Dergiler / Nöropsikiyatri Arşivi / 2019 / Cilt: 56 - Sayı: 4

A 12-month, Open Label, Multicenter Pilot Study Evaluating Fingolimod Treatment in terms of Patient Satisfaction in Relapsing Remitting Multiple Sclerosis Patients - FINE Trial

Fingolimod Tedavisinin Yineleyici MS Hastalarındaki Etkilerini Değerlendiren Açık Etiketli, 12 Ay Süreli Pilot Çalışma - Fine Çalışma Grubu

Sayfa
253–257
DOI
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There were 124 adverse events and none of the five serious adverse events noted was considered drug-related.Conclusion: Large-scale comparative studies performed with disease specific quality of life instruments will allow more information on this issue

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Amaç & Hipotez:Introduction: To assess satisfaction and quality of life in patients with relapsing–remitting multiple sclerosis (RRMS) who were receiving fingolimod (0.5 mg/day) for 12 months as a second-line treatment after switching from injectable agents.Methods: Patients aged 18–65 years with RRMS who fulfilled the eligibility criteria were enrolled from 16 centers throughout Turkey.
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Temel Bulgular & Veri:Treatment Satisfaction Questionnaire for Medication and 36-item Short-Form Health Survey were completed at baseline and four visits to assess patient satisfaction and quality of life.Results: Forty-two patients (62% male; mean age: 35.7±9.4 years) were eligible for inclusion.
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Sonuç & Katkı:There were 124 adverse events and none of the five serious adverse events noted was considered drug-related.Conclusion: Large-scale comparative studies performed with disease specific quality of life instruments will allow more information on this issue
🔬Tür:Uygulamalı Anket & Alan Araştırması
📍Kapsam:Genişletilmiş Akademik Örneklem
⚙️Değişkenler:Alan Parametreleri

Özet

Introduction: To assess satisfaction and quality of life in patients with relapsing–remitting multiple sclerosis (RRMS) who were receiving fingolimod (0.5 mg/day) for 12 months as a second-line treatment after switching from injectable agents.Methods: Patients aged 18–65 years with RRMS who fulfilled the eligibility criteria were enrolled from 16 centers throughout Turkey. Treatment Satisfaction Questionnaire for Medication and 36-item Short-Form Health Survey were completed at baseline and four visits to assess patient satisfaction and quality of life.Results: Forty-two patients (62% male; mean age: 35.7±9.4 years) were eligible for inclusion. Patient satisfaction scores at the end of the study (44.7±9.9) were significantly higher than those at baseline [32.0±9.9; (p<0.001)]. The only significant increase in the quality of life survey was in the emotional aspect (p=0.019). There were 124 adverse events and none of the five serious adverse events noted was considered drug-related.Conclusion: Large-scale comparative studies performed with disease specific quality of life instruments will allow more information on this issue

Abstract

Amaç: Prospektif, çok merkezli bu çalışmanın amacı, enjekte edilebilir ajanlardan sonra ikinci basamak ilaç olarak 12 ay süreyle 0,5 mg/gün dozunda fingolimod kullanan yineleyici multipl skleroz hastalarının memnuniyetlerinin ve yaşam kalitelerinin değerlendirilmesidir.Yöntem: Çalışmaya Türkiye genelinde 16 merkezden, 18-65 yaş arasında, dahil etme kriterlerini karşılayan yineleyici multipl skleroz hastaları katılmışlardır. Hastalara; memnuniyetlerinin ve yaşam kalitelerinin değerlendirmesi amacı ile başlangıç ve takip eden diğer dört vizitte İlaç Memnuniyet Anketi ve Kısa Form-36 Sağlık Durumu Anketi uygulanmıştır.Bulgular: Yaş ortalamaları 35,7±9,4 olan ve %62’sini erkek hastaların oluşturduğu toplamda 42 hasta çalışmaya dahil edilmiştir. Çalışmanın sonunda hasta memnuniyeti skorları (44,7±9,9) çalışma başlangıcına (32,0±9,9) kıyasla anlamlı olarak yüksek bulunmuştur (p<0,001). Yaşam kalitesi anketi sonuçlarında ise yalnızca emosyenel fonksiyon skorunda bir artış görülmüştür (p=0,019). Çalışma süresince 124 advers olay kaydedilirken, rapor edilen 5 ciddi advers olaydan hiçbiri ilaçla ilişkili olarak değerlendirilmemiştir.Sonuç: Hastalığa özgü yaşam kalitesi değerlendirme yöntemleri ile gerçekleştirilecek olan geniş ölçekli karşılaştırma çalışmaları, bu konuda daha çok bilgi alınmasına olanak sağlayacaktır.

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Bu Makaleye Atıf Yap

DEMİR, G. A., TÜRKOĞLU, R., SAİP, S., YÜCEYAR, N., EFENDİ, H., TURAN, Ö. F., AĞAN, K., TERZİ, M., BOZ, C., TUNCER, A., KOÇER, B., KASAP, M., ÇALIŞKAN, Z., GROUP, F. S. (2019). A 12-month, Open Label, Multicenter Pilot Study Evaluating Fingolimod Treatment in terms of Patient Satisfaction in Relapsing Remitting Multiple Sclerosis Patients - FINE Trial. Nöropsikiyatri Arşivi, Cilt: 56 - Sayı: 4, 253–257. https://ajindex.com/articles/292248

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Kaynakça (4)

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