CNS drugs · 2025
Efficacy and Safety of Solriamfetol on Excessive Daytime Sleepiness Associated with Obstructive Sleep Apnea in China: A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Cheng Hanrong, Deng Liying, Meng Zili, Zhang Wei, Chen Tao, Chen Rui, Tang Shiyou, Lv Yunhui, Su Xiaoli, Liu Zhifen, Zhang Xiaoqing, Wang Xueyi, Mao Hongjing, Zhang Nuofu, Yu Huan, Pan Jiyang, Xie Yuping, Tang Jiyou, Yin Shankai, Wang Zan, Tong Maoqing, Zhan Shuqin, Wang Chunxue, Wang Bei, Zhang Weihua, Mi Weifeng, Lu Lin
Аннотация
BACKGROUND AND OBJECTIVES: Excessive daytime sleepiness (EDS) is a prominent symptom of obstructive sleep apnea (OSA), negatively affecting patients' quality of life. The objective of this study was to assess the efficacy and safety of solriamfetol in patients with OSA with EDS from China.
METHODS: This multicenter, randomized, double-blind, placebo-controlled phase 3 trial compared solriamfetol (75/150 mg once daily) with placebo for 12 weeks. Adults diagnosed with OSA, mean Maintenance of Wakefulness Test (MWT) sleep latency < 30 min, and Epworth Sleepiness Scale (ESS) score ≥ 10 were included. Patients with disorders causing EDS other than OSA were excluded. Co-primary endpoints were change from baseline to week 12 in MWT mean sleep latency and ESS score; a key secondary endpoint was improvement on Patient Global Impression of Change (PGI-C), assessed on a seven-point scale. MWT was performed at baseline and at weeks 2, 5, and 12, whereas the ESS and PGI-C were evaluated at weeks 2, 5, 8, and 12. Safety and tolerability were assessed on the basis of treatment-emergent adverse events (TEAEs), laboratory tests, vital signs, 24-h ambulatory blood pressure monitoring, 12-lead electrocardiogram, and physical examination. Statistical analyses of co-primary endpoints were performed on the full analysis set (FAS) using a mixed model for repeated measures (MMRM). Safety analyses were performed on the safety population. A hierarchical testing sequence was used to control multiplicity.
RESULTS: Of the 204 patients randomized (1:1) into placebo and solriamfetol groups, 192 completed the study (96 in each group). Co-primary endpoints were met, with significantly increased mean MWT sleep latency (P < 0.0001) and decreased ESS score (P = 0.0017) in the solriamfetol group (MWT, n = 95; ESS, n = 97) versus placebo (MWT, n = 95; ESS, n = 96) at week 12. Higher proportion of participants receiving solriamfetol (n = 90; 89.1%) reported improvement in PGI-C versus placebo (n = 77; 77.0%; P = 0.0221). At least one TEAE was reported in solriamfetol (n = 84; 82.4%) and placebo (n = 67; 65.7%) groups. The occurrence of serious TEAEs was low, with one incidence in both groups. Most frequently reported TEAEs in solriamfetol group included upper respiratory tract infection, dizziness, hyperuricemia, hypertension, hyperlipidemia, hypertriglyceridemia, and increased blood creatine phosphokinase. Most TEAEs were of mild/moderate severity and did not lead to study treatment discontinuation.
CONCLUSIONS: Solriamfetol demonstrated substantial efficacy and acceptable safety in Chinese patients with OSA with EDS, reinforcing its role as a viable treatment option.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT06103825.
METHODS: This multicenter, randomized, double-blind, placebo-controlled phase 3 trial compared solriamfetol (75/150 mg once daily) with placebo for 12 weeks. Adults diagnosed with OSA, mean Maintenance of Wakefulness Test (MWT) sleep latency < 30 min, and Epworth Sleepiness Scale (ESS) score ≥ 10 were included. Patients with disorders causing EDS other than OSA were excluded. Co-primary endpoints were change from baseline to week 12 in MWT mean sleep latency and ESS score; a key secondary endpoint was improvement on Patient Global Impression of Change (PGI-C), assessed on a seven-point scale. MWT was performed at baseline and at weeks 2, 5, and 12, whereas the ESS and PGI-C were evaluated at weeks 2, 5, 8, and 12. Safety and tolerability were assessed on the basis of treatment-emergent adverse events (TEAEs), laboratory tests, vital signs, 24-h ambulatory blood pressure monitoring, 12-lead electrocardiogram, and physical examination. Statistical analyses of co-primary endpoints were performed on the full analysis set (FAS) using a mixed model for repeated measures (MMRM). Safety analyses were performed on the safety population. A hierarchical testing sequence was used to control multiplicity.
RESULTS: Of the 204 patients randomized (1:1) into placebo and solriamfetol groups, 192 completed the study (96 in each group). Co-primary endpoints were met, with significantly increased mean MWT sleep latency (P < 0.0001) and decreased ESS score (P = 0.0017) in the solriamfetol group (MWT, n = 95; ESS, n = 97) versus placebo (MWT, n = 95; ESS, n = 96) at week 12. Higher proportion of participants receiving solriamfetol (n = 90; 89.1%) reported improvement in PGI-C versus placebo (n = 77; 77.0%; P = 0.0221). At least one TEAE was reported in solriamfetol (n = 84; 82.4%) and placebo (n = 67; 65.7%) groups. The occurrence of serious TEAEs was low, with one incidence in both groups. Most frequently reported TEAEs in solriamfetol group included upper respiratory tract infection, dizziness, hyperuricemia, hypertension, hyperlipidemia, hypertriglyceridemia, and increased blood creatine phosphokinase. Most TEAEs were of mild/moderate severity and did not lead to study treatment discontinuation.
CONCLUSIONS: Solriamfetol demonstrated substantial efficacy and acceptable safety in Chinese patients with OSA with EDS, reinforcing its role as a viable treatment option.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT06103825.