同时使用Etrasimod与阿片类药物或抗抑郁药在性结肠炎患者-A安全性分析
Anita Afzali1, Miguel Regueiro2, Andres J Yarur3
1Department of Internal Medicine, Division of Digestive Diseases, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
United European gastroenterology journal
|February 1, 2025
概括
治疗性结肠炎的Etrasimod显示,在与阿片类药物或抗抑郁药一起使用时,不良事件的发生率很低. 这表明UC患者同时服用这些药物的药物相互作用风险较低.
科学领域:
- 胃肠病学 胃肠病学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 埃特拉西莫德是一种口服的,选择性基-1-酸盐 (S1P) 1,4,5受体调节器,用于性结肠炎 (UC).
- 与ozanimod不同,埃特拉西莫德不抑制单胺氧化酶 (MAO),这可能会降低与MAO抑制剂药物相互作用相关的风险.
- 同时使用MAO抑制剂与阿片类药物和抗抑郁药可以增加不良事件 (AE) 的风险.
研究的目的:
- 评估在接受埃特拉西莫德和同时服用阿片类药物或抗抑郁药物的患者中可能与血清激素综合征相关的副作用的发生率.
- 评估来自第三期ELEVATE UC 52和ELEVATE UC 12试验的安全数据.
主要方法:
- 从两个第三阶段试验 (ELEVATE UC 52和ELEVATE UC 12) 收集的安全性数据进行了后期分析.
- 对每天服用2毫克埃特拉西莫德一次,同时服用阿片类药物或抗抑郁药或不服用阿片类药物的患者进行亚组分析.
- 评估患有至少一种可能与血清激素综合征相关的并发性AE患者的比例,包括高血压相关事件.
主要成果:
- 在接受埃特拉西莫德治疗的527名患者中,14.6%和6.6%分别同时服用阿片类药物或抗抑郁药.
- 可能与血清激素综合征相关的副作用的发生率,包括与高血压相关的事件,很低 (≤8.6%),并且在各子组中可比.
- 由于同时使用药物,没有报告严重的副作用或治疗中止.
结论:
- 在接受埃特拉西莫德治疗的患者中,与同时服用阿片类药物或抗抑郁药物或不服用阿片类药物或抗抑郁药物的患者中,副作用的发生率较低且可比.
- 这项分析支持埃特拉西莫德与UC患者的阿片类药物或抗抑郁药等常见处方药之间的临床相关药物相互作用的可能性很低.
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