Study Objectives:

Excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA) affects 9%-22% of continuous positive airway pressure (CPAP)-treated patients. An indirect treatment comparison (ITC) meta-analysis was performed to compare efficacy and safety of medications (solriamfetol, modafinil, and armodafinil) approved to treat EDS associated with OSA.

Methods:

Efficacy and safety measures assessed in this ITC included Epworth Sleepiness Scale (ESS), 20-minute Maintenance of Wakefulness Test (MWT20), Clinical Global Impression of Change (CGI-C), Functional Outcomes of Sleep Questionnaire (FOSQ), and incidence of treatment-emergent adverse events (TEAEs; any, serious, or leading to discontinuation).

Results:

A systematic literature review (SLR) identified 6 parallel-arm, placebo-controlled randomized controlled trials (RCTs) that randomized 1714 total participants to placebo, solriamfetol, modafinil, or armodafinil. In this ITC, all comparators were associated with greater improvements than placebo on the ESS, the MWT20, and CGI-C after 4, 8 and 12 weeks of treatment. Relative to comparators and placebo at 12 weeks, solriamfetol at 150 mg or 300 mg had the highest probabilities of improvement in the ESS, MWT, and CGI-C. Modafinil (200 or 400 mg) and solriamfetol (150 or 300 mg) were associated with greater improvement on the FOSQ than placebo at 12 weeks. Less than 2% of patients using placebo or comparators experienced serious or discontinuation-related TEAEs.

Conclusions:

The results of this ITC show 12 weeks of treatment with solriamfetol, modafinil, and armodafinil resulted in varying levels of improvement on the ESS, MWT20, and CGI-C and similar safety risks in participants with EDS associated with OSA.

中文翻译：

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solriamfetol、莫达非尼和阿莫达非尼对阻塞性睡眠呼吸暂停患者白天过度嗜睡的间接治疗比较

学习目标：

与阻塞性睡眠呼吸暂停 (OSA) 相关的白天过度嗜睡 (EDS) 影响 9%-22% 的持续气道正压通气 (CPAP) 治疗患者。进行了一项间接治疗比较 (ITC) 荟萃分析，以比较批准用于治疗与 OSA 相关的 EDS 的药物（solriamfetol、莫达非尼和 armodafinil）的疗效和安全性。

方法：

本 ITC 评估的有效性和安全性措施包括 Epworth 嗜睡量表 (ESS)、20 分钟保持清醒测试 (MWT20)、临床总体变化印象 (CGI-C)、睡眠问卷的功能结果 (FOSQ) 和治疗中出现的不良事件（TEAE；任何、严重或导致停药）。

结果：

系统文献综述 (SLR) 确定了 6 项平行组、安慰剂对照随机对照试验 (RCT)，将 1714 名参与者随机分配至安慰剂、solriamfetol、莫达非尼或阿莫达非尼。在该 ITC 中，在治疗 4、8 和 12 周后，所有比较药物在 ESS、MWT20 和 CGI​​-C 方面的改善都比安慰剂更大。相对于 12 周时的对照品和安慰剂，150 毫克或 300 毫克的 solriamfetol 改善 ESS、MWT 和 CGI​​-C 的可能性最高。与安慰剂相比，莫达非尼（200 或 400 毫克）和 solriamfetol（150 或 300 毫克）与 FOSQ 相比在 12 周时有更大的改善。不到 2% 的使用安慰剂或对照药的患者出现严重或停药相关的 TEAE。

结论：

该 ITC 的结果显示，使用 solriamfetol、莫达非尼和阿莫达非尼治疗 12 周后，与 OSA 相关的 EDS 参与者的 ESS、MWT20 和 CGI​​-C 有不同程度的改善，以及类似的安全风险。