PT  - JOURNAL ARTICLE
AU  - Dauvilliers, Yves
AU  - Verbraecken, Johan
AU  - Partinen, Markku
AU  - Hedner, Jan
AU  - Saaresranta, Tarja
AU  - Georgiev, Ognian
AU  - Tiholov, Rumen
AU  - Caussé, Christian
AU  - Lecomte, Isabelle
AU  - Tamisier, Renaud
AU  - Lévy, Patrick
AU  - Lecomte, Jeanne-Marie
AU  - Schwartz, Jean-Charles
AU  - Pépin, Jean-Louis
TI  - Pitolisant long term effect in sleepy obstructive sleep apnea patients without CPAP
AID  - 10.1183/13993003.congress-2021.PA745
DP  - 2021 Sep 05
TA  - European Respiratory Journal
PG  - PA745
VI  - 58
IP  - suppl 65
4099  - http://erj.ersjournals.com/content/58/suppl_65/PA745.short
4100  - http://erj.ersjournals.com/content/58/suppl_65/PA745.full
SO  - Eur Respir J2021 Sep 05; 58
AB  - Objectives: Pitolisant is a histamine H3-receptor antagonist/inverse agonist waking agent reducing sleepiness in narcolepsy. 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 a ESS reduction -5.2 ± 5.4, an increase of sleep latency and an 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: European Respiratory Journal 2021; 58: Suppl. 65, PA745.This abstract was presented at the 2021 ERS International Congress, in session “Prediction of exacerbations in patients with COPD”.This is an ERS International Congress 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).