Drake Christopher L, Yardley Jane, Pinner Kate, Moline Margaret, Malhotra Manoj
Thomas Roth Sleep Disorders and Research Center, Henry Ford Hospital, Detroit, MI, USA.
Clinical Evidence Generation, Neurology and Deep Human Biology Learning, Eisai Ltd., Hatfield, Hertfordshire, UK.
Nat Sci Sleep. 2025 Apr 8;17:557-570. doi: 10.2147/NSS.S499090. eCollection 2025.
Using data from a clinical study of lemborexant, evaluate responses to the Patient Global Impression-Insomnia (PGI-I) questionnaire, a simple 4-item questionnaire that assesses patients' perceptions of the effects of medication on sleep, which may help evaluate clinically meaningful changes from the patient's perspective.
Study E2006-G001-303, a 12-month, placebo (PBO)-controlled (first 6 months) Phase 3 study in adults with insomnia disorder, randomized subjects (1:1:1) to lemborexant 5 mg (LEM5; n=316), 10 mg (LEM10; n=315), or PBO (n=318). The second 6 months are not presented here. PGI-I results were analyzed post hoc in relation to patient-reported (subjective) sleep-onset latency (sSOL) and total-sleep-time (sTST).
At 6 months: 67.3% (LEM5) and 68.8% (LEM10) of subjects reported positive effects of medication helping them sleep versus 45.0% (both <0.0001) with PBO. Positive effects on "time to fall asleep" were reported by 72.8% (LEM5) and 73.1% (LEM10) versus 46.1% with PBO (<0.0001), and 58.0% (LEM5) and 62.0% (LEM10) reported positive effects on sleep duration versus 39.9% with PBO (<0.0001). Subjects reporting positive effects on "time to fall asleep" had greater change from baseline (CFB; improvement) at 6 months in median sSOL (in minutes; LEM5= -26.8; LEM10= -32.1; PBO= -17.5; <0.01) versus those reporting negative effects (LEM5= -9.1; LEM10= -10.4; PBO= -8.6; LEM5 vs PBO, =0.52; LEM10 vs PBO, =0.69). For sTST (in minutes) at 6 months, mean CFB tended to be greater for subjects reporting positive (LEM5=81.2, LEM10=93.2, PBO=74.8; LEM5 vs PBO, =0.28; LEM10 vs PBO, =0.18) versus negative (LEM5=46.4, LEM10=35.0, PBO=38.6; LEM5 vs PBO, =0.44; LEM10 vs PBO, =0.52) effects, although this was not statistically significant.
Patient impressions of the effects of lemborexant were positive based on the PGI-I and reflected improvements in subjective sleep outcome measures, indicating that the brief PGI-I tool may be useful in clinical practice.
利用来美克星的一项临床研究数据，评估患者总体印象-失眠（PGI-I）问卷的应答情况。该问卷是一份简单的包含4个条目的问卷，用于评估患者对药物睡眠疗效的看法，这可能有助于从患者角度评估具有临床意义的变化。
E2006-G001-303研究是一项针对失眠症成年患者的为期12个月、（前6个月）有安慰剂对照的3期研究，将受试者按1:1:1随机分为来美克星5毫克组（LEM5；n = 316）、10毫克组（LEM10；n = 315）或安慰剂组（n = 318）。此处未展示第二个6个月的情况。PGI-I结果在事后分析中与患者报告的（主观）入睡潜伏期（sSOL）和总睡眠时间（sTST）相关。
在6个月时：67.3%（LEM5）和68.8%（LEM10）的受试者报告药物对其睡眠有积极作用，而安慰剂组为45.0%（两者均P < 0.0001）。72.8%（LEM5）和73.1%（LEM10）的受试者报告对“入睡时间”有积极作用，而安慰剂组为46.1%（P < 0.0001），58.0%（LEM5）和62.0%（LEM10）的受试者报告对睡眠时间有积极作用，而安慰剂组为39.9%（P < 0.0001）。报告对“入睡时间”有积极作用的受试者在6个月时的中位sSOL较基线的变化（CFB；改善情况）（以分钟计；LEM5 = -26.8；LEM10 = -32.1；安慰剂 = -17.5；P < 0.01）大于报告有消极作用的受试者（LEM5 = -9.1；LEM10 = -10.4；安慰剂 = -8.6；LEM5与安慰剂相比，P = 0.52；LEM10与安慰剂相比，P = 0.69）。对于6个月时的sTST（以分钟计），报告有积极作用（LEM5 = 81.2，LEM10 = 93.2，安慰剂 = 74.8；LEM5与安慰剂相比，P = 0.28；LEM10与安慰剂相比，P = 0.18）的受试者的平均CFB往往大于报告有消极作用（LEM5 = 46.4，LEM10 = 35.0，安慰剂 = 38.6；LEM5与安慰剂相比，P = 0.44；LEM10与安慰剂相比，P = 0.52）的受试者，尽管这无统计学意义。
基于PGI-I，患者对来美克星疗效的印象是积极的，且反映出主观睡眠结果指标有所改善，表明简短的PGI-I工具在临床实践中可能有用。
