講師資料
Talks：
Pitolisant studies on Narcolepsy and Obstructive Sleep Apnea (OSA)
Name：
Dr. Christian CAUSSÉ
Position：
Medical Affairs Director
Affiliation：
Bioprojet Pharma
Email：
Photo：
Research Interests：
Sleep disorders, narcolepsy, Obstructive Sleep Anea
Selected Publications：
1. Dauvilliers, Yves et al. “Safety and efficacy of pitolisant in children aged 6 years or older with narcolepsy with or without cataplexy: a double-blind, randomised, placebo-controlled trial.” The Lancet. Neurology vol. 22,4 (2023): 303-311. doi:10.1016/S1474-4422(23)00036-4
2. Pépin, Jean-Louis et al. “Long-Term Efficacy and Safety of Pitolisant for Residual Sleepiness Due to OSA.” Chest vol. 165,3 (2024): 692-703. doi:10.1016/j.chest.2023.11.017
3. Craig, Sonya et al. “Investigation and management of residual sleepiness in CPAP-treated patients with obstructive sleep apnoea: the European view.” European respiratory review : an official journal of the European Respiratory Society vol. 31,164 210230. 25 May. 2022, doi:10.1183/16000617.0230-2021
Abstract：
Introduction
Obstructive sleep apnoea (OSA) is a common chronic respiratory disease associated with a high burden of disabilities related to sleepiness and reduced quality of life. Despite first-line treatment with continuous positive airway pressure (CPAP) therapy, many patients experience residual EDS. Pharmacological treatment options authorised in Europe and/or the United States are modafinil/armodafinil, solriamfetol, and pitolisant. In the absence of head-to-head trials, the relative efficacy and safety of these agents is largely unknown.
Methods
Randomised controlled trials (RCTs) that compared the efficacy and safety of authorised medications for OSA were analysed using network meta-analysis. The primary efficacy endpoint was combined Epworth Sleepiness Scale (ESS) and Oxford Sleep Resistance (OSLER)/Maintenance of Wakefulness Test (MWT) Z-scores. Quality of life (QoL), overall and cardiovascular safety, and benefit-risk ratios were calculated.
Results
Of 4017 studies identified, a total of 20 RCTs involving 4015subjects were included. Analysis of combined subjective (ESS) and objective (OSLER/MWT) efficacy outcome Z-scores showed that solriamfetol (150 mg; effect size [ES]=0.66 [95% CI: 0.36, 0.96]), and pitolisant (20 mg; ES=0.66 [95% CI: 0.44, 0.88]), modafinil (200 mg; ES=0.53 :[95% CI: 0.33, 0.73]); 400 mg; ES=0.53 [95% CI: 0.42, 0.64]) had a clinically meaningful improvement in efficacy. P-scores ranked placebo, then pitolisant, modafinil 200 mg, modafinil 400 mg and solriamfetol for overall safety; and pitolisant, then solriamfetol, modafinil 400 mg and modafinil 200 mg for benefit-risk ratio.
Conclusion
Pitolisant, solriamfetol and modafinil had comparable efficacy for maintaining wakefulness in patients with OSA. Pitolisant had a better safety profile and benefit-risk ratio compared with solriamfetol and modafinil. The overall and cardiovascular safety risk ratios suggest that pitolisant might be the best candidate for OSA patients with multiple cardiovascular comorbidities.
2024年會：
10/13 11:00 Pitolisant studies on Narcolepsy and Obstructive Sleep Apnea (OSA) [會議室2]
10/13 11:40 QA Discussion [會議室2]
10/13 12:20 QA Discussion [會議室2]