治疗慢性失眠症患者的 Daridorexant:治疗所需人数、伤害所需人数以及得到帮助或受到伤害的可能性。

Postgraduate medicine Pub Date : 2024-05-01 Epub Date: 2024-06-13 DOI:10.1080/00325481.2024.2359891
François-Xavier Chalet, Pierre-Philippe Luyet, Cristina Rabasa, Cédric Vaillant, Paul Saskin, Ajay Ahuja, Leslie Citrome
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摘要

研究目标从治疗所需人数(NNT)、伤害所需人数(NNH)和受帮助或伤害的可能性(LHH)的角度,评估达立骨化醇 50 毫克和 25 毫克与安慰剂相比治疗慢性失眠症的证据:NNT、NNH 和 LHH 是根据一项为期 3 个月的关键性 3 期研究计算得出的(N = 930;按 1:1:1 随机分配至 daridorexant 50 毫克、daridorexant 25 毫克或安慰剂,每晚一次)。NNT疗效分析采用了睡眠开始后的觉醒度、持续睡眠潜伏期、自我报告的总睡眠时间、失眠日间症状和影响问卷(IDSIQ)以及失眠严重程度指数。NNH 安全性分析采用的是任何治疗组中不良事件(AEs)发生率大于 1%的参试者。对所有NNT估计值进行了LHH评估,并将其与嗜睡、头痛和疲劳AEs的NNH估计值进行对比:daridorexant 50 mg与安慰剂相比的NNT估计值为1(daridorexant 25 mg在IDSIQ警觉/认知领域除外),表明患者更有可能对daridorexant 50 mg和25 mg产生反应,而不是出现嗜睡、头痛或疲劳等AE:结论:达立停 50 毫克和 25 毫克在 3 个月内的获益-风险比良好。Daridorexant 50 毫克与安慰剂相比,其 NNT 估计值比 daridorexant 25 毫克更高(更低)。
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Daridorexant for patients with chronic insomnia disorder: number needed to treat, number needed to harm, and likelihood to be helped or harmed.

Objectives: Appraise the evidence for daridorexant 50 mg and 25 mg versus placebo when treating chronic insomnia disorder in terms of number needed to treat (NNT), number needed to harm (NNH), and likelihood to be helped or harmed (LHH).

Methods: NNT, NNH, and LHH were calculated from a 3-month pivotal Phase 3 study (N = 930; randomized 1:1:1 to daridorexant 50 mg, daridorexant 25 mg, or placebo once nightly). Wakefulness after sleep onset, latency to persistent sleep, self-reported total sleep time, Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ), and Insomnia Severity Index were used for the NNT efficacy analysis. NNH safety analysis was performed using rates of adverse events (AEs) occurring in >1% of the participants in any arm. LHH was assessed for all NNT estimates, contrasting them with NNH estimates for somnolence, headache, and fatigue AEs.

Results: NNT estimates for daridorexant 50 mg versus placebo were <10 for clinically meaningful thresholds across all outcomes. NNT estimates for daridorexant 25 mg versus placebo were not as robust as those observed for daridorexant 50 mg, with many values exceeding 10. NNH estimates for daridorexant 50 mg and 25 mg versus placebo did not show a statistically significant treatment difference except for falls, where NNH was negative for the daridorexant 50 mg group (-44 [95% CI -328; -21]; rate of falls was greater with placebo than for daridorexant 50 mg). All LHH ratios at Months 1 and 3 were >1 (except for daridorexant 25 mg for the IDSIQ alert/cognition domain), indicating that patients were more likely to respond to daridorexant 50 mg and 25 mg than to experience an AE of somnolence, headache, or fatigue.

Conclusion: Daridorexant 50 mg and 25 mg have a favorable benefit-risk ratio over 3 months. Daridorexant 50 mg demonstrated more robust (lower) NNT estimates versus placebo than daridorexant 25 mg.

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