Clinical and Demographic Characteristics and Two-Year Efficacy and Safety Data of 508 Multiple Sclerosis Patients with Fingolimod Treatment.

Autor: Terzi M; Ondokuz Mayıs University Faculty of Medicine Department of Neurology, Samsun, Turkey., Helvacı EM; Ondokuz Mayıs University Graduate School of Education, Department of Neuroscience, Samsun, Turkey., Şen S; Ondokuz Mayıs University Faculty of Medicine Department of Neurology, Samsun, Turkey., Boz C; Karadeniz Technical University Faculty of Medicine Department of Neurology, Trabzon, Turkey., Çilingir V; Van Yüzüncü Yıl University Faculty of Medicine Department of Neurology, Van, Turkey., Akçalı A; Gaziantep University Faculty of Medicine Department of Neurology, Gaziantep, Turkey., Beckmann Y; İzmir Katip Çelebi University Faculty of Medicine Department of Neurology, İzmir, Turkey., Uzunköprü C; İzmir Katip Çelebi University Faculty of Medicine Department of Neurology, İzmir, Turkey., Türkoğlu R; Health Sciences University Haydarpaşa Numune Training and Research Hospital, Department of Neurology, İstanbul, Turkey., Yüceyar N; Ege University Faculty of Medicine Department of Neurology, İzmir, Turkey., Efendi H; Kocaeli University Faculty of Medicine Department of Neurology, Kocaeli, Turkey., Bünül SD; Kocaeli University Faculty of Medicine Department of Neurology, Kocaeli, Turkey., Seferoğlu M; Bursa High Specialization Training and Research Hospital Neurology Clinic, Bursa, Turkey., Kotan D; Sakarya University Faculty of Medicine, Sakarya Training and Research Hospital Neurology Clinic, Sakarya, Turkey., Güler S; Trakya University Faculty of Medicine Department of Neurology, Edirne, Turkey., Balcı BP; Health Sciences University Haseki Training and Research Hospital Neurology Clinic, İstanbul, turkey., Öztürk B; Health Sciences University Ankara Gülhane Training and Research Hospital Neurology Clinic, Ankara, Turkey., Mungan S; Ankara City Hospital Neurology Clinic, Ankara, Turkey., İçen NK; Health Sciences University Bağcılar Training and Research Hospital Neurology Clinic, İstanbul, Turkey., Ömerhoca S; Health Sciences University Bağcılar Training and Research Hospital Neurology Clinic, İstanbul, Turkey., Yurtoğulları Ş; Ankara Gaziler Physical Therapy Rehabilitation Training and Research Hospital Neurology Clinic, Ankara, Turkey., Sevim S; Mersin University Faculty of Medicine Department of Neurology, Mersin, Turkey., Türkoğlu ŞA; Bolu İzzet Baysal University Faculty of Medicine Department of Neurology, Bolu, Turkey., Çam M; Çanakkale On Sekiz Mart University Faculty of Medicine Department of Neurology, Çanakkale, Turkey., Yetkin MF; Erciyes University Faculty of Medicine Department of Neurology, Kayseri, Turkey., Yoldaş TK; Ankara Training and Research Hospital Neurology Clinic, Ankara, Turkey., Sıvacı AÖ; Bursa High Specialization Training and Research Hospital Neurology Clinic, Bursa, Turkey., Gökçe ŞF; Cumhuriyet University Faculty of Medicine Department of Neurology, Sivas, Turkey., Gürsoy E; Bezmi Alem Vakıf University Faculty of Medicine Department of Neurology, İstanbul, Turkey., Ünal A; Namık Kemal University Faculty of Medicine Department of Neurology, Tekirdağ, Turkey., Bilge N; Atatürk University Faculty of Medicine Department of Neurology, Erzurum, Turkey., Ağan K; Marmara University Faculty of Medicine Department of Neurology, İstanbul, Turkey., Toprak MK; Ankara Başkent University Faculty of Medicine Department of Neurology, Ankara, Turkey., Koçer B; Ankara Gazi University Faculty of Medicine Department of Neurology, Ankara, Turkey., Sezer G; Medipol University, Faculty of Pharmacy, Ankara, Turkey., Terzi Y; Ondokuz Mayıs University, Faculty of Arts and Sciences, Department of Statistics, Samsun, Turkey.
Jazyk: angličtina
Zdroj: Noro psikiyatri arsivi [Noro Psikiyatr Ars] 2023 Jan 13; Vol. 60 (1), pp. 23-27. Date of Electronic Publication: 2023 Jan 13 (Print Publication: 2023).
DOI: 10.29399/npa.28081
Abstrakt: Introduction: 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.
Method: 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 th and 24 th month following the treatment. The data were analyzed using the IBM SPSS 20.00. P value of <0.05 was considered to be statistically significant.
Results: 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.
Conclusion: 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.
Competing Interests: Conflict of Interest: The authors declared that there is no conflict of interest.
(Copyright: © 2023 Turkish Neuropsychiatric Society.)
Databáze: MEDLINE