Abstract
Abstract Introduction In addition to analyzing treatment response by comparing change from baseline (CFB) between active treatment and placebo (PBO), it is also informative to evaluate the percent of patients with a given magnitude of response. This can help establish the expected degree of improvement for patients, thereby helping to determine treatment success. Methods SUNRISE-2 (NCT02952820; E2006-G000-303) was a randomized, double-blind, global phase 3 study of lemborexant (LEM) in adults (≥18y) with insomnia disorder. Subjects received PBO or LEM (5mg [LEM5]; 10mg [LEM10]) for 6mo. LEM subjects continued their original dose, while PBO subjects were rerandomized to LEM for another 6mo (not reported here). Responder profiles were constructed separately for patient-reported, sleep diary-based subjective sleep onset and sleep maintenance based on the cumulative proportion of subjects with CFBs in 10-minute increments for subjective sleep onset latency (sSOL) or subjective wake after sleep onset (sWASO), respectively. The proportion was based on number of subjects with baseline data (denominator) and data available at time of visit; study dropouts were considered nonresponders. Results Baseline values were similar (median sSOL [min]: PBO, 55.9; LEM5, 53.6; LEM10, 55.7; mean[SD] sWASO [min]: PBO, 132.5[80.2]; LEM5, 132.8[82.5]; LEM10, 136.8[87.4]). At 6mo, a higher percentage of subjects with CFB of ≥20min in sSOL was observed with LEM versus PBO (PBO, 30.4%; LEM5, 45.5%; LEM10, 44.9%). At 12mo, a similar percentage of responders with a ≥20min CFB in sSOL was observed for LEM (LEM5, 40.4%; LEM10, 43.3%). A higher percentage of subjects with a CFB in sWASO of ≥60min was observed for LEM versus PBO at 6mo (PBO, 24.2%; LEM5, 27.8%: LEM10, 30.2%); similar percentages were observed at 12mo with LEM (LEM5, 27.8%; LEM10, 27.7%). The majority of treatment-emergent adverse events were mild/moderate. Conclusion LEM treatment provided important levels of sustained efficacy over the long term. LEM was well tolerated. Support Eisai Inc.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.