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%, = 34/274; off: 15.6%, = 310/1982, nominal = 0.1630).
Conclusion: MedDRA searches showed no increase in TEAEs potentially associated with SA with concomitant SSRI/SNRI and ozanimod use.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10851643 | PMC |
| http://dx.doi.org/10.1177/13524585231216854 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Risk factors of short-term poor functional outcomes and long-term durability of ruptured large or giant intracranial aneurysms.
J Neurosurg
January 2025
13Department of Neurosurgery, Shimane Prefectural Central Hospital, Shimane, Japan.
Objective: Aneurysmal subarachnoid hemorrhage (SAH) is associated with high morbidity and mortality rates. In particular, functional outcomes of SAH caused by large or giant (≥ 10 mm) ruptured intracranial aneurysms are worsened by high procedure-related complication rates. However, studies describing the risk factors for poor functional outcomes specific to ruptured large/giant aneurysms are sparse.
View Article and Find Full Text PDFDonor Regulatory T-Cell Therapy to Prevent Graft-Versus-Host Disease.
Blood
January 2025
Stanford University Medical Center, Stanford, California, United States.
Allogeneic hematopoietic cell transplantation (HCT) is a curative therapy limited by graft-versus-host disease (GVHD). In preclinical studies and early-phase clinical studies enrichment of donor regulatory T cells (Tregs) appears to prevent GVHD and promote healthy immunity.We enrolled 44 patients on an open-label, single-center, phase 2 efficacy study investigating if a precision selected and highly purified Treg cell therapy manufactured from donor mobilized peripheral blood improves one-year GVHD-free relapse free survival (GRFS) after myeloablative conditioning (trial NCT01660607).
View Article and Find Full Text PDFSafety, Efficacy and Pharmacokinetics of daily optimised doses of Rifampicin for the Treatment of Tuberculosis: A Systematic Review and Bayesian Network Meta-Analysis.
Clin Infect Dis
January 2025
EPIUnit - Instituto de Saúde Pública, Universidade do Porto, Porto, Portugal.
Background: Higher than standard doses of rifampicin could improve the treatment outcome of drug-susceptible tuberculosis without compromising the safety of patients.
Methods: We performed a systematic review of prospective clinical studies including adults with pulmonary and extrapulmonary TB receiving rifampicin doses above 10mg/kg/day. We extracted the data on overall adverse events (AE), hepatic AE, sputum culture conversion (SCC) at week 8, recurrence, mortality, and pharmacokinetics.
Do you know your PSMA-tracer? Variability in the biodistribution of different PSMA ligands and its potential impact on defining PSMA-positivity prior to PSMA-targeted therapy.
EJNMMI Res
January 2025
Department of Nuclear Medicine, University Hospital of Cologne, Kerpener Straße 62, 50937, Cologne, Germany.
Background: In clinical practice, several radiopharmaceuticals are used for PSMA-PET imaging, each with distinct biodistribution patterns. This may impact treatment decisions and outcomes, as eligibility for PSMA-directed radioligand therapy is usually assessed by comparing tumoral uptake to normal liver uptake as a reference. In this study, we aimed to compare tracer uptake intraindividually in various reference regions including liver, parotid gland and spleen as well as the respective tumor-to-background ratios (TBR) of different F-labeled PSMA ligands to today's standard radiopharmaceutical Ga-PSMA-11 in a series of patients with biochemical recurrence of prostate cancer who underwent a dual PSMA-PET examination as part of an individualized diagnostic approach.
View Article and Find Full Text PDFSafety and efficacy of staged coiling followed by flow diverter in the treatment of ruptured intracranial aneurysms.
Neurosurg Rev
January 2025
Department of Neurointervention, The First Affiliated Hospital of Zhengzhou University, 450052, Zhengzhou, Henan, China.
To evaluate the safety and efficacy of staged coiling followed by flow diverter (FD) in the treatment of ruptured intracranial aneurysms(RIAs). A retrospective analysis was conducted on 20 patients with RIAs treated with staged coiling followed by FD at a single center, between April 2015 and September 2024. Patient demographics, aneurysm characteristics, clinical and imaging outcomes were reviewed.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!