Analysis of diroximel fumarate data for patients with relapsing forms of multiple sclerosis using related adverse events from the FDA adverse reporting system DOI
Jingya Yang,

Shengzhu Sun,

Sun Ying

et al.

Expert Opinion on Drug Safety, Journal Year: 2025, Volume and Issue: unknown, P. 1 - 8

Published: April 3, 2025

Diroximel fumarate (DRF) is an oral used to treat relapsing forms of multiple sclerosis (RMS). This study comprehensively analyzed the adverse events (AEs) associated with DRF for treating RMS based on data from FDA Adverse Event Reporting System (FAERS) database. collected AEs treatment FAERS database between 2019 and 2024. We reporting odds ratio (ROR), proportional (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), Multi-item Gamma Poisson Shrinker (MGPS) signal detection. 7,944,554 AE reports, which 7,868 were DRF. A total 120 preferred terms (PTs) included in analysis, relating 27 system organ classes (SOCs). identified several clinically significant new potential AEs, including decreased immune responsiveness (n = 26, ROR 4.45, PRR IC 2.15, EBGM 4.43), female breast cancer 50, 4.07, 2.02, 4.05), transient blindness 19, 7.27, 7.26, 2.85, 7.21) others. Our potentially important that not mentioned instructions. However, further epidemiologic studies are needed validate these findings.

Language: Английский

Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction in Patients With Multiple Sclerosis: A Pilot Trial DOI Creative Commons
Hanne Kobberø, Jan Krhút, Peter Zvara

et al.

Neurourology and Urodynamics, Journal Year: 2025, Volume and Issue: unknown

Published: April 14, 2025

ABSTRACT Aims We present results of a two‐arm pilot study assessing the feasibility conducting double‐blind randomized controlled trial (RCT) to evaluate efficacy sacral neuromodulation (SNM) in patients with multiple sclerosis (MS) suffering from neurogenic lower urinary tract dysfunction (NLUTD). Methods Eligible subjects refractory NLUTD and EDSS < 5 underwent SNM test phase. Those showing more than 50% improvement bladder variables, received implantable pulse generators (IPG) were either treatment group (IPG ON) or sham OFF) for 1 month. During second month, all had IPG ON until end trial. The primary endpoints feasibility, recruitment potential, response rate at Secondary endpoint was safety. Changes key diary‐derived variables patient reported outcomes recorded as well. Results Thirty‐two screened, 17 eligible 13 included Eleven considered responders implanted IPG. Subsequently, six five group. No serious adverse events reported. In intervention phase, both objective subjective improvements seen group, while symptoms remained mostly unchanged. At completion, being completely satisfied, three two indifferent treatment. Conclusions This demonstrated RCT safety MS patients. Trial registration: ClinicalTrials. gov NCT05380856.

Language: Английский

Citations

0
Beyond weight loss: exploring the neurological ramifications of altered gut microbiota post-bariatric surgery DOI Creative Commons

Rashed T. Almheiri,

Baraa Hajjar,

Saif M. I. Alkhaaldi

et al.

Journal of Translational Medicine, Journal Year: 2025, Volume and Issue: 23(1)

Published: Feb. 24, 2025

Language: Английский

Citations

0
Analysis of diroximel fumarate data for patients with relapsing forms of multiple sclerosis using related adverse events from the FDA adverse reporting system DOI
Jingya Yang,

Shengzhu Sun,

Sun Ying

et al.

Expert Opinion on Drug Safety, Journal Year: 2025, Volume and Issue: unknown, P. 1 - 8

Published: April 3, 2025

Diroximel fumarate (DRF) is an oral used to treat relapsing forms of multiple sclerosis (RMS). This study comprehensively analyzed the adverse events (AEs) associated with DRF for treating RMS based on data from FDA Adverse Event Reporting System (FAERS) database. collected AEs treatment FAERS database between 2019 and 2024. We reporting odds ratio (ROR), proportional (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), Multi-item Gamma Poisson Shrinker (MGPS) signal detection. 7,944,554 AE reports, which 7,868 were DRF. A total 120 preferred terms (PTs) included in analysis, relating 27 system organ classes (SOCs). identified several clinically significant new potential AEs, including decreased immune responsiveness (n = 26, ROR 4.45, PRR IC 2.15, EBGM 4.43), female breast cancer 50, 4.07, 2.02, 4.05), transient blindness 19, 7.27, 7.26, 2.85, 7.21) others. Our potentially important that not mentioned instructions. However, further epidemiologic studies are needed validate these findings.

Language: Английский

Citations

0