Literature DB >> 31903032

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

Gülşen Akman Demır1, Recai Türkoğlu2, Sabahattin Saıp3, Nur Yüceyar4, Hüsnü Efendı5, Ömer Faruk Turan6, Kadriye Ağan7, Murat Terzı8, Cavit Boz9, Aslı Tuncer10, Belgin Koçer11, Mithat Kasap12, Zeynep Çalişkan12.   

Abstract

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. Copyright:
© 2019 Turkish Neuropsychiatric Society.

Entities:  

Keywords:  Multiple sclerosis; fingolimod; patient satisfaction; quality of life

Year:  2017        PMID: 31903032      PMCID: PMC6927087          DOI: 10.5152/npa.2017.20515

Source DB:  PubMed          Journal:  Noro Psikiyatr Ars        ISSN: 1300-0667            Impact factor:   1.339


  23 in total

1.  Safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (FREEDOMS II): a double-blind, randomised, placebo-controlled, phase 3 trial.

Authors:  Peter A Calabresi; Ernst-Wilhelm Radue; Douglas Goodin; Douglas Jeffery; Kottil W Rammohan; Anthony T Reder; Timothy Vollmer; Mark A Agius; Ludwig Kappos; Tracy Stites; Bingbing Li; Linda Cappiello; Philipp von Rosenstiel; Fred D Lublin
Journal:  Lancet Neurol       Date:  2014-03-28       Impact factor: 44.182

2.  A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis.

Authors:  Ludwig Kappos; Ernst-Wilhelm Radue; Paul O'Connor; Chris Polman; Reinhard Hohlfeld; Peter Calabresi; Krzysztof Selmaj; Catherine Agoropoulou; Malgorzata Leyk; Lixin Zhang-Auberson; Pascale Burtin
Journal:  N Engl J Med       Date:  2010-01-20       Impact factor: 91.245

3.  Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis.

Authors:  Jeffrey A Cohen; Frederik Barkhof; Giancarlo Comi; Hans-Peter Hartung; Bhupendra O Khatri; Xavier Montalban; Jean Pelletier; Ruggero Capra; Paolo Gallo; Guillermo Izquierdo; Klaus Tiel-Wilck; Ana de Vera; James Jin; Tracy Stites; Stacy Wu; Shreeram Aradhye; Ludwig Kappos
Journal:  N Engl J Med       Date:  2010-01-20       Impact factor: 91.245

4.  Fingolimod versus intramuscular interferon in patient subgroups from TRANSFORMS.

Authors:  Jeffrey A Cohen; Frederik Barkhof; Giancarlo Comi; Guillermo Izquierdo; Bhupendra Khatri; Xavier Montalban; Jean Pelletier; Benjamin Eckert; Dieter A Häring; Gordon Francis
Journal:  J Neurol       Date:  2013-04-30       Impact factor: 4.849

5.  Oral fingolimod in primary progressive multiple sclerosis (INFORMS): a phase 3, randomised, double-blind, placebo-controlled trial.

Authors:  Fred Lublin; David H Miller; Mark S Freedman; Bruce A C Cree; Jerry S Wolinsky; Howard Weiner; Catherine Lubetzki; Hans-Peter Hartung; Xavier Montalban; Bernard M J Uitdehaag; Martin Merschhemke; Bingbing Li; Norman Putzki; Fonda C Liu; Dieter A Häring; Ludwig Kappos
Journal:  Lancet       Date:  2016-01-28       Impact factor: 79.321

6.  Long-term effects of fingolimod in multiple sclerosis: the randomized FREEDOMS extension trial.

Authors:  Ludwig Kappos; Paul O'Connor; Ernst-Wilhelm Radue; Chris Polman; Reinhard Hohlfeld; Krzysztof Selmaj; Shannon Ritter; Rolf Schlosshauer; Philipp von Rosenstiel; Lixin Zhang-Auberson; Gordon Francis
Journal:  Neurology       Date:  2015-03-20       Impact factor: 9.910

Review 7.  Clinical efficacy, safety, and tolerability of fingolimod for the treatment of relapsing-remitting multiple sclerosis.

Authors:  Alberto Gajofatto; Marco Turatti; Salvatore Monaco; Maria Donata Benedetti
Journal:  Drug Healthc Patient Saf       Date:  2015-12-11

8.  Impact of a switch to fingolimod versus staying on glatiramer acetate or beta interferons on patient- and physician-reported outcomes in relapsing multiple sclerosis: post hoc analyses of the EPOC trial.

Authors:  Jonathan Calkwood; Bruce Cree; Heidi Crayton; Daniel Kantor; Brian Steingo; Luigi Barbato; Ron Hashmonay; Neetu Agashivala; Kevin McCague; Nadia Tenenbaum; Keith Edwards
Journal:  BMC Neurol       Date:  2014-11-26       Impact factor: 2.474

9.  Assessment of cardiac safety during fingolimod treatment initiation in a real-world relapsing multiple sclerosis population: a phase 3b, open-label study.

Authors:  Ralf Gold; Giancarlo Comi; Jacqueline Palace; Arno Siever; Rebecca Gottschalk; Mahendra Bijarnia; Philipp von Rosenstiel; Davorka Tomic; Ludwig Kappos
Journal:  J Neurol       Date:  2013-11-13       Impact factor: 4.849

Review 10.  Current and future therapies for multiple sclerosis.

Authors:  Alireza Minagar
Journal:  Scientifica (Cairo)       Date:  2013-02-07
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