Clinical and Demographic Characteristics and Two-Year Efficacy and Safety Data of 508 Multiple Sclerosis Patients with Fingolimod Treatment.
Efficacy
fingolimod
multiple sclerosis
safety
Journal
Noro psikiyatri arsivi
ISSN: 1300-0667
Titre abrégé: Noro Psikiyatr Ars
Pays: Turkey
ID NLM: 9426194
Informations de publication
Date de publication:
2023
2023
Historique:
received:
11
12
2021
accepted:
20
04
2022
entrez:
13
3
2023
pubmed:
14
3
2023
medline:
14
3
2023
Statut:
epublish
Résumé
Fingolimod is the first oral immunomodulatory treatment used as secondary care therapy in the treatment of multiple sclerosis for the last 10 years. The objective of our study is to reveal the experiences of the first generic fingolimod active ingredient treatment in different centers across Turkey. The first generic fingolimod efficacy and safety data of patients followed-up in 29 different clinical multiple sclerosis units in Turkey were analyzed retrospectively. Data regarding efficacy and safety of the patients were transferred to the data system both before the treatment and on the 6th, 12 A total of 508 multiple sclerosis patients, 331 of whom were women, were included in the study. Upon comparing the Expanded Disability Status values before and after the treatment, a significant decrease was observed, especially at month 6 and thereafter. Since bradycardia occurred in 11 of the patients (2.3%), the first dose had to be longer than 6 hours. During the observation of the first dose, no issues that could prevent the use of the drug occured. Side effects were seen in 49 (10.3%) patients during the course of fingolimod treatment. Respectively, the most frequent side effects were bradycardia, hypotension, headache, dizziness and tachycardia. The observed results regarding efficacy and safety were similar to clinical trial data in the literature and real life data in terms of the first equivalent with fingolimod active ingredient.
Identifiants
pubmed: 36911568
doi: 10.29399/npa.28081
pii: archneuro-60-23
pmc: PMC9999220
doi:
Types de publication
Journal Article
Langues
eng
Pagination
23-27Commentaires et corrections
Type : ErratumIn
Informations de copyright
Copyright: © 2023 Turkish Neuropsychiatric Society.
Déclaration de conflit d'intérêts
Conflict of Interest: The authors declared that there is no conflict of interest.
Références
N Engl J Med. 2018 Sep 13;379(11):1017-1027
pubmed: 30207920
Expert Opin Pharmacother. 2017 Oct;18(15):1649-1660
pubmed: 28844164
N Engl J Med. 2010 Feb 4;362(5):402-15
pubmed: 20089954
Nat Rev Neurol. 2010 Jul;6(7):373-82
pubmed: 20551946
N Engl J Med. 2012 Jan 26;366(4):339-47
pubmed: 22276823
Patient Prefer Adherence. 2010 Feb 04;4:1-9
pubmed: 20165593
P T. 2012 Mar;37(3):175-84
pubmed: 22605909
Noro Psikiyatr Ars. 2019 Mar;56(1):23-26
pubmed: 30911233
Noro Psikiyatr Ars. 2017 Jun 22;56(4):253-257
pubmed: 31903032
Lancet Neurol. 2014 Jun;13(6):545-56
pubmed: 24685276
N Engl J Med. 2010 Feb 4;362(5):387-401
pubmed: 20089952
BMC Neurol. 2017 Jan 28;17(1):17
pubmed: 28129749