Michel Aubé¹, Fridon Chouha^2,3, Julie Vaillancourt³ and John Sampalis^3,4

¹The Montreal Neurological Institute, Montreal, Canada. ²Merck Frosst Canada Ltd., Kirkland, Canada. ³JSS Medical Research, Montreal, Canada. ⁴Mcgill University, Montreal, Canada.

Abstract

Background: Patients that do not achieve therapeutic response with over the counter non-triptan medications may benefit from triptan-based treatments.

Objective: Phase IV, open-label, multi-center, prospective cohort study assessing the effectiveness of rizatriptan in the management of migraines for patients that have not responded to non-triptan treatment.

Methods: Patients were treated with one rizatriptan (MAXALT RPD^®) 10 mg wafer at the onset of each migraine attack and were assessed after a minimum of one and a maximum of two consecutive headache episodes. Outcome measures included self-reported assessments (severity and duration of migraine headache) and the Migraine ACT questionnaire.

Results: A total of 369 patients were enrolled, of which 291 and 215 reported one and two attacks, respectively. For the first and second attacks, 47.2% and 53.9% of patients reported complete resolution of pain while 73.6% and 77.0% reported pain severity reduction within two hours of onset. Mean (SD) pain severity score (four-point Likert scale) during the 488 migraine episodes was reduced significantly (P , 0.001) from 2.56 (0.49) at onset to 1.91 (0.85) at 30, 1.31 (1.00) at 60 and 0.84 (1.00) at 120 minutes. Similar improvements were observed for changes in Migraine ACT questionnaire scores. No treatment-related serious adverse events were reported. The most frequently reported non-serious adverse events that were attributed to the study drug were dizziness (2.2%), chest discomfort (1.1%), nausea (1.1%), and somnolence (0.8%).

Conclusion: In a real-life setting, rizatriptan benzoate 10 mg is effective and safe in the treatment of acute migraine headaches in patients who do not respond to non-triptan treatment.