最后报告同时公布。这一报告与外部专家合作完成。


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