Randomized Controlled Trial of Solriamfetol for Excessive Daytime Sleepiness in OSA

Schweitzer, Paula K.; Mayer, Geert; Rosenberg, Russell; Malhotra, Atul; Zammit, Gary; Gotfried, Mark H.; Chandler, Patricia; Baladi, Michelle G.

doi:10.1016/j.chest.2021.02.033

Cited by 21 publications

(10 citation statements)

References 36 publications

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“…As noted, EDS frequently accompanies OSA and appears to be associated with increased cardiovascular risk relative to non-sleepy patients with OSA;5 6 14 therefore, theoretically, treating sleepiness in patients with OSA may, independent of PAP therapy, reduce cardiovascular risk. In a recent clinical trial, Schweitzer et al 50 found 12 weeks of solriamfetol use reduced sleepiness independent of PAP adherence. While this could conceivably reduce cardiovascular risk in patients with OSA, longitudinal studies examining hard clinical outcomes (e.g., MACE) are needed to support this claim.…”

Section: Future Directionsmentioning

confidence: 99%

Excessive daytime sleepiness: an emerging marker of cardiovascular risk

Bock

Covassin

Somers

2022

Heart

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Excessive daytime sleepiness (EDS) is classically viewed as a consequence of insufficient sleep or a symptom of sleep disorders. Epidemiological and clinical evidence have shown that patients reporting EDS in tandem with sleep disorders (e.g., obstructive sleep apnoea) are at greater cardiovascular risk than non-sleepy patients. While this may simply be attributable to EDS being present in patients with a more severe condition, treatment of sleep disorders does not consistently alleviate EDS, indicating potential aetiological differences. Moreover, not all patients with sleep disorders report EDS, and daytime sleepiness may be present even in the absence of any identifiable sleep disorder; thus, EDS could represent an independent pathophysiology. The purpose of this review is twofold: first, to highlight evidence that EDS increases cardiovascular risk in the presence of sleep disorders such as obstructive sleep apnoea, narcolepsy and idiopathic hypersomnia and second, to propose the notion that EDS may also increase cardiovascular risk in the absence of known sleep disorders, as supported by some epidemiological and observational data. We further highlight preliminary evidence suggesting systemic inflammation, which could be attributable to dysfunction of the gut microbiome and adipose tissue, as well as deleterious epigenetic changes, may promote EDS while also increasing cardiovascular risk; however, these pathways may be reciprocal and/or circumstantial. Additionally, gaps within the literature are noted followed by directions for future research.

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Section: Future Directionsmentioning

confidence: 99%

Excessive daytime sleepiness: an emerging marker of cardiovascular risk

Bock

Covassin

Somers

2022

Heart

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“…Dosierungen bis zu 150 mg Solriamfetol erwiesen sich als angemessen, um die exzessive Tagesschläfrigkeit effektiv zu behandeln [ 38 ]. Solriamfetol wirkt bei Patienten, die Positivdrucktherapie ausreichend oder zu wenig nutzen, ähnlich effektiv [ 39 , 40 ]. Solriamfetol hatte wiederum keinen Effekt auf die Dauer der Nutzung der Positivdrucktherapie [ 39 , 40 ].…”

Section: Medikamentöse Therapieunclassified

“…Solriamfetol wirkt bei Patienten, die Positivdrucktherapie ausreichend oder zu wenig nutzen, ähnlich effektiv [ 39 , 40 ]. Solriamfetol hatte wiederum keinen Effekt auf die Dauer der Nutzung der Positivdrucktherapie [ 39 , 40 ].…”

Section: Medikamentöse Therapieunclassified

Schlafbezogene Atmungsstörungen – Update 2021

Arzt

2022

Somnologie

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Hintergrund Schlafbezogene Atmungsstörungen (SBAS) und andere Schlafstörungen sind sehr häufige Erkrankungen, die zu erheblichen Einbußen hinsichtlich der Lebensqualität, Arbeitsfähigkeit und Prognose beitragen können. Fragestellung Welche neuen Erkenntnisse gab es in der Schlaf- und Beatmungsmedizin zwischen November 2019 und Oktober 2021, die die Versorgung von Patienten mit SBAS maßgeblich beeinflussen? Material und Methoden Es wurde eine systematische Literaturrecherche im Zeitraum November 2019 bis Oktober 2021 und eine Auswahl der relevantesten Artikel durchgeführt. Ergebnisse Die für die Versorgung von Patienten mit SBAS relevantesten Ergebnisse waren: 1) Eine Therapie mit Continuous Positive Airway Pressure (CPAP) kann zwar bei Patienten mit SBAS den arteriellen Blutdruck senken, führt aber bei a‑ oder oligosymptomatischen Patienten und SBAS zu keiner Reduktion des Risikos für Myokardinfarkt oder Schlaganfall. 2) Nachdem in den letzten Jahren die Wirksamkeit der Unterkieferprotrusionsschienen (UKPS) bei ausgewählten Patienten mit obstruktiver Schlafapnoe (OSA) gezeigt wurde, sind UKPS seit 2021 als Secondline-Therapie nach CPAP auch erstattungsfähig. 3) Solriamfetol und Pitolisant wurden durch die Europäische Arzneimittelbehörde (EMA) für die Indikation der residualen Tagesschläfrigkeit bei Patienten mit OSA zugelassen. 4) Telemedizinische Verfahren können in der Langzeitbetreuung von Patienten mit SBAS hilfreich sein. Schlussfolgerungen Die diskutierten Studien liefern für die Versorgung von Patienten mit SBAS relevante Ergebnisse.

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“…Beyond mortality, quality of life and fitness to drive are altered in a subgroup of these patients. For these reasons, research was conducted to address efficacy of stimulants in this specific situation of untreated or nonadherent OSA [94,95]. In these studies, the range of efficacy for improving sleepiness was the same for adherent and nonadherent patients.…”

Section: History Of Treatments For Eds In Addition To Cpapmentioning

confidence: 99%

Investigation and management of residual sleepiness in CPAP-treated patients with obstructive sleep apnoea: the European view

et al. 2022

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Excessive daytime sleepiness (EDS) is a major symptom of obstructive sleep apnoea (OSA), defined as the inability to stay awake during the day. Its clinical descriptors remain elusive, and the pathogenesis is complex, with disorders such as insufficient sleep and depression commonly associated. Subjective EDS can be evaluated using the Epworth Sleepiness Scale, in which the patient reports the probability of dozing in certain situations; however, its reliability has been challenged. Objective tests such as the multiple sleep latency test or the maintenance of wakefulness test are not commonly used in patients with OSA, since they require nocturnal polysomnography, daytime testing and are expensive. Drugs for EDS are available in the United States but were discontinued in Europe some time ago. For European respiratory physicians, treatment of EDS with medication is new and they may lack experience in pharmacological treatment of EDS, while novel wake-promoting drugs have been recently developed and approved for clinical use in OSA patients in the USA and Europe. This review will discuss 1) the potential prognostic significance of EDS in OSA patients at diagnosis, 2) the prevalence and predictors of residual EDS in treated OSA patients, and 3) the evolution of therapy for EDS specifically for Europe.

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Randomized Controlled Trial of Solriamfetol for Excessive Daytime Sleepiness in OSA

Cited by 21 publications

References 36 publications

Excessive daytime sleepiness: an emerging marker of cardiovascular risk

Excessive daytime sleepiness: an emerging marker of cardiovascular risk

Schlafbezogene Atmungsstörungen – Update 2021

Investigation and management of residual sleepiness in CPAP-treated patients with obstructive sleep apnoea: the European view

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