Assessment of the effect of the dual orexin receptor antagonist daridorexant on various indices of disease severity in patients with mild to moderate obstructive sleep apnea.
Daridorexant
Dual orexin receptor antagonist
Nighttime respiration
Obstructive sleep apnea
Sleep
Journal
Sleep medicine
ISSN: 1878-5506
Titre abrégé: Sleep Med
Pays: Netherlands
ID NLM: 100898759
Informations de publication
Date de publication:
04 2022
04 2022
Historique:
received:
06
07
2021
revised:
19
10
2021
accepted:
22
11
2021
pubmed:
21
3
2022
medline:
19
4
2022
entrez:
20
3
2022
Statut:
ppublish
Résumé
The dual orexin receptor antagonist daridorexant did not impact nighttime respiratory function as assessed by the apnea/hypopnea index (AHI) and nocturnal oxygen saturation (SpO In this randomized, double-blind, placebo-controlled, two-period, crossover study, 50 mg daridorexant or placebo was administered every evening for 5 days to 28 patients with mild to moderate OSA. Treatment differences (daridorexant - placebo) were explored for indices of OSA severity including the number and duration of apneas and hypopneas, mean and lowest nocturnal SpO After repeated-dose daridorexant, more respiratory events were observed compared to placebo, ie., treatment difference of 16.4 events (90% confidence interval: -0.4, 33.2) which is explained by a longer total sleep time. However, no treatment difference was detected for the longest duration of apneas and hypopneas (1.5 s [-8.3, 11.2] and 8.2 s [-6.6, 23.0], respectively), and lowest SpO These results suggest safe use of daridorexant in patients with mild to moderate OSA. ClinicalTrials.gov NCT03765294. A study to investigate the effects of ACT-541468 on nighttime respiratory function in patients with mild to moderate obstructive sleep apnea. https://clinicaltrials.gov/ct2/show/NCT03765294.
Sections du résumé
BACKGROUND
The dual orexin receptor antagonist daridorexant did not impact nighttime respiratory function as assessed by the apnea/hypopnea index (AHI) and nocturnal oxygen saturation (SpO
METHODS
In this randomized, double-blind, placebo-controlled, two-period, crossover study, 50 mg daridorexant or placebo was administered every evening for 5 days to 28 patients with mild to moderate OSA. Treatment differences (daridorexant - placebo) were explored for indices of OSA severity including the number and duration of apneas and hypopneas, mean and lowest nocturnal SpO
RESULTS
After repeated-dose daridorexant, more respiratory events were observed compared to placebo, ie., treatment difference of 16.4 events (90% confidence interval: -0.4, 33.2) which is explained by a longer total sleep time. However, no treatment difference was detected for the longest duration of apneas and hypopneas (1.5 s [-8.3, 11.2] and 8.2 s [-6.6, 23.0], respectively), and lowest SpO
CONCLUSION
These results suggest safe use of daridorexant in patients with mild to moderate OSA.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov NCT03765294. A study to investigate the effects of ACT-541468 on nighttime respiratory function in patients with mild to moderate obstructive sleep apnea. https://clinicaltrials.gov/ct2/show/NCT03765294.
Identifiants
pubmed: 35306405
pii: S1389-9457(22)00039-9
doi: 10.1016/j.sleep.2021.11.015
pii:
doi:
Substances chimiques
Imidazoles
0
Orexin Receptor Antagonists
0
Pyrrolidines
0
daridorexant
0
Banques de données
ClinicalTrials.gov
['NCT03765294']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
4-11Informations de copyright
Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.