Pitolisant for Residual Excessive Daytime Sleepiness in OSA Patients Adhering to CPAP - Neuropsychiatrie- Recherche épidémiologique et clinique (U1061) Access content directly
Journal Articles Chest Year : 2021

Pitolisant for Residual Excessive Daytime Sleepiness in OSA Patients Adhering to CPAP

Johan Verbraecken
Jeanne-Marie Lecomte
  • Function : Author
Jean-Charles Schwartz
  • Function : Author
Patrice Bourgin
Marie D’ortho
  • Function : Contributor
Frederic Gagnadoux
Jean Claude Meurice
  • Function : Contributor
Xuan Lan Nguyen
  • Function : Contributor
Katrien Hertegonne
  • Function : Contributor
Daniel Rodenstein
  • Function : Contributor
Jan Ovesen
  • Function : Contributor
Soren Berg
  • Function : Contributor
Olli Polo
  • Function : Contributor
Tarja Saaresranta
  • Function : Contributor
Jan Anders Hedner
  • Function : Contributor
Yuksel Peker
  • Function : Contributor
W.J. Randerath
  • Function : Contributor
Elke Rössner
  • Function : Contributor
Diego Garcia Borreguero
  • Function : Contributor
Francisco Javier Puertas Cuesta
  • Function : Contributor
Joaquim Duran-Cantolla
  • Function : Contributor
Ferran Barbe
  • Function : Contributor
Dra Odile Romero
  • Function : Contributor
Yavor Ivanov
  • Function : Contributor
Hristo Metev
  • Function : Contributor
Diana Petkova
  • Function : Contributor
Merita Ismajli Marku
  • Function : Contributor

Abstract

Background: Excessive daytime sleepiness (EDS) in individuals with OSA syndrome persisting despite good adherence to CPAP is a disabling condition. Pitolisant is a selective histamine H3-receptor antagonist with wake-promoting effects.Research question: Is pitolisant effective and safe for reducing daytime sleepiness in individuals with moderate to severe OSA adhering to CPAP treatment but experiencing residual EDS?Study design and methods: In a multicenter, double-blind, randomized (3:1), placebo-controlled, parallel-design trial, pitolisant was titrated individually at up to 20 mg/day and taken over 12 weeks. The primary end point was change in the Epworth Sleepiness Scale (ESS) score in the intention-to-treat population. 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.Results: Two hundred forty-four 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). Adverse event occurrence (mainly headache and insomnia) was higher in the pitolisant group compared with the placebo group (47.0% and 32.8%, respectively; P = .03). No cardiovascular or other significant safety concerns were reported.Interpretation: Pitolisant used as adjunct to CPAP therapy for OSA with residual sleepiness despite good CPAP adherence significantly reduced subjective and objective sleepiness and improved participant-reported outcomes and physician-reported disease severity.
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Dates and versions

hal-03270752 , version 1 (24-04-2023)

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Attribution - NonCommercial

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Jean-Louis Pépin, Ognian Georgiev, Rumen Tiholov, Valérie Attali, Johan Verbraecken, et al.. Pitolisant for Residual Excessive Daytime Sleepiness in OSA Patients Adhering to CPAP. Chest, 2021, 159 (4), pp.1598-1609. ⟨10.1016/j.chest.2020.09.281⟩. ⟨hal-03270752⟩
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