Yves Dauvilliers, Johan Verbraecken , Markku Partinen et al
AJRCCM 2020 201 (9) doi.org/10.1164/rccm.201907-1284OC
The aim of this study was to evaluate the efficacy and safety of pitolisant, a selective histamine H3 receptor antagonist with wake-promoting effects, for the treatment of daytime sleepiness in patients with moderate to severe obstructive sleep apnea refusing continuous positive airway pressure treatment.
268 patients with obstructive sleep apnea (75% male; mean age, 52 yr; apnea–hypopnea index, 49/h; baseline sleepiness score, 15.7) were randomized (200 to pitolisant and 68 to placebo) and analyzed on an intention-to-treat basis. The Epworth Sleepiness Scale score was reduced more with pitolisant than with placebo (−2.8; 95% confidence interval, −4.0 to −1.5; P < 0.001). Wake maintenance tests were not improved. The Pichot fatigue score was reduced with pitolisant.
The authors conclude that Pitolisant significantly reduced self-reported daytime sleepiness and fatigue and improved patient-reported outcomes and physician disease severity assessment in sleepy patients with obstructive sleep apnea refusing or nonadherent to continuous positive airway pressure.