Preventive Effects of Bosentan on the Systemic Cardiovascular Consequence of Sleep Apnea

Phase 2 Completed 19 enrolled University Hospital, Grenoble Actelion · collab Institut National de la Santé Et de la Recherche Médicale, France · collab

RandomizedCrossoverOpen-labelTreatment

Summary

The study will compared the effects of bosentan, an endothelin receptor antagonist, and nasal continuous positive airway pressure (nCPAP), obstructive sleep apnea current reference treatment, on diastolic blood pressure in untreated mildly hypertensive sleep apnea patients. The hypothesis is that blocking endothelin receptors with a drug will have the same systemic blood pressure lowering effect than nCPAP in sleep apnea patients.

Timeline

Start: 2007-12
Primary completion: 2012-01
Completion: 2012-01

Outcome

Missed primary endpoint

paper In intention-to-treat analysis, the mean difference in 24-h DBP measurements between treatments was -3.1 (-6.9/0.7) mm Hg (median, 25th/75th percentiles) (P = 0.101) with bosentan having a greater effect. PMID 26643404 ↗

Publications

Results Joyeux-Faure M, Jullian-Desayes I, Pepin JL, Cracowski JL, Baguet JP, Tamisier R, Levy P, Godin-Ribuot D, Launois SH. Comparison of continuous positive airway pressure and bosentan effect in mildly hypertensive patients with obstructive sleep apnoea: A randomized controlled pilot study. Respirology. 2016 Apr;21(3):546-52. doi: 10.1111/resp.12713. Epub 2015 Dec 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bosentan	Other / unclassified	62.5 mg	—