Pitolisant reduces daytime sleepiness in OSA
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Treatment with pitolisant, as compared with placebo, reduced excessive daytime sleepiness and improved several other outcomes among patients with obstructive sleep apnea who refuse CPAP, according to a study published in the American Journal of Respiratory and Critical Care.
Specifically, from baseline to 12 weeks, the Epworth Sleepiness Scale (ESS) score decreased by 6.3 points among patients treated with pitolisant (Wakix, Harmony Biosciences) vs. 3.6 points among those who received placebo (P < .001). Overall, the primary analysis showed that the ESS score was reduced by 2.8 points more with pitolisant than with placebo (P < .001).
However, the ability to maintain wakefulness as measured by the Oxford Sleep Resistance test — a key secondary outcome — was not significantly different between the pitolisant and placebo groups.
In terms of other secondary outcomes, the mean Pichot fatigue scale score decreased by 3.6 more points in the pitolisant group than in the placebo group (P = .005). Additionally, more patients in the pitolisant group than in the placebo group express improvements in Clinical Global Impression of Severity and Change (84.2% vs. 56.3%; P < .001) and Patient’s Global Opinion (86.3% vs. 60.9%; P < .001).
The researchers also observed nonsignificant trends toward improvement with pitolisant vs. placebo in responder rates according to the ESS, sleep diary variables and the EuroQoL questionnaire. However, they found no significant differences between groups in the mean time to perform the Trail Making Tests A and B or in items on the Leeds Sleep Evaluation Questionnaire with the exception of behavior after waking with pitolisant.
The frequency of treatment-emergent adverse events did not differ significantly between the pitolisant and placebo groups (29.5% vs. 25.4%), with headaches, insomnia, nausea and vertigo as the most commonly reported events. There were no cardiovascular or other significant safety concerns, according to the data.
“Pitolisant reduced self-reported excessive daytime sleepiness as measured by the ESS
along with an overall improvement in both patient-reported outcomes and physician assessed severity in adult OSA patients refusing CPAP with daytime sleepiness,” the researchers wrote.
The international, multicenter, double-blind, placebo-controlled, parallel-design trial included patients randomly assigned in a 3:1 fashion to pitolisant titrated up to 20 mg per day over 12 weeks or placebo. A total of 268 patients with OSA who refused or were not adhering to CPAP therapy with a baseline apnea-hypopnea index of 49 events per hour and a baseline sleepiness score of 15.7 were included in the in analysis. – by Melissa Foster
Disclosures: This study was funded by Bioprojet. Dauvilliers reports he has received grants from Bioprojet, Harmony Bioscience, Idorsia, Jazz Pharmaceuticals, Takeda, Theranexus and UCB. Please see the study for all other authors’ relevant financial disclosures.