Loading your page…
Dove Medical Press
By Richard Lipton, Dawn Buse, Vincent Martin and 5 others.
Ward brings these articles into the same app as your cards and questions. One free account for Ward, Suture, Osler and Prognia.
Richard B Lipton,1 Dawn C Buse,1 Vincent T Martin,2 Dave Semel,3 Joseph C Cappelleri,4 Alexandra Thiry,4 Lucy Abraham,5 Terence Fullerton31Department of Neurology, Albert Einstein College of Medicine, Bronx, NY, USA; 2Headache and Facial Pain Center, University of Cincinnati, Cincinnati, OH, USA; 3Medical Affairs, Pfizer Inc, New York, NY, USA; 4Department of Statistics, Pfizer Inc, Groton, CT, USA; 5Health Economics & Outcomes Research, Pfizer R&D UK Ltd, Tadworth, UKCorrespondence: Vincent T Martin, Headache and Facial Pain Center, University of Cincinnati, Cincinnati, OH, USA, Email MARTINVT@UCMAIL.UC.EDUPurpose: The current exploratory analysis of a Phase 2/3 randomized controlled trial focusses on patient-reported outcome measures from a 64-week study evaluating rimegepant for the preventive treatment of migraine in the USA.Methods: Participants with migraine were randomly assigned to rimegepant 75 mg or placebo every other day during a 12-week double-blind treatment (DBT) phase. During a 52-week open-label extension (OLE) phase all participants took rimegepant 75 mg every other day and additionally on nonscheduled dosing days if needed. Migraine-Specific Quality of Life Questionnaire (MSQ) v.2.1 (including Role Function Restrictive [RFR] domain) and Migraine Disability Assessment Scale (MIDAS) were assessed throughout.Results: 741 participants (mean [standard deviation] age 41.2 [13.06] years, 82.7% female) were treated with ≥ 1 dose of study drug in the DBT phase, and 603 participants were treated with rimegepant in the OLE phase. At Week 12 (end of DBT phase), for the rimegepant and placebo groups, respectively, mean (95% CI) improvements from baseline in MSQ RFR score were 18.6 (16.24, 20.94) and 15.0 (12.60, 17.37), and improvements in MIDAS Total score were − 13.0 (− 16.57, − 9.52) and − 12.0 (− 15.52, − 8.54). At Week 64 (end of OLE phase, all participants taking open-label rimegepant), for participants originally assigned DBT rimegepant and DBT placebo, respectively, mean (95% CI) improvements from baseline in MSQ RFR score were 32.6 (29.68, 35.42) and 33.2 (30.03, 36.29), and improvements from baseline in MIDAS Total Score were − 25.4 (− 30.23, − 20.48) and − 24.4 (− 28.29, − 20.59).Conclusion: Notable numerical benefit for rimegepant versus placebo was observed at the end of the DBT phase (Week 12) for MSQ RFR domain score. During open-label treatment with rimegepant, improvements from baseline in MSQ domain scores and MIDAS Total Score were clinically meaningful at Week 64. Participants who received placebo in the DBT phase achieved similar benefit when they moved into the OLE phase as those who took rimegepant from the start of the study.Trial Registration: Clinicaltrials.gov NCT03732638.Keywords: calcitonin gene-related peptide receptor antagonist, disability, migraine, quality of life
Published in Dove Medical Press (Taylor and Francis Group). The abstract is shown as published and remains the work of its authors; read the full article at the source.
dovepress.com/improvements-in-patient-reported-outcome-measures-through-64-weeks
Prognia lists this article for reference and education. It is not medical advice. Always read the original and follow current guidelines and local protocols before acting on it.
