Pitolisant is a histamine H3 receptor antagonist with a wake-promoting effect that is used in narcolepsy treatment. Daytime sleepiness and fatigue are common complaints among patients with obstructive sleep apnea (OSA). Although continuous positive airway pressure (CPAP) is the main treatment for OSA, low adherence, and refusal are common. A trial by Dauvilliers et al. published on May 1, 2020 edition of AJRCCM performed in 10 European countries evaluates the efficacy of Pitolisant on daytime sleepiness among patients with OSA who refused CPAP.
This study is a phase III, double-blind, randomized, placebo-controlled, parallel-group trial including 268 patients with moderate-severe OSA who refused CPAP treatment. In the pitolisant group, the medication was titrated up to 20 mg/d over 12 weeks. Compared to placebo, pitolisant significantly decreased ESS (-2.8; CI -4.0 to -1.5; p < 0.001) and Pichot fatigue score without significant difference in wake maintenance test, heart rate, or blood pressure between groups. The result support benefits for pitolisant treating sleepiness among patients with OSA, at least in the short term. Longer term effectiveness and adverse effects will need to be evaluated.
https://www.atsjournals.org/doi/abs/10.1164/rccm.201907-1284OC
(Post by: Pahnwat Tonya Taweesedt)