Randomized Controlled Trial of Solriamfetol for Excessive Daytime Sleepiness in OSA An Analysis of Subgroups Adherent or Nonadherent to OSA Treatment

被引:25
作者
Schweitzer, Paula K. [1 ]
Mayer, Geert [2 ]
Rosenberg, Russell [3 ,4 ]
Malhotra, Atul [5 ]
Zammit, Gary K. [6 ,7 ]
Gotfried, Mark [8 ]
Chandler, Patricia [9 ]
Baladi, Michelle [9 ]
Strohl, Kingman P. [10 ]
机构
[1] St Lukes Hosp, Sleep Med & Res Ctr, Chesterfield, MO 63017 USA
[2] Hephata Klin, Dept Neurol, Schwalmstadt, Germany
[3] NeuroTrials Res, Atlanta, GA USA
[4] Atlanta Sch Sleep Med, Atlanta, GA USA
[5] Univ Calif San Diego, Dept Pulm Crit Care & Sleep Med, San Diego, CA 92103 USA
[6] Clinilabs Drug Dev Corp, New York, NY USA
[7] Icahn Sch Med Mt Sinai, New York, NY 10029 USA
[8] Pulm Associates, Phoenix, AZ USA
[9] Jazz Pharmaceut, Palo Alto, CA USA
[10] Case Western Reserve Univ, Dept Physiol & Biophys, Cleveland, OH 44106 USA
基金
美国国家卫生研究院;
关键词
JZP-110; obstructive sleep apnea syndromes; sleep apnea; QUALITY-OF-LIFE; POSITIVE AIRWAY PRESSURE; CPAP USE; APNEA PATIENTS; PREVALENCE; MAINTENANCE; THERAPY; HEALTH;
D O I
10.1016/j.chest.2021.02.033
中图分类号
R4 [临床医学];
学科分类号
1002 ; 100602 ;
摘要
BACKGROUND: Solriamfetol, a dopamine-norepinephrine reuptake inhibitor, is approved in the United States to improve wakefulness in adults with excessive daytime sleepiness (EDS) associated with OSA (37.5-150 mg/d). RESEARCH QUESTION: Does solriamfetol have differential effects on EDS based on adherence to primary OSA therapy and does solriamfetol affect primary OSA therapy use? STUDY DESIGN AND METHODS: Participants were randomized to 12 weeks of placebo or solriamfetol 37.5, 75, 150, or 300 mg/d (stratified by primary OSA therapy adherence). Coprimary end points were week 12 change from baseline in 40-min Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS) in the modified intention-to-treat population. Primary OSA therapy use (hours per night, % nights) and safety were evaluated. RESULTS: At baseline, 324 participants (70.6%) adhered to OSA therapy (positive airway pressure use >= 4 h/night on >= 70% nights, surgical intervention, or oral appliance use on >= 70% nights) and 135 participants (29.4%) did not adhere. Least squares (LS) mean differences from placebo in MWT sleep latency (minutes) in the 37.5-, 75-, 150-, and 300-mg/d groups among adherent participants were 4.8 (95% CI, 0.6-9.0), 8.4 (95% CI, 4.3-12.5), 10.2 (95% CI, 6.8-13.6), and 12.5 (95% CI, 9.0-15.9) and among nonadherent participants were 3.7 (95% CI, -2.0 to 9.4), 9.9 (95% CI, 4.4-15.4), 11.9 (95% CI, 7.5-16.3), and 13.5 (95% CI, 8.8-18.3). On ESS, LS mean differences from placebo in the 37.5-, 75-, 150-, and 300-mg/d groups among adherent participants were -2.4 (95% CI, -4.2 to -0.5), -1.3 (95% CI, -3.1 to 0.5), -4.2 (95% CI, -5.7 to -2.7), and -4.7 (95% CI, -6.1 to -3.2) and among nonadherent participants were -0.7 (95% CI, -3.5 to 2.1), -2.6 (95% CI, -5.4 to 0.1), -5.0 (95% CI, -7.2 to -2.9), and -4.6 (95% CI, -7.0 to -2.3). Common adverse events included headache, nausea, anxiety, decreased appetite, nasopharyngitis, and diarrhea. No clinically meaningful changes were seen in primary OSA therapy use with solriamfetol. INTERPRETATION: Solriamfetol improved EDS in OSA regardless of primary OSA therapy adherence. Primary OSA therapy use was unaffected with solriamfetol.
引用
收藏
页码:307 / 318
页数:12
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