Treatment Regimen Improves Residual Excessive Daytime Sleepiness

Subjective and objective sleepiness were significantly reduced in patients with obstructive sleep apnea (OSA) after pitolisant was administered as adjunct to continuous positive airway pressure (CPAP) therapy, according to study findings.

Researchers conducted a multicenter, double-blind, randomized, placebo-controlled, parallel-design clinical trial in which participants were administered up to 20 mg/day of pitolisant over 12 weeks. Change in the Epwork Sleepiness Scale (ESS) score was measured as the primary endpoint.

“Key secondary end points were maintenance of wakefulness assessed by the Oxford Sleep Resistance Test, Clinical Global Impressions scale of severity, the patient's global opinion, EuroQoL quality of life questionnaire score, Pichot fatigue questionnaire score, and safety,” stated authors of the study.

According to study authors, 244 OSA participants (82.8% men; mean age, 53.1 years; mean Apnea Hypopnea Index with CPAP, 4.2/h; baseline ESS score, 14.7) were randomized to pitolisant (n=183) or placebo (n=61).

“ESS significantly decreased with pitolisant compared with placebo (-2.6; 95% CI, -3.9 to -1.4; P < .001), and the rate of responders to therapy (ESS ≤ 10 or change in ESS ≥ 3) was significantly higher with pitolisant (71.0% vs 54.1%; P = .013),” stated researchers.

Furthermore, adverse event occurrence such as headache and insomnia were higher in the pitolisant group compared with the placebo group (47.0% and 32.8%, respectively; P = .03), according to authors of the study; however, no cardiovascular or other significant safety concerns were reported.

Reference:
Pépin JL, Georgiev O, Tiholov R, et al. Pitolisant for residual excessive daytime sleepiness in OSA patients adhering to CPAP: a randomized trial. Chest. 2021;4(159):1598-1609. doi:10.1016/j.chest.2020.09.281.