J. Pépin, C. Caussé, O. Georgev, R. Tiholov, V. Attali, J. Verbraecken, B. Buyse, M. Partinen, I. Fietze, G. Belev, D. Dokic, R. Tamisier, P. Lévy, I. Lecomte, J. Lecomte, J. Schwartz, Y. Dauvilliers
{"title":"Pitolisant long term effect in sleepy obstructive sleep apnea patients with CPAP","authors":"J. Pépin, C. Caussé, O. Georgev, R. Tiholov, V. Attali, J. Verbraecken, B. Buyse, M. Partinen, I. Fietze, G. Belev, D. Dokic, R. Tamisier, P. Lévy, I. Lecomte, J. Lecomte, J. Schwartz, Y. Dauvilliers","doi":"10.1183/23120541.SLEEPANDBREATHING-2021.37","DOIUrl":"https://doi.org/10.1183/23120541.SLEEPANDBREATHING-2021.37","url":null,"abstract":"Introduction: Pitolisant is a histamine H3-receptor antagonist/inverse agonist waking agent reducing sleepiness in narcolepsy. Objectives: HAROSA1 1 year study evaluated Pitolisant 20mg/d (P) efficacy and safety on residual excessive daytime sleepiness (rEDS) in obstructive sleep apnea patients (OSA) treated with CPAP with a good compliance. Methods: 2 periods were defined in HAROSA1: a 12 weeks double blind period (DB) comparing P vs placebo (pl) (n=244) and then was proposed a 40 weeks open label period (OL) with P (n=206). The primary criteria was the Epworth sleep scale (ESS) change and the main secondary criteria 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 -1.21 ± 3.12, an increase of OSL and an improvement of PF -1.6 ± 5.8 during OL. In patients with pl during DB and P during PO, we observed an ESS reduction -4.07 ± 5.29, an increase of sleep latency and improvement of PF-1.2 ± 5.8. Most frequent side effects were headaches, insomnia, nausea, vertigo without cardiovascular impact observed. Conclusion: After 1 year, OSA patients with CPAP and presenting rEDS treated with Pitolisant during DB were improved during OL on ESS, OSL and PF: Pitolisant efficacy was maintained during 1 year. OSA Patients with CPAP presenting rEDS 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 rEDS in OSA patients with CPAP.","PeriodicalId":201274,"journal":{"name":"Sleep & Breathing disorders","volume":"49 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125650443","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
E. Florou, A. Bonakis, K. Baou, H. Loutrari, A. Minaritzoglou, E. Vagiakis
{"title":"Treatment-emergent central sleep apnea","authors":"E. Florou, A. Bonakis, K. Baou, H. Loutrari, A. Minaritzoglou, E. Vagiakis","doi":"10.1183/23120541.SLEEPANDBREATHING-2021.64","DOIUrl":"https://doi.org/10.1183/23120541.SLEEPANDBREATHING-2021.64","url":null,"abstract":"Indroduction: Treatment-emergent central sleep apnea(complex sleep apnea) has been observed in approximately 3,5%-20% of patients treated with CPAP for obstructive sleep apnea Aims and objectives: To identify facrors that influence the evolution of treatment-emergent central sleep apnea Patients and methods: 40 patients diagnosed with treatment-emergent central sleep apnea in a general hospital were followed up using data from the CPAP memory cards and repeated clinical examinations.95% were men, with mean age:61±9.7 years, Body Mass Index:29.1±4.2 and polysomnography Apnea Hypopnea Index(AHI):60.9±27.2 Results: 2 to 6 months after the initiatin of treatment with CPAP 45.9% of patients had a residual AHIl5, whereas only 8% had residual AHIg15. There was a further resolution of treatment-emergent central sleep apnea after the initial 6 months of follow-up. Changes in the initial CPAP pressure settings were not found to be related to residual AHI improvement. Conclusions: Improvement in residual AHI of treatment-emergent central sleep apnea patients beyond the initial 6 months warrants further investigation.Changes in the initial CPAP pressure settings are not correlated to improved residual AHI","PeriodicalId":201274,"journal":{"name":"Sleep & Breathing disorders","volume":"113 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133187416","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
C. Caussé, J. Pépin, Y. Dauvilliers, V. Attali, P. Lehert
