诺华III期临床研究显示ACZ885可降低心脏病发作幸存者心血管风险

2017-07-28 佚名 MedSci原创

  • III期CANTOS研究达到主要终点,即心脏病发作、卒中和心血管死亡复合终点,结果显示ACZ885(canakinumab)与标准治疗结合,可降低有心脏病发作病史和炎性动脉粥样硬化患者的心血管风险。
  • 尽管已采取当前的治疗手段,但由于炎性动脉粥样硬化的高风险性,仍有约40%的心脏病发作幸存者心脏病发作复发、卒中或心血管死亡的风险增加,25%的患者会在5年内发生另一心血管事件。
  • 全部研究结果即将在医学大会上公布,并且诺华计划就此与监管部门展开讨论。 

北京和上海2017年7月25日电 /美通社/ -- 诺华日前在巴塞尔公布了全球III期 CANTOS 研究的研究结果。该研究研究了 ACZ885(canakinumab)与标准治疗联合应用对有心脏病史和炎性动脉粥样硬化患者的有效性、安全性和耐受性。在过去六年中,该研究已纳入10000多例患者,CANTOS 是诺华历史上规模最大、历时最长的临床试验之一。

CANTOS 研究达到了主要终点,研究表明 ACZ885 与标准治疗联合应用,可降低有心脏病发作病史和炎性动脉粥样硬化患者的主要心血管不良事件(MACE)风险,即心血管死亡、非致死性心肌梗塞和非致死性卒中的复合风险。本研究的完整数据将在医学大会上提交,并于今年晚些时候在同行评审的出版物上发表。

诺华全球药品开发负责人兼首席医学官 Vas Narasimhan 表示:“尽管采用当前的治疗方法,仍有约25%的心脏病发作幸存者在5年内会发生另一心血管事件,因此 CANTOS 研究结果为患者带来了新的希望。ACZ885 是第一个也是唯一一个可降低心血管风险的选择性靶向炎症试验药物。目前,我们的首要任务是对这些重要数据进行彻底分析,并就此与监管机构进行讨论。”

欧盟每年约有58万人心脏病发作,仅在美国每年也有75万人发作。2015年全球心脏病发作的人数约为729万人。尽管已采用标准治疗,但有心脏病发作史的患者发生另一事件或死亡的风险依然较高。目前已证实,每10人中约有4人的发病或死亡风险与动脉粥样硬化相关的炎症增加直接相关。炎性动脉粥样硬化患者的 MACE 复发与高发病率、死亡率及生活质量下降有关,而且是目前世界各地患者和医疗体系的主要经济负担。

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    2018-06-18 juliusluan78
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