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Diabetic Med:阿利库单抗安全性如何?

2018-12-28 MedSci MedSci原创

近日,国际杂志 《Diabetic Med》上在线发表一项关于在有和无糖尿病患者中使用的阿利库单抗的安全性-来自14个ODYSSEY试验的汇总数据的研究。根据糖尿病状态评估前蛋白转化酶枯草杆菌蛋白酶/ kexin 9型(PCSK9)抑制剂阿利库单抗的安全性。 研究人员通过治疗(阿利库单抗或安慰剂/依泽替米贝对照)和糖尿病状态(是/否,由病史定义)分析来自14个试验(8-104周持续时间)的

近日,国际杂志 《Diabetic Med》上在线发表一项关于在有和无糖尿病患者中使用的阿利库单抗的安全性-来自14ODYSSEY试验的汇总数据的研究。根据糖尿病状态评估前蛋白转化酶枯草杆菌蛋白酶/ kexin 9型(PCSK9)抑制剂阿利库单抗的安全性。

研究人员通过治疗(阿利库单抗或安慰剂/依泽替米贝对照)和糖尿病状态(是/否,由病史定义)分析来自14个试验(8-104周持续时间)的安全性数据。使用描述性统计和Cox模型评估不良事件数据。

5234名试验参与者中,1554名(29.7%)患有糖尿病。总体而言,阿利库单抗和对照组的治疗引起的不良事件相似,除了与更频繁阿利库单抗的局部注射部位反应。与没有糖尿病的人[阿利库单抗,7.5; 控制,4.9; 风险比1.5195CI 1.13-2.01]相,糖尿病患者的局部注射部位反应较少[阿利库单抗,3.5%,对照组,2.9; 风险比1.2495CI 0.68-2.25]。糖尿病患者报告的严重不良事件(阿利库单抗,19.4;对照组,19.7%)的数量多于非糖尿病患者(阿利库单抗,14.5;对照组,13.5%)。在糖尿病患者中,主要的心脏不良事件发生在2.7%的阿利库单抗治疗患者[对照组,3.3%;风险比0.7495CI 0.41-1.35]; 在没有糖尿病的人中,1.8%的阿利库单抗治疗的人有严重的心脏不良事件[对照组,1.7; 风险比0.9595CI 0.56-1.62]。总的来说,无论糖尿病状态如何,与对照组相比,HbA1C或空腹血糖均没有增加。

这项集中分析了14个试验,结果显示,不管糖尿病状况如何,阿利库单抗与对照组治疗的安全性相似,除了与阿利库单抗更频繁的局部注射部位反应。糖尿病患者报告的局部注射较少。

原始出处:

L. A. LeiterF. J. TinahonesD. G. Karaliset al. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials

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    有用

    0

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