TY - T1的疗效和安全性的Lemborexant老年人失眠障碍:SUNRISE-1的汇总分析和SUNRISE-2乔(1860)JF -神经-神经学六世- 94 - 15补充SP - 1860 AU -玛格丽特风车式的非盟-简Yardley AU -凯特平纳盟迪Kumar AU -穆罕默德Bshar首页at盟Mikko Karppa AU -加里Zammit AU -卡洛斯佩尔多莫坚称盟卡罗琳Mianulli AU -拉塞尔·罗森博格Y1 - 2020/04/14 UR - //www.ez-admanager.com/content/94/15_Supplement/1860.abstract N2 -目的:检查双促食素受体拮抗剂的临床疗效和安全性Lemborexant (LEM)治疗受试者年龄≥65 y。背景:在SUNRISE-1 (NCT02783729;e2006 - g000 - 304)和SUNRISE-2 (NCT02952820;e2006 - g000 - 303),登月舱(5毫克(LEM5); 10毫克[LEM10])提供了大量有利于睡眠发作和维护与安慰剂,耐受性良好。这汇集分析研究小组的研究结果老年人(年龄≥65岁y)超过1个月。设计/方法:SUNRISE-1是一个月,双盲,安慰剂——active-controlled(唑吡坦延长释放;没有报告)研究对象年龄≥55 y失眠障碍。SUNRISE-2是12个月,6个安慰剂对照双盲研究,然后6个仅时期。受试者≥18 y失眠障碍。1006年和949年的主题在各自SUNRISE-1和SUNRISE-2全分析集,595 (30.4%)≥65 y(安慰剂,n = 182;LEM5 n = 205;LEM10, n = 208)。 Here we analyzed change from baseline (CFB) in self-reported (subjective) sleep parameters in this subgroup using a mixed-effect repeated measurement analysis, adjusted for relevant factors.Results: At the end of 1 month, median subjective sleep onset latency (min) was significantly reduced from baseline with LEM versus placebo (placebo, −4.6; LEM5, −18.1; LEM10, −17.1; both P<0.0001). Subjective sleep efficiency (total sleep time/time in bed) significantly increased from baseline with LEM versus placebo (least squares mean [LSM] CFB: placebo, 6.1%; LEM5, 10.9%; LEM10, 12.5%; both P<0.001). Subjective wake after sleep onset was reduced from baseline with LEM versus placebo; the decrease with LEM10 was significant (LSM CFB: PBO, −24.1; LEM5, −34.5 [P=0.07], LEM10, −40.4 [P=0.0049]). Treatment-emergent adverse events with incidence >5% in either LEM group and >PBO in the PBO, LEM5, and LEM10 groups, respectively, were somnolence (1.1%, 6.5%, 13.1%) and headache (5.5%, 7.7%, 4.9%); no deaths occurred.Conclusions: The observed efficacy and safety profile of LEM in this ≥65y subgroup supports its development as a potential treatment option for insomnia in the elderly.Disclosure: Dr. Moline has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Eisai Inc. Dr. Yardley has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Eisai Ltd. Dr. Pinner has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Eisai Ltd. Dr. Kumar has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Eisai Inc. Dr. Bsharat has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai Inc. Dr. Karppa has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Amgen, Eisai Inc., Teva Pharmaceuticals. Dr. Zammit has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employmee of Clinilabs Drug Development Corporation, Consultant: Eisai Inc., Janssen Pharmaceutical, Purdue, and Takeda. Dr. Perdomo has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Eisai Inc. Dr. Miai has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of NeuroTrials Inc. Dr. Rosenberg has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with received consultancy fees from Eisai; honoraria from Merck; research funding from Jazz Pharmaceuticals, Merck, Actelion, Eisai, and Philips Respironics; and has served on the speakers’ bureau for Merck and as an advisory board member for Jazz Pharmaceutic. Dr. Rosenberg has received research support from Eisai, Jazz, Idorsia. ER -