{"title":"Pitolisant efficacy in excessive daytime sleepiness for patients with obstructive sleep apnea","authors":"C. Caussé, J. Pépin, Y. Dauvilliers, V. Attali, P. Lehert","doi":"10.1183/23120541.SLEEPANDBREATHING-2021.16","DOIUrl":"https://doi.org/10.1183/23120541.SLEEPANDBREATHING-2021.16","url":null,"abstract":"Introduction: Pitolisant a Histamin H3-receptor inverse agonist waking agent for Excessive Daytime Sleepines (EDS) treatment in narcolepsy showed efficacy on EDS in Obstructive Sleep Apnea (OSA) patients with EDS treated respectively with and without Continuous Positive Airway Pressure (CPAP). Objective: Its efficacy and safety at 20mg/day was evaluated through an Individual patient data meta-analysis vs placebo.Methods: Epworth Sleep Scale (ESS) and Oxford Sleep Resistance (Osler) tests were co-primary endpoints tested at 0.025 significance and Fatigue (Pichot Scale) was secondary. Results: A significant mean ESS reduction of -3.06([95%CI -4.1,-2.02], Pl 0.001) was found with Pitolisant versus placebo and 81% more patients decreased final ESS to less than 10 (RR= 1.81 [95%CI 1.36, 2.39], pl 0.001). The Osler Final/Baseline was also 18% better (ratio=1.18[95%CI 1.02,1.35], P=0.022). A clinically meaningful EDS effect of Pitolisant measured by the aggregate Z-score on ESS and Osler was 0.71([0.46, 0.97], Pl 0.001). Finally, a significant mean Pichot Fatigue reduction of -1.23([-2.29,0.18], P=0.022) was found. These effects were shown invariant across various subgroups of the population (age,gender,work conditions). Finally these effects were not impacted as to whether or not CPAP was used. Side effect incidence was similar in both groups. Conclusions: These results confirm pitolisant efficacy on EDS and Fatigue symptoms in sleepy OSA patients versus placebo, evaluated by the ESS, Osler, EDS Z-score and Pichot Fatigue, irrespective of CPAP use. Bioprojet sponsored this analysis. CC is an employee of bioprojet pharma. JLP, YD, VA, were investigators, PL received honoraria from bioprojet.","PeriodicalId":201274,"journal":{"name":"Sleep & Breathing disorders","volume":"24 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134267698","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Lopes, Nuno Cortesão, I. Pinto, M. Dias, Isabel Teixeira
{"title":"Adherence predictors to positive airway pressure (PAP) treatment in patients with obstructive sleep apnea (OSA)","authors":"A. Lopes, Nuno Cortesão, I. Pinto, M. Dias, Isabel Teixeira","doi":"10.1183/13993003.congress-2020.1341","DOIUrl":"https://doi.org/10.1183/13993003.congress-2020.1341","url":null,"abstract":"Background: Adherence to PAP treatment is a mainstay in the management of patients (pts) with OSA, although this is often difficult to attain and to maintain in the long term. At our outpatient clinic each patient is evaluated along the time by a multidisciplinary team, being expected that this follow-up program will allow an improved adherence to PAP therapy. Methods: An observational and retrospective longitudinal study was conducted analyzing age, anthropometric, clinical, diagnostic and treatment-related variables over a predefined timeline (initial, 3, 6 and 12 months). Multilevel mixed-effects linear regression models were used to analyze data, and a significance level, α = 0.05, was used. Results: Were analyzed 133 pts. OSA severity was: Severe (70%); Moderate (22%); Mild (8%). Most prevalent PAP mode was Auto-CPAP (86%), with nasal mask (65%) and the most frequent prescribed pressures were 4-12 cmH2O. PAP usage ≥ 90% of total time / usage ≥ 4h/night was 66%/70%, 69%/81%, 71%/90% and 69%/88%, at initial, 3, 6 and 12 M, respectively. The usage ≥ 4h/night had an increasing trend with the time of therapy (p l0.001, comparing initial with 3M, 6M and 12M). AIH and Epworth scale have been significantly improved to normal values (p l0.001). The most frequent complications were excessive leakage, nasal obstruction, excessive pressure and dry mouth. Multivariate analysis showed that higher adherence values (usage ≥ 4h/night) are associated with older ages, higher oxygen dessaturation index and absence of complications (p≤0.001). Conclusion: Our program has a good performance regarding treatment efficacy, with a low prevalence of complications and improved in-night adherence.","PeriodicalId":201274,"journal":{"name":"Sleep & Breathing disorders","volume":"30 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114357623","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}