PASS to evaluate cardiovascular events in adult patients with obstructive sleep apnoe (OSA) treated with solriamfetol
Description
- Obstructive sleep apnea (OSA) is characterized by sleep fragmentation due to short-term oxygen deprivation caused by upper airway obstruction. A major symptom of OSA is excessive daytime sleepiness, which affects 10% of men and 3% of women despite continuous positive airway pressure therapy (CPAP) or other therapies.
Excessive daytime sleepiness interferes with activities of daily living, leads to loss of productivity, cognitive impairment and an increased risk of accidents, depression and anxiety.
Solriamfetol, a selective norepinephrine-dopamine reuptake inhibitor (SNDRI), has been approved in Germany since May 15, 2020 for the treatment of excessive daytime sleepiness in OSA and narcolepsy. Adverse effects included psychiatric symptoms, nervous system disorders, gastrointestinal complaints and increases in blood pressure and heart rate.
Due to the inherent cardiovascular risk of OSA patients and the exclusion of patients with pre-existing cardiovascular conditions in the pivotal studies, the European Medicines Agency (EMA) requested a post-authorization safety study to assess the incidence of serious cardiovascular and psychiatric disorders in users of solriamfetol with OSA.
In addition to German data from GePaRD, this project is also being conducted with French insurance data. The final report will be submitted in Q4 2026.
Funding period
- Begin: June 2022
End: December 2026
Sponsor
- Pharmaceutical industry