索里昂®（solriamfetol）治疗对阻塞性睡眠呼吸暂停或发作性睡病患者体重的影响。
Effects of solriamfetol treatment on body weight in participants with obstructive sleep apnea or narcolepsy.
机构信息
Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego Medical Center, La Jolla, CA, USA.
University of Pittsburgh/Veterans Administration Pittsburgh Health System, Pittsburgh, PA, USA.
出版信息
Sleep Med. 2022 Dec;100:165-173. doi: 10.1016/j.sleep.2022.08.005. Epub 2022 Aug 14.
OBJECTIVES
This analysis characterized changes in weight in participants with obstructive sleep apnea (OSA) or narcolepsy treated with solriamfetol (Sunosi™) 37.5 (OSA only), 75, 150, or 300 mg/d.
METHODS
In two 12-week, randomized, placebo-controlled trials and one 1-year open-label extension study, changes in weight were evaluated from baseline to end of study (week 12 or week 40 of the open-label extension [after up to 52 weeks of solriamfetol treatment]) in participants with OSA or narcolepsy.
RESULTS
After 12 weeks of solriamfetol treatment, median percent change in weight from baseline across all solriamfetol doses was -0.84%, compared with 0.54% for placebo, in participants with OSA; and -0.07%, compared with 3.08% for placebo, in participants with narcolepsy. After up to 52 weeks of solriamfetol treatment, overall median percent change in weight from baseline was -1.76%, which showed a dose-dependent pattern (75 mg, 0.57%; 150 mg, -1.2%; 300 mg, -2.5%). Results were similar in subgroups of participants with OSA or narcolepsy, with overall median percent changes in weight of -2.2% and -1.1%, respectively. After up to 52 weeks of solriamfetol treatment, the percentage of participants with weight loss ≥5% relative to baseline was 25.7% overall and increased in a dose-dependent manner (75 mg, 4.5%; 150 mg, 17.3%; 300 mg, 32.4%). Results were similar among subgroups of participants with OSA or narcolepsy, with 26.4% and 24.2% of participants experiencing weight loss ≥5%, respectively. No weight-related treatment-emergent adverse events were serious.
CONCLUSIONS
Solriamfetol treatment was associated with decreases in body weight in a dose-related manner.
目的
本分析旨在描述接受索里昂（Sunosi™）37.5mg（仅用于 OSA）、75mg、150mg 或 300mg/d 治疗的阻塞性睡眠呼吸暂停（OSA）或发作性睡病患者的体重变化。
方法
在两项为期 12 周、随机、安慰剂对照试验和一项为期 1 年的开放标签扩展研究中，在 OSA 或发作性睡病患者中，从基线到研究结束（12 周或开放标签扩展的第 40 周[在接受索里昂治疗最多 52 周后]）评估体重变化。
结果
在接受索里昂治疗 12 周后，与安慰剂相比，所有索里昂剂量组的 OSA 患者体重从基线的中位数百分比变化为-0.84%，而安慰剂组为 0.54%；在发作性睡病患者中，索里昂组为-0.07%，安慰剂组为 3.08%。在接受索里昂治疗最多 52 周后，体重从基线的总体中位数百分比变化为-1.76%，呈现出剂量依赖性模式（75mg，0.57%；150mg，-1.2%；300mg，-2.5%）。在 OSA 或发作性睡病患者的亚组中，体重变化的中位数百分比也相似，体重分别降低 2.2%和 1.1%。在接受索里昂治疗最多 52 周后，体重相对于基线减轻≥5%的患者百分比为 25.7%，呈剂量依赖性增加（75mg，4.5%；150mg，17.3%；300mg，32.4%）。在 OSA 或发作性睡病患者的亚组中，体重减轻≥5%的患者比例分别为 26.4%和 24.2%。无与体重相关的治疗引起的不良事件严重。
结论
索里昂治疗与体重呈剂量相关的下降有关。
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