文摘
摘要目的:锋利的研究评估是否solriamfetol改善日间极度嗜睡患者认知功能(EDS)与阻塞性睡眠呼吸暂停(OSA)和现存的认知障碍。
背景:阻塞性睡眠呼吸暂停综合症是一种常见疾病,其特征是重复间歇性缺氧事件导致中断睡眠和EDS。正压通气(PAP)减少缺氧事件和减轻睡眠中断,但EDS往往仍然存在。认知障碍是一个繁重的症状在许多患者EDS与阻塞性睡眠呼吸暂停综合症,导致职业和社会功能障碍和降低生活质量。Solriamfetol (Sunosi®)批准与EDS改善成年人的觉醒与阻塞性睡眠呼吸暂停综合症有关。在临床前药理学研究中,solriamfetol抑制多巴胺和去甲肾上腺素再摄取和激活跟踪amine-associated受体1 (TAAR1),潜在的认知中受益。
设计/方法:夏普是一个随机、双盲,安慰剂对照,交叉试验的患者59 EDS与阻塞性睡眠呼吸暂停综合症,并演示了认知障碍有关。所有患者接受solriamfetol(75毫克,3天之后,150毫克/天)2周,2周和安慰剂,治疗时间相隔一周惨败。主要终点是改变从基线数字符号替换电池测试的可重复的评估神经心理状态(DSST-RBANS)。二次端点包括改变基线在不列颠哥伦比亚省认知投诉库存(BC-CCI)和埃普沃思嗜睡量表(ESS)。
结果:研究完成率为96.7%。Solriamfetol治疗提高性能的DSST-RBANS相比安慰剂(6.49 vs 4.75, p = 0.009),与(科恩的大小产生影响d0.36)。Solriamfetol治疗也取得了改善BC-CCI (−4.70 vs−3.11, p = 0.002;d= 0.43)和ESS (−4.41 vs−2.31, p = 0.004;d =0.50)。最常见的不良事件与solriamfetol治疗(发生率≥3%)恶心(6.9%)和焦虑(3.4%)。
结论:Solriamfetol(150毫克/天)客观和主观的措施改善患者的认知功能的EDS与阻塞性睡眠呼吸暂停综合症和认知障碍。
披露:范教授幅已收到个人薪酬在5000 - 9999美元的范围作为顾问爵士药品。范教授幅已收到个人薪酬在500 - 4999美元的范围为卫材担任顾问。范教授幅已收到个人薪酬在500 - 4999美元的范围作为一个演讲者在虚拟会议美国睡眠医学学会。范教授幅已收到个人补偿的范围0 - 499美元作为评论家的AAA的基础。Leary博士获得了个人作为一个雇员补偿爵士药品。Leary博士已经收到个人薪酬在10000 - 49999美元的范围作为顾问。利瑞博士的股票爵士药品。德雷克博士已经收到个人薪酬在500 - 4999美元的范围为卫材担任顾问。德雷克博士已经收到个人薪酬在10000 - 49999美元的范围在卫材的演讲人。德雷克博士已经收到个人薪酬在10000 - 49999美元的范围在生物科学和谐的演讲人。 The institution of Dr. Drake has received research support from Jazz. The institution of Dr. Drake has received research support from Suven. The institution of Dr. Drake has received research support from P&G. The institution of Dr. Drake has received research support from Axsome. Dr. Drake has received publishing royalties from a publication relating to health care. Dr. Bogan has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Harmony. Dr. Bogan has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Jazz. Dr. Bogan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Takeda. Dr. Bogan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Avadel. Dr. Bogan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Merck. Dr. Bogan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Harmony. Dr. Bogan has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Jazz. The institution of Dr. Bogan has received research support from Jazz Pharmaceuticals. The institution of Dr. Bogan has received research support from Harmony . The institution of Dr. Bogan has received research support from Philips. The institution of Dr. Bogan has received research support from Eisai. The institution of Dr. Bogan has received research support from Fresca. The institution of Dr. Bogan has received research support from Avadel. The institution of Dr. Bogan has received research support from Takeda. The institution of Dr. Bogan has received research support from Suven. The institution of Dr. Bogan has received research support from Axsome. Dr. Bogan has received intellectual property interests from a discovery or technology relating to health care. Dr. Bogan has a non-compensated relationship as a Chair with National Sleep Foundation that is relevant to AAN interests or activities. Judith Jaeger has received personal compensation for serving as an employee of CognitionMetrics, LLC. Mr. Rosenberg has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eisai. The institution of Mr. Rosenberg has received research support from Neurotrials Research. Caroline Streicher has received personal compensation for serving as an employee of Axsome Therapeutics. Caroline Streicher has stock in Axsome Therapeutics. Miss Kwak has received personal compensation for serving as an employee of Axsome Therapeutics. Miss Kwak has stock in Axsome Therapeutics. Dr. Bates has received personal compensation for serving as an employee of Axsome Therapeutics. Dr. Bates has stock in Axsome Therapeutics. Dr. Tabuteau has received personal compensation for serving as an employee of Axsome Therapeutics. Dr. Tabuteau has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Axsome Therapeutics. Dr. Tabuteau has received stock or an ownership interest from Axsome Therapeutics. Dr. Tabuteau has received intellectual property interests from a discovery or technology relating to health care.
