Objective: This post hoc subgroup analysis evaluated scheduled short-term preventive frovatriptan therapy for women with migraine occurring exclusively in association with menstruation (occurring day -2 to +3; day 1 = menses start, no migraines outside this window).
Background: A previously published randomized, double-blind, placebo-controlled 3-way crossover trial assessed the efficacy and safety of a scheduled 6-day preventive regimen with frovatriptan for the treatment of menstrual migraine; the study population included women experiencing both menstrual and non-menstrual migraine and women experiencing only menstrual migraine.
Methods: Women received each treatment (placebo, frovatriptan 2.5 mg once daily, and frovatriptan 2.5 mg twice daily) once over 3 perimenstrual periods in randomized sequence. For this subset analysis, screening questions were used to identify women with migraine occurring exclusively in association with menstruation. Efficacy was evaluated by occurrence and severity of migraine, functional impairment, and rescue medication use. Adverse events and tolerability were also assessed.
Results: Among 179 patients, the mean age (SD) was 37.3 (7.7) years and mean menstrual migraine history was 10.6 (8.7) years. Significantly fewer women experienced menstrual migraine during treatment with frovatriptan twice daily (37.7%, P < .001) or once daily (51.3%, P = .002) than during treatment with placebo (67.1%); a significant dose response was noted (P = .01, twice daily vs once daily). Significant treatment differences were also found for several secondary endpoints, but the data from this post hoc analysis must be interpreted with caution. Frovatriptan was well tolerated and most adverse events were mild or moderate and similar to those reported with the acute treatment of migraine with frovatriptan; the most common adverse events were nausea, dizziness, and headache.
Conclusions: Scheduled short-term preventive frovatriptan therapy effectively reduced the occurrence of menstrual migraine in women with attacks occurring exclusively in association with menstruation.
Trial registration: ClinicalTrials.gov NCT00644033.