替西肽治疗对伴有阻塞性睡眠呼吸暂停和肥胖的SURMOUNT-OSA患者报告结果的影响。

IF 3.4 2区 医学 Q1 CLINICAL NEUROLOGY
Sleep medicine Pub Date : 2025-10-01 Epub Date: 2025-08-06 DOI:10.1016/j.sleep.2025.106719
Chisom Kanu, Shraddha Shinde, Sujatro Chakladar, Ellen B Dennehy, Terri E Weaver, Jiat Ling Poon, Atul Malhotra
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引用次数: 0

摘要

目的:在SURMOUNT-OSA 3期试验中,替西帕肽治疗可显著降低中度至重度阻塞性睡眠呼吸暂停(OSA)和肥胖患者的呼吸暂停低通气指数(AHI)。我们评估了替西肽治疗对睡眠障碍、睡眠相关障碍、功能、健康相关生活质量(HRQoL)和OSA患者症状的影响。方法:SURMOUNT-OSA包括两项随机,安慰剂对照试验,替西帕肽(10 mg或15 mg)或安慰剂,在中重度OSA和肥胖患者中进行52周。对于使用PAP的参与者(研究2),在进行多导睡眠图和患者报告的结果测量(PROMs)评估之前撤销PAP。预先指定的PROM终点从基线到第52周。使用协方差分析评估睡眠相关障碍、睡眠障碍、白天过度嗜睡、功能和HRQoL的变化。描述了OSA症状严重程度的分类变化。结果:在第52周,与安慰剂相比,替西肽治疗的参与者报告了显著改善的患者报告结果测量信息系统(PROMIS)短表睡眠相关障碍8a评分,PROMIS短表v1.0睡眠障碍8b评分,睡眠功能结果问卷活动水平评分,EQ-5D-5L评分,以及短表36健康调查的大多数领域,版本2。与安慰剂相比,替西帕肽治疗在患者总体印象状态和患者总体印象变化症状量表上也有更大的改善。此外,研究1的参与者报告了Epworth嗜睡量表得分的显著变化。结论:结果表明,除了改善AHI、与OSA相关的缺氧负担和心血管危险因素等客观结果外,OSA患者报告在替西帕肽治疗后症状、功能和HRQoL均有改善。临床试验:政府编号:NCT05412004。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Effect of tirzepatide treatment on patient-reported outcomes among SURMOUNT-OSA participants with obstructive sleep apnea and obesity.

Aim: In the phase 3 SURMOUNT-OSA trials, tirzepatide treatment significantly reduced the apnea-hypopnea index (AHI) among people with moderate-to-severe obstructive sleep apnea (OSA) and obesity. We evaluated effects of tirzepatide treatment on sleep disturbance, sleep-related impairment, functioning, health-related quality of life (HRQoL), and OSA symptoms in SURMOUNT-OSA participants.

Methods: SURMOUNT-OSA consisted of two randomized, placebo-controlled trials of tirzepatide (10 mg or 15 mg) or placebo for 52 weeks in participants with moderate-to-severe OSA and obesity. For participants using PAP (Study 2), PAP was withdrawn prior to assessments of polysomnography and patient-reported outcome measures (PROMs). Prespecified PROM endpoints were from baseline to Week 52. Changes in sleep-related impairment, sleep disturbance, excessive daytime sleepiness, functioning, and HRQoL were assessed using analysis of covariance. Categorical shifts in OSA symptom severity were described.

Results: At Week 52, compared with placebo, tirzepatide-treated participants reported significantly improved Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form Sleep-related Impairment 8a scores, PROMIS Short-Form v1.0 Sleep Disturbance 8b scores, Functional Outcomes of Sleep Questionnaire Activity-Level scores, EQ-5D-5L scores, and most domains of the Short-Form 36 Health Survey, Version 2. Tirzepatide treatment was also associated with greater improvements in Patient Global Impression of Status and Patient Global Impression of Change symptom scales compared with placebo. Additionally, Study 1 participants reported significant changes in Epworth Sleepiness Scale scores.

Conclusion: Results indicate that in addition to objective outcomes of improved AHI, hypoxic burden associated with OSA, and cardiovascular risk factors, people with OSA reported benefits in symptoms, functioning, and HRQoL following tirzepatide treatment.

Clinicaltrials:

Gov number: NCT05412004.

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来源期刊
Sleep medicine
Sleep medicine 医学-临床神经学
CiteScore
8.40
自引率
6.20%
发文量
1060
审稿时长
49 days
期刊介绍: Sleep Medicine aims to be a journal no one involved in clinical sleep medicine can do without. A journal primarily focussing on the human aspects of sleep, integrating the various disciplines that are involved in sleep medicine: neurology, clinical neurophysiology, internal medicine (particularly pulmonology and cardiology), psychology, psychiatry, sleep technology, pediatrics, neurosurgery, otorhinolaryngology, and dentistry. The journal publishes the following types of articles: Reviews (also intended as a way to bridge the gap between basic sleep research and clinical relevance); Original Research Articles; Full-length articles; Brief communications; Controversies; Case reports; Letters to the Editor; Journal search and commentaries; Book reviews; Meeting announcements; Listing of relevant organisations plus web sites.
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