伦博雷沙坦对≥65 岁失眠症成人的疗效。

IF 3.9 3区医学 Q1 CLINICAL NEUROLOGY Neurology and Therapy Pub Date : 2024-08-01 Epub Date: 2024-05-15 DOI:10.1007/s40120-024-00622-9

Valerie Arnold, Sonia Ancoli-Israel, Thien Thanh Dang-Vu, Kazuo Mishima, Kate Pinner, Manoj Malhotra, Margaret Moline

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引用次数: 0

摘要

背景：失眠是一种常见的、负担沉重的睡眠障碍，药物治疗可用于治疗失眠，但对于易受促进睡眠药物副作用影响的老年人来说，药物治疗可能是禁忌症。这些对E2006-G000-303研究（303研究）睡眠日记数据的分析调查了5毫克（LEM5）和10毫克（LEM10）左旋眠痛对年龄≥65岁失眠亚组的益处：303号研究是一项为期12个月的双盲研究，对患有失眠症（睡眠开始和/或维持困难）的成人（年龄≥18岁）进行LEM5和LEM10治疗，评估受试者报告的（主观）睡眠开始潜伏期（sSOL）、睡眠效率（sSE）、睡眠开始后觉醒（sWASO）和总睡眠时间（sTST）。此外，还对晨睡/倦怠、失眠严重程度（失眠严重程度指数[ISI]）、疲劳（疲劳严重程度量表[FSS]）、对睡眠相关药物效果的感知（患者整体印象-失眠[PGI-I]问卷）以及安全性进行了评估：在这个老年人亚组（≥ 65 岁；n = 262）中，LEM5 和 LEM10 与安慰剂相比，sSOL、sSE、sTST 和 sWASO 在第 6 个月（sWASO 第 1 个月除外）与基线相比有显著变化，表明情况有所改善；这些改善持续到第 12 个月。在第 6 个月，服用一种或两种 LEM 剂量的受试者与服用安慰剂的受试者相比，晨间警觉性明显提高，而且这种提高一直持续到第 12 个月。在第 1、3 和 6 个月，服用 LEM 与服用安慰剂相比，ISI 总分和日间功能得分从基线下降（改善）的幅度明显更大（总分：两种剂量；日间功能：LEM5 第 1 个月和两种剂量）：总分：两种剂量；日间功能：LEM5 第 1 个月，两种剂量第 3 个月和第 6 个月），FSS 在第 1 个月和第 3 个月（LEM5）以及第 6 个月（两种剂量）从基线下降，并持续到第 12 个月。与安慰剂相比，更多受试者表示 LEM（两种剂量）对睡眠能力、入睡时间和 TST 有积极影响，影响持续到第 6 个月和第 12 个月，停药后无反弹。LEM在第12个月的耐受性良好；轻度嗜睡是最常见的治疗突发不良事件：结论：LEM治疗年龄≥65岁的成人失眠症的疗效改善早在治疗第一周就能观察到，并能持续到第12个月。LEM的耐受性良好：临床试验注册：ClinicalTrials.gov 识别码 NCT02952820：E2006-G000-303；研究 303；SUNRISE-2（首次发布时间：2016 年 10 月）；EudraCT 2015-001463-39（首次发布时间：2016 年 11 月）。

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Efficacy of Lemborexant in Adults ≥ 65 Years of Age with Insomnia Disorder.

Background: Pharmacologic treatments are available to treat insomnia, a common and burdensome sleep disorder, but may be contraindicated in older adults who are prone to side effects from sleep-promoting drugs. These analyses of sleep diary data from Study E2006-G000-303 (Study 303) investigated the benefits of lemborexant 5 mg (LEM5) and 10 mg (LEM10) in the subgroup age ≥ 65 years with insomnia.

Method: Study 303, a 12-month, double-blind study of LEM5 and LEM10 in adults (age ≥ 18 years) with insomnia disorder (sleep onset and/or maintenance difficulties) assessed subject-reported (subjective) sleep-onset latency (sSOL), sleep efficiency (sSE), wake after sleep onset (sWASO), and total sleep time (sTST). Morning sleepiness/alertness, insomnia severity (Insomnia Severity Index [ISI]), fatigue (Fatigue Severity Scale [FSS]), perceptions of sleep-related medication effects (Patient Global Impression-Insomnia [PGI-I] questionnaire), and safety were also evaluated.

Results: In this subgroup of older adults (≥ 65 years; n = 262), there were significantly larger changes from baseline for sSOL, sSE, sTST, and sWASO with LEM5 and LEM10 versus placebo through month 6 (except sWASO month 1), indicating improvement; these improvements were sustained through month 12. Subject-reported increases in morning alertness were significantly greater with one or both LEM doses versus placebo through month 6 and sustained through month 12. There were significantly larger ISI total and daytime functioning score decreases (improvement) from baseline with LEM versus placebo at months 1, 3, and 6 (total score: both doses; daytime functioning: LEM5 month 1 and both doses months 3 and 6) and decreases from baseline FSS at months 1 and 3 (LEM5) and month 6 (both doses), sustained to month 12. Compared with placebo, more subjects reported that LEM (both doses) positively impacted ability to sleep, time to fall asleep, and TST through month 6, sustained to month 12, with no rebound after drug withdrawal. LEM was well tolerated to month 12; mild somnolence was the most common treatment-emergent adverse event.

Conclusions: Improvements in subject-reported efficacy in LEM-treated adults age ≥ 65 years with insomnia were observed as early as the first week of treatment and sustained through end of month 12. LEM was well tolerated.

Clinical trials registration: ClinicalTrials.gov identifier NCT02952820: E2006-G000-303; Study 303; SUNRISE-2 (First posted: October 2016); EudraCT 2015-001463-39 (First posted: November 2016).

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来源期刊

Neurology and Therapy CLINICAL NEUROLOGY-

CiteScore

5.40

自引率

8.10%

发文量

103

审稿时长

6 weeks

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