The objectives of this study are to assess the efficacy and safety of
frovatriptan, and
rizatriptan in the subgroup of women with menstrually related
migraine of a multicenter, randomized, double blind, cross-over study. Each patient received
frovatriptan 2.5 mg or
rizatriptan 10 mg in a randomized sequence: after treating 3 episodes of
migraine in not more than 3 months with the first treatment, the patient had to switch to the other treatment. Menstrually related
migraine was defined according to the criteria listed in the Appendix of the last IHS Classification of
Headache disorders. 99 out of the 125 patients included in the intention-to-treat analysis of the main study were of a female gender: 93 had regular menstrual cycles and were, thus, included in this analysis. A total of 49 attacks classified as menstrually related
migraine were treated with
frovatriptan and 59 with
rizatriptan. Rate of
pain relief at 2 h was 58% for
frovatriptan and 64% for
rizatriptan (p = NS), while rate of
pain free at 2 h was 31 and 34% (p = NS), respectively. At 24 h, 67 and 81% of
frovatriptan-treated, and 61 and 74% of
rizatriptan-treated patients were
pain free and had
pain relief, respectively (p = NS). Recurrence at 24 h was significantly (p < 0.01) lower with
frovatriptan (10 vs. 32%
rizatriptan).
Frovatriptan was as effective as
rizatriptan in the immediate treatment of menstrually related
migraine attacks while showing a favorable sustained effect with a lower rate of
migraine recurrence. These results need to be confirmed by randomized, double-blind, prospective, large clinical trials.