TY - JOUR T1 - Pitolisant long term effect in sleepy obstructive sleep apnea patients without CPAP JF - ERJ Open Research JO - erjor DO - 10.1183/23120541.sleepandbreathing-2021.38 VL - 7 IS - suppl 7 SP - 38 AU - Y Dauvilliers AU - C CAUSSE AU - J Verbraecken AU - M Partinen AU - J Hedner AU - T Saaresranta AU - O Georgev AU - R Tiholov AU - I Lecomte AU - R Tamisier AU - P Levy AU - J Lecomte AU - J Schwartz AU - J Pépin Y1 - 2021/04/16 UR - http://openres.ersjournals.com/content/7/suppl_7/38.abstract N2 - Introduction: Pitolisant is a histamine H3-receptor antagonist/inverse agonist waking agent reducing sleepiness in narcolepsy.Objectives: HAROSA2 1 year study evaluated Pitolisant 20mg/d (P) efficacy and safety on excessive daytime sleepiness (EDS) in moderate to severe obstructive sleep apnea patients (OSA) refusing CPAP.Methods: 2 periods were defined in HAROSA2: a 12 weeks double blind period (DB) comparing P vs placebo (pl) (n=268) and then was proposed a 40 weeks open label period (OL) with P (n=236). The primary criteria was the Epworth sleep scale (ESS) change and the main secondary critria were sleep latency OSleR test (OSL), Pichot fatigue score (PF) and safety.Results: After 1 year, in patients with P during DB, we observed an additional ESS reduction -1.6 ± 3.4, an increase of OSL and an improvement of PF -1.4 ± 5.9 during OL. In patients with pl during DB and P during PO, we observed an ESS reduction -5.2 ± 5.4, an increase of sleep latency and improvement of PF-2.9 ± 6.2. Most frequent side effects were headaches, insomnia, nausea, vertigo without cardiovascular impact observed.Conclusion: After 1 year, OSA patients without CPAP presenting EDS treated with Pitolisant during DB were improved during OL on ESS, OSL and PF: Pitolisant efficacy was maintained during 1 year. OSA Patients without CPAP presenting EDS with placebo during DB, then treated with Pitolisant (OL) were improved with a similar ESS reduction. Pitolisant showed a favourable benefit risk balance to manage EDSr in OSA patients refusing of not tolerating CPAP.FootnotesCite this article as ERJ Open Research 2021; 7: Suppl. 7, 38.This is an ERS Lung Science Conference abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only). ER -