Literature DB >> 29218681

Management Strategies to Facilitate Optimal Outcomes for Patients Treated with Delayed-release Dimethyl Fumarate.

Lori Mayer1, Mary Kay Fink2, Carrie Sammarco3, Lisa Laing3.   

Abstract

Delayed-release dimethyl fumarate is an oral disease-modifying therapy that has demonstrated significant efficacy in adults with relapsing-remitting multiple sclerosis. Incidences of flushing and gastrointestinal adverse events are common in the first month after delayed-release dimethyl fumarate initiation. Our objective was to propose mitigation strategies for adverse events related to initiation of delayed-release dimethyl fumarate in the treatment of patients with multiple sclerosis. Studies of individually developed mitigation strategies and chart reviews were evaluated. Those results, as well as mitigation protocols developed at multiple sclerosis care centers, are summarized. Key steps to optimize the effectiveness of delayed-release dimethyl fumarate treatment include education prior to and at the time of delayed-release dimethyl fumarate initiation, initiation dose protocol gradually increasing to maintenance dose, dietary suggestions for co-administration with food, gastrointestinal symptom management with over-the-counter medications, flushing symptom management with aspirin, and temporary dose reduction. Using the available evidence from clinical trials and evaluations of post-marketing studies, these strategies to manage gastrointestinal and flushing symptoms can be effective and helpful to the patient when initiating delayed-release dimethyl fumarate.

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Year:  2018        PMID: 29218681     DOI: 10.1007/s40264-017-0621-3

Source DB:  PubMed          Journal:  Drug Saf        ISSN: 0114-5916            Impact factor:   5.606


  22 in total

1.  Managing flushing and gastrointestinal events associated with delayed-release dimethyl fumarate: Experiences of an international panel.

Authors:  J Theodore Phillips; Michael Hutchinson; Robert Fox; Ralf Gold; Eva Havrdova
Journal:  Mult Scler Relat Disord       Date:  2014-04-01       Impact factor: 4.339

2.  Clinical Significance of Gastrointestinal and Flushing Events in Patients with Multiple Sclerosis Treated with Delayed-Release Dimethyl Fumarate.

Authors:  J Theodore Phillips; Krzysztof Selmaj; Ralf Gold; Robert J Fox; Eva Havrdova; Gavin Giovannoni; Heather Abourjaily; Amy Pace; Mark Novas; Christophe Hotermans; Vissia Viglietta; Leslie Meltzer
Journal:  Int J MS Care       Date:  2015 Sep-Oct

3.  Effects of delayed-release dimethyl fumarate (DMF) on health-related quality of life in patients with relapsing-remitting multiple sclerosis: an integrated analysis of the phase 3 DEFINE and CONFIRM studies.

Authors:  Mariko Kita; Robert J Fox; Ralf Gold; Gavin Giovannoni; J Theodore Phillips; Sujata P Sarda; Jessica Kong; Vissia Viglietta; Sarah I Sheikh; Macaulay Okwuokenye; Ludwig Kappos
Journal:  Clin Ther       Date:  2014-10-12       Impact factor: 3.393

4.  Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis.

Authors:  Robert J Fox; David H Miller; J Theodore Phillips; Michael Hutchinson; Eva Havrdova; Mariko Kita; Minhua Yang; Kartik Raghupathi; Mark Novas; Marianne T Sweetser; Vissia Viglietta; Katherine T Dawson
Journal:  N Engl J Med       Date:  2012-09-20       Impact factor: 91.245

5.  Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis.

Authors:  Ralf Gold; Ludwig Kappos; Douglas L Arnold; Amit Bar-Or; Gavin Giovannoni; Krzysztof Selmaj; Carlo Tornatore; Marianne T Sweetser; Minhua Yang; Sarah I Sheikh; Katherine T Dawson
Journal:  N Engl J Med       Date:  2012-09-20       Impact factor: 91.245

6.  The Global Adherence Project (GAP): a multicenter observational study on adherence to disease-modifying therapies in patients with relapsing-remitting multiple sclerosis.

Authors:  V Devonshire; Y Lapierre; R Macdonell; C Ramo-Tello; F Patti; P Fontoura; L Suchet; R Hyde; I Balla; E M Frohman; B C Kieseier
Journal:  Eur J Neurol       Date:  2011-01       Impact factor: 6.089

Review 7.  Molecular pathogenesis of multiple sclerosis.

Authors:  A Bar-Or; E M Oliveira; D E Anderson; D A Hafler
Journal:  J Neuroimmunol       Date:  1999-12       Impact factor: 3.478

8.  Deterioration in the health-related quality of life of persons with multiple sclerosis: the possible warning signs.

Authors:  K V L Turpin; L J Carroll; J D Cassidy; W J Hader
Journal:  Mult Scler       Date:  2007-09       Impact factor: 6.312

Review 9.  The Use of Oral Disease-Modifying Therapies in Multiple Sclerosis.

Authors:  Benedikt Kretzschmar; Hannah Pellkofer; Martin S Weber
Journal:  Curr Neurol Neurosci Rep       Date:  2016-04       Impact factor: 5.081

10.  Efficacy of delayed-release dimethyl fumarate in relapsing-remitting multiple sclerosis: integrated analysis of the phase 3 trials.

Authors:  Vissia Viglietta; David Miller; Amit Bar-Or; J Theodore Phillips; Douglas L Arnold; Krzysztof Selmaj; Mariko Kita; Michael Hutchinson; Minhua Yang; Ray Zhang; Katherine T Dawson; Sarah I Sheikh; Robert J Fox; Ralf Gold
Journal:  Ann Clin Transl Neurol       Date:  2014-12-04       Impact factor: 4.511

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