Tetrahydrocannabinol:Cannabidiol Oromucosal Spray for Multiple Sclerosis-Related Resistant Spasticity in Daily Practice.
Vermersch et al.·European neurologyImpact 1.1
Klarer NutzenGRADENiedrig50 Zitate
Stichproben = 433 Pat.
Dauer3 months
EndpunktSpastik-Score
Verblindungn.a.
DesignKohortenstudie
Cannabinoidkombination
THC:CBD1:1
Applikationoromukosal
”Kernaussage
THC:CBD-Spray verbesserte MS-bedingte Spastizität und assoziierte Symptome signifikant nach 3 Monaten mit guter Verträglichkeit.
Zusammenfassung
MOVE-2 EU Real-World-Register, n=433 MS-Patienten mit therapieresistenter Spastik (mittlere Dauer 7,4 Jahre, 78,1% nutzten Baclofen), prospektive Beobachtung über 3 Monate mit THC:CBD-Oromukosalspray als Add-on-Therapie. Nach 1 Monat setzten 349 Patienten (Responder: ≥20% Spastik-Verbesserung) die Therapie fort, nach 3 Monaten 281 Patienten. Mittlere Dosierung: 6 Sprühstöße/Tag. Spastik-Scores und assoziierte Symptome (Spasmen, Fatigue, Schmerz, Schlafqualität, Blasenfunktion) signifikant verbessert, ebenso Aktivitäten des täglichen Lebens und Lebensqualität (EQ-5D VAS). Unerwünschte Ereignisse bei 10,4% der Patienten, keine schwerwiegend.
P
PopulationErwachsene mit multipler Sklerose und therapieresistenter Spastik, n=433 (55% weiblich), mittlere MSS-Dauer 7,4 Jahre
OutcomeSignifikante Verbesserung der Spastik-Scores und assoziierter Symptome (Spasmen, Fatigue, Schmerz, Schlafqualität, Blasendysfunktion) sowie Lebensqualität (EQ-5D VAS) nach 3 Monaten; unerwünschte Ereignisse bei 10,4% (keine schwerwiegenden)
Vertrauen in die Evidenz
Sehr niedrigNiedrigModeratHoch
Niedrig
Zweite von vier GRADE-Stufen, die Effektschätzung ist begrenzt verlässlich.
Background: Tetrahydrocannabinol:cannabidiol (THC:CBD) oromucosal spray (Sativex(R)) is an add-on therapy for moderate-to-severe multiple sclerosis (MS)-related drug-resistant spasticity (MSS).
Aim: The MOVE-2 EU study collected data from everyday clinical practice concerning the effectiveness and tolerability of THC:CBD.
Methods: This was an observational, prospective, multicentre, non-interventional study. Patients with resistant MSS prescribed add-on THC:CBD oromucosal spray according to approved labelling, were followed for 3 months. After 1 month, only responders (>/=20% improvement in spasticity) continued treatment. The main endpoints were the evolution of MSS and associated symptoms, quality of life (QoL) and tolerability.
Results: Four hundred and thirty three patients (55% female) were recruited (98% in Italy). The mean duration of MSS was 7.4 years and baclofen was used by 78.1% of participants. Three hundred and forty nine participants continued with THC:CBD oromucosal spray after 1 month, and 281 after 3 months. THC:CBD mean dosage was 6 sprays/day. MSS scores and spasticity-related symptoms (spasms, fatigue, pain, sleep quality and bladder dysfunction) were significantly improved by THC:CBD at 3 months, as were activities of daily living, and QoL (EQ-5D VAS). Adverse events, none of which were severe or serious, were reported by 10.4% of patients.
Conclusions: In everyday clinical practice, THC:CBD oromucosal spray provided symptomatic relief of MSS and related troublesome symptoms.