The efficacy and safety of subcutaneous sumatriptan in the acute treatment of menstrual migraine. The Sumatriptan Menstrual Migraine Study Group.

OBJECTIVE

To compare the efficacy and safety of subcutaneous sumatriptan with placebo in the treatment of menstrual migraine.

METHODS

A double-blind, placebo-controlled, parallel group study was conducted to assess the efficacy and safety of subcutaneous sumatriptan in the treatment of menstrual migraine over two attacks. A total of 179 subjects received sumatriptan or placebo to treat at least one menstrual migraine attack.

RESULTS

The efficacy results were consistent for attacks one and two. Two hours after treatment in attacks one and two, 53 (73%) and 51 (81%) of the sumatriptan-treated subjects, respectively, reported headache relief (reduction of a severe or moderately severe headache to a mild or no headache), compared with 27 (31%) and 18 (29%) of the placebo-treated subjects (P < .001). Within 24 hours of treatment in attack one, 28 (53%) and 14 (52%) of the initial responders to sumatriptan and placebo, respectively, experienced headache recurrence. The incidence and nature of adverse events in this study were similar to that seen in previous studies.

CONCLUSIONS

Subcutaneous sumatriptan is an effective and well-tolerated acute treatment for menstrual migraine.