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Concurrent administration of serotonergic antidepressants and ozanimod in participants with relapsing multiple sclerosis from the open-label extension DAYBREAK trial
RT. Naismith, JA. Cohen, A. Bar-Or, G. Comi, KW. Selmaj, HP. Hartung, JK. Sheffield, A. Krakovich, D. Tatosian, CY. Cheng, J. Reardon, V. Khaychuk, JV. Riolo, D. Silva, BA. Cree
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu časopisecké články
Odkazy
PubMed
38130041
DOI
10.1177/13524585231216854
Knihovny.cz E-zdroje
- MeSH
- antidepresiva škodlivé účinky MeSH
- indany * MeSH
- inhibitory zpětného vychytávání serotoninu a noradrenalinu * škodlivé účinky MeSH
- lidé MeSH
- oxadiazoly * MeSH
- roztroušená skleróza * chemicky indukované MeSH
- selektivní inhibitory zpětného vychytávání serotoninu škodlivé účinky MeSH
- serotonin MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
BACKGROUND: Monoamine oxidase (MAO) inhibitors can interact with selective serotonin reuptake inhibitors (SSRIs)/serotonin-norepinephrine reuptake inhibitors (SNRIs). There is clinical interest surrounding use of ozanimod with SSRIs/SNRIs because the major metabolites of ozanimod are weak inhibitors of MAO-B in vitro. OBJECTIVE: To evaluate the incidence of treatment-emergent adverse events (TEAEs) potentially related to serotonin accumulation (SA) during concomitant ozanimod and SSRI/SNRI use by performing analyses of data from an open-label, oral ozanimod 0.92 mg trial (DAYBREAK; NCT02576717). METHODS: SA narrow (serotonin syndrome, neuroleptic malignant syndrome, and hyperthermia malignant) and broad (terms potentially associated with SA) MedDRA v24.0 searches were performed using TEAE data from participants with relapsing multiple sclerosis who entered DAYBREAK from phase 3 studies (cutoff February 1, 2022). Incidences of TEAEs matching terms from each search were stratified by SSRI/SNRI use. RESULTS: Of 2257 DAYBREAK participants, 274 (12.1%) used an SSRI/SNRI. No participants had TEAEs matching the SA narrow search terms. There was no significant difference in the percentage of participants with ⩾1 TEAE matching the SA broad search for those on versus off SSRIs/SNRIs (on: 12.4%, n = 34/274; off: 15.6%, n = 310/1982, nominal p = 0.1630). CONCLUSION: MedDRA searches showed no increase in TEAEs potentially associated with SA with concomitant SSRI/SNRI and ozanimod use.
Brain and Mind Centre The University of Sydney Sydney NSW Australia
Bristol Myers Squibb Princeton NJ USA
Center for Neurology Łódź Poland
Collegium Medicum Department of Neurology University of Warmia and Mazury in Olsztyn Olsztyn Poland
Department of Neurology Medical Faculty Heinrich Heine University Düsseldorf Düsseldorf Germany
Department of Neurology Medical University of Vienna Vienna Austria
Mellen Center for MS Treatment and Research Cleveland Clinic Cleveland OH USA
Palacký University Olomouc Olomouc Czech Republic
Vita Salute San Raffaele University and Casa di Cura Igea Milan Italy
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