P.020 LEMBOREXANT 治疗 6 个月后失眠严重程度量表中日间功能项目的变化

C. Chepke, K. Cote, K. Pinner, J. Yardley, M. Moline
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引用次数: 0

摘要

背景:在改善失眠症的同时,日间功能也应得到改善。根据失眠的基线严重程度,我们分析了在接受雷博瑞坦(LEM)(一种双重奥曲肽受体拮抗剂)或安慰剂(PBO)治疗后,失眠严重程度指数(ISI)白天相关项目的得分。研究方法E2006-G000-303是一项为期12个月的随机、双盲、PBO对照研究(前6个月:治疗期1 [TP1]),患有失眠症的参与者(≥18岁)被随机分配到PBO或5毫克(LEM5)或10毫克(LEM10)的LEM治疗中,为期6个月。ISI项目分为0分(无问题)至4分(问题非常严重);与白天相关的ISI项目最高分为16分。结果:在 949 名参与者中,有 749 人(78.9%)在基线和 TP1 结束时完成了 ISI。各组的基线日间 ISI 总分分布相似。与 PBO(26.6% 和 29.6%)相比,LEM5(分别为 49.7% 和 39.1%)和 LEM10(分别为 46.2% 和 46.3%)组有更多基线分数为 9-12 分和 13-16 分的参与者转为 0-4 分。总的班次分布有明显差异,LEM 两组均占优(P<0.01)。LEM 的耐受性良好。结论与 PBO 治疗组相比,LEM 治疗组有更多参与者的日间功能得到改善,这体现在有更多参与者的评分进入较低类别(即睡眠改善),这表明除了改善睡眠参数外,LEM 还具有其他价值。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
P.020 Shifts in daytime functioning items on the insomnia severity scale with lemborexant after 6 months of treatment
Background: Improvements in daytime functioning ideally accompany improvements in insomnia. Scores on the Insomnia Severity Index (ISI) daytime-related items were analyzed following treatment with lemborexant (LEM), a dual orexin receptor antagonist, or placebo (PBO), based on baseline severity. Methods: Participants (≥18 y) with insomnia disorder in E2006-G000-303, a 12-month, randomized, double-blind, PBO-controlled study (first 6 months: Treatment Period 1 [TP1]), were randomized to PBO or LEM 5 mg (LEM5) or 10 mg (LEM10) for 6 months. ISI items are rated 0 (no problem) to 4 (very severe problem); daytime-related ISI items have a maximum score of 16. Results: Of 949 participants, 749 (78.9%) completed the ISI at baseline and end of TP1. Baseline daytime ISI total score distributions were similar between groups. More participants with baseline scores of 9-12 and 13-16 shifted to 0-4 with LEM5 (49.7% and 39.1%, respectively) and LEM10 (46.2% and 46.3%) versus PBO (26.6% and 29.6%). Overall shift distributions were significantly different, favoring both LEM groups (P<0.01). LEM was well tolerated. Conclusions: More LEM-treated participants had improved daytime functioning, evidenced by the significantly larger number of participants whose scores moved into lower categories (ie, better sleep) versus PBO-treated participants, demonstrating additional value beyond improved sleep parameters.
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