双联抗血小板药物多立维®在华上市,进一步提升ACS患者用药依从性

2022-05-22 赛诺菲中国 赛诺菲中国

ACS是由急性心肌缺血引起的一组临床综合征,主要由于冠状动脉不稳定斑块破裂或糜烂导致完全或不完全闭塞性血栓而形成。

2022522日,赛诺菲中国宣布旗下心血管领域创新药物多立维®氯吡格雷阿司匹林片(以下简称多立维)正式在中国上市,用于预防急性冠状动脉综合征(ACS)成年患者的动脉粥样硬化血栓形成事件。

ACS是由急性心肌缺血引起的一组临床综合征,主要由于冠状动脉不稳定斑块破裂或糜烂导致完全或不完全闭塞性血栓而形成。其中包括ST段抬高型心肌梗死(STEMI)、非ST段抬高型心肌梗死(NSTEMI)和不稳定性心绞痛(UA),前两者统称急性心肌梗死(AMI)。其中,STEMI患者的平均住院费为4.05万元,院内死亡率也从2019年的3.29%攀升为3.48%,为中国心血管疾病带来了沉重负担,已然成为了重大的公共卫生问题。

在临床治疗中,以阿司匹林联合氯吡格雷为主的双联抗血小板治疗(DAPT)是ACS患者的抗栓基础,但仍存在依从性较低的治疗现状。据CPACS2研究统计,在该研究纳入的15,141ACS成年住院患者中,仅19.4%持续DAPT12个月。

北京大学第一医院心血管内科霍勇主任介绍:双联抗血小板治疗长期以来一直是冠心病尤其是ACS患者治疗过程中极为重要的一环。此次上市的氯吡格雷阿司匹林片——单片复方制剂(SPC),将通过其采用的特殊工艺‘Tab in tab’(片中片),使阿司匹林在肠道释放,不在胃部溶解,并快速起效,进而减少阿司匹林引起的胃肠道不良反应。同时,每日一片的给药方式,在降低患者用药负担的同时,也大大提升了患者的用药依从性,进一步改善了患者的临床预后。

多立维®是基于药物相互作用理论制成的多活性组分制剂,即利用药物相互作用的有益因素,对药物的整体治疗效应进行改善,提高患者依从性1。这一结果也在全球多个临床研究中得到了证实:

  • 一项为期30天的法国临床研究,旨在评估抗血小板治疗药物在经皮冠状动脉介入治疗的ACS患者中的应用。该研究共纳入390例患者,并且最终结果证实,SPC组的不依从率为7%,显著低于氯吡格雷加阿司匹林单药联合组的17%
  • 一项为期12个月的意大利社区研究,旨在评估双联抗血小板治疗药物在ACS患者中的应用。该研究共纳入26,834名患者,并且最终结果证实,SPC组依从率为81.5%,高于氯吡格雷加阿司匹林单药联合组的72.9%

赛诺菲大中华区总裁贺恩霆博士(Pius S. Hornstein, PhD)表示:心血管疾病是中国居民的主要致死疾病之一。赛诺菲非常骄傲能够持续为中国患者带来创新药物以改善人们的生活,此次多立维®的成功上市是我们坚持不懈地推出创新疗法的又一力证。我们在追寻科学奇迹,帮助人们焕发生命光彩的同时,将始终保持创新精神为更多中国患者带来切实有效的治疗选择和解决方案。

参考资料

1,徐亚伟,张书宁.氯吡格雷/阿司匹林单片复方制剂抗血小板治疗中国专家共识[J].中国介入心脏病学杂志,2021,29(06):306-312.

2,Deharo P, et al. Int J Cardiol 2014. 172(1): e1-e2;

3,Maggioni AP, et al. Eur Heart J Acute Cardiovasc Care 2019. 8(6): 527-535.

4,刘江萍木胡牙提急性冠脉综合征流行病学及危险因素的研究进展[J]. 国际心血管病杂志, 2019, 46(1):4.

5,中国胸痛中心联盟,中国心血管健康联盟,苏州工业园区心血管健康研究院等《中国胸痛中心质控报告(2020)》概要中国介入心脏病学杂志,2021296):313-317.

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    2022-05-23 yaanren
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    2022-05-23 fyxzlh
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