Neuroscience and Behavioral Physiology

, Volume 47, Issue 1, pp 102–106 | Cite as

Results of a Randomized Open Multicenter Comparative Study of the Tolerability and Safety of Gilenya (fingolimod) in Patients with Remitting Multiple Sclerosis (the GIMN study)

  • E. V. Popova
  • A. N. Boiko
  • O. V. Boiko
  • (for the study group)
Article

Disease-modifying drugs (DMD) are currently used in the treatment of patients with multiple sclerosis (MS) in accordance with therapeutic standards, with the aim of decreasing the risk of developing exacerbations and thus reducing the rate of development of disability. However, the use of first-line substances is not successful in all cases. Second-line agents are used in this situation, which on the territories of the Russian Federation include fingolimod. Experience in the use of fingolimod in routine neurological practice was obtained by performing the postmarketing GIMN trial.

Keywords

multiple sclerosis fingolimod quality of life compliance 

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References

  1. 1.
    A. L. Stewart, S. Greenfield, R. D. Hays, et al., “Functional status and wellbeing of patients with chronic conditions. Results from the Medical Outcomes Study,” JAMA, 262, 907–913 (1989).CrossRefPubMedGoogle Scholar
  2. 2.
    L. Kappos et al., “Long-term efficacy and safety of fingolimod (FTY720) in relapsing-remitting multiple sclerosis (RRMS): Results from the extension of the phase III FREEDOMS study,” ECTRIMS 2012, Poster P979.Google Scholar
  3. 3.
    L. Kappos et al., “A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis,” N. Engl. J. Med., 362, 387–401 (2010).CrossRefPubMedGoogle Scholar
  4. 4.
    J. Cohen et al., “Fingolimod versus intramuscular interferon in patient subgroups from TRANSFORMS,” J. Neurol., 260, 2023–2032 (2013).CrossRefPubMedPubMedCentralGoogle Scholar
  5. 5.
    X. Montalban, “From long-term treatment monitoring, Long-term comparison of fingolimod with interferon-beta-1a: results of 4.5-year follow-up from the extension phase III TRANSFORMS study,” Abstr. ECTRIMS 2012.Google Scholar
  6. 6.
    W. I. McDonald, A. Compston, G. Edan, et al., “Recommended diagnosis criteria for multiple sclerosis: Guidelines from the international panel on the diagnosis of multiple sclerosis,” Ann. Neurol., 50, 121–127 (2001).CrossRefPubMedGoogle Scholar
  7. 7.
    C. H. Polman, S. C. Reingold, G. Edan, et al., “Diagnostic criteria for multiple sclerosis: 2005 revisions to the ‘McDonald Criteria’,” Ann. Neurol., 58, 840–846 (2005).CrossRefPubMedGoogle Scholar
  8. 8.
    J. F. Kurtzke, “Rating neurologic impairment in multiple sclerosis: An expanded disability status scale (EDSS),” Neurology, 33, 1444–1452 (1983).CrossRefPubMedGoogle Scholar
  9. 9.
    M. J. Sullivan, B. Weinshenker, et al., “Screening for major depression in the early stages of multiple sclerosis,” Can. J. Neurol. Sci., 22, 228–231 (1995).CrossRefPubMedGoogle Scholar
  10. 10.
    M. J. Atkinson, A. Sinha, S. L. Hass, et al., “Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease,” Health Qual. Life Outcomes, 2, 12 (2004).CrossRefPubMedPubMedCentralGoogle Scholar
  11. 11.
    J. E. Brazier, R. Harper, N. M. Jones, et al., “Validating the SF-36 health survey questionnaire: new outcome measure for primary care,” Br. Med. J., 305, 160–164 (1992).CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media New York 2016

Authors and Affiliations

  • E. V. Popova
    • 1
    • 2
  • A. N. Boiko
    • 1
    • 2
  • O. V. Boiko
    • 1
    • 2
  • (for the study group)
  1. 1.Department of Neurology, Neurosurgery, and Medical GeneticsPirogov Russian National Medical Research UniversityMoscowRussia
  2. 2.Moscow City Multiple Sclerosis Center at City Clinical Hospital No. 24MoscowRussia

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