在受CPAP治疗或不接受CPAP治疗的阻塞性睡眠呼吸暂停患者中治疗过度白天嗜睡的Pitolisant 40 mg:随机的第三阶段研究
Yves Dauvilliers1, Sonya Elizabeth Craig2, Maria R Bonsignore3
1Centre National de Référence Narcolepsie, Unité du Sommeil, CHU Montpellier, Hôpital Gui-de-Chauliac, Service de Neurologie, Université de Montpellier, INSERM INM, Montpellier, France.
Journal of sleep research
|October 8, 2024
概括
皮托利桑特有效治疗阻塞性睡眠呼吸暂停 (OSA) 患者的过度白天嗜睡 (EDS). 这项研究表明,每天高达40毫克的皮托利桑特显著改善了嗜睡和反应时间,无论CPAP使用情况如何.
科学领域:
- 睡眠医学 睡眠医学
- 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:
- 阻塞性睡眠呼吸暂停 (OSA) 是一种常见的疾病,通常会导致过度的白天嗜睡 (EDS).
- 持续正气道压力 (CPAP) 是一种标准的治疗方法,但有些患者仍然患有EDS.
- 皮托利桑 (Pitolisant) 是一种选择性组胺-3受体对抗剂,已在治疗OSA中的EDS方面表现出有效性.
研究的目的:
- 评估高剂量 (每天高达40毫克) 的皮托利桑特在中度至重度OSA患者的疗效和安全性.
- 评估Pitolisant在患有OSA的患者的有效性,与或没有同时CPAP治疗.
- 为了确定皮托利桑对嗜睡,反应时间和整体临床印象的影响.
主要方法:
- 一项3期,多中心,随机,双盲,安慰剂对照试验,涉及361名中度至重度OSA患者.
- 患者被分配2:1接受皮托利桑特 (定位至每天10,20或40毫克) 或安慰剂12周.
- 主要终点:爱普沃思睡眠度量 (ESS) 评分的变化;次要终点包括反应时间 (牛津睡眠阻力测试),CGI-C和PGOE.
主要成果:
- 与安慰剂相比,Pitolisant在12周内显著降低了ESS得分 (LS平均差异-2.6,p < 0.001).
- 观察到反应时间,临床总体变化印象 (CGI-C) 和患者对效应的总体看法 (PGOE) 的改善.
- 无论患者是否使用CPAP治疗,疗效都是一致的; 88.8%的皮托利桑特接受者在第3周服用了40毫克.
结论:
- 皮托利桑 (Pitolisant) 剂量高达40毫克,每天服用一次,是中度至重度OSA患者过度白天嗜睡的有效治疗方法.
- 治疗表明了有利的安全性,没有发现新的安全信号.
- 皮托利桑特为OSA患者的EDS提供了一种有价值的治疗选择,无论他们使用CPAP.
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