The objective of the study was to compare the efficacy and safety of frovatriptan and almotriptan in women with menstrually related migraine (IHS Classification of Headache disorders) enrolled in a multicenter, randomized, double-blind, cross-over study. Patients received frovatriptan 2.5 mg or almotriptan 12.5 mg in a randomized sequence: after treating 3 episodes of migraine in no more than 3 months with the first treatment, the patient was switched to the other treatment. 67 of the 96 female patients of the intention-to-treat population of the main study had regular menstrual cycles and were thus included in this subgroup analysis. 77 migraine attacks classified as related to menses were treated with frovatriptan and 78 with almotriptan. Rate of pain relief at 2 and 4 h was 36 and 53 % for frovatriptan and 41 and 50 % for almotriptan (p = NS between treatments). Rate of pain free at 2 and 4 h was 19 and 47 % with frovatriptan and 29 and 54 % for almotriptan (p = NS). At 24 h, 62 % of frovatriptan-treated and 67 % of almotriptan-treated patients had pain relief, while 60 versus 67 % were pain free (p = NS). Recurrence at 24 h was significantly (p
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The following endpoints were evaluated [37]: (a) the proportion of pain-relief episodes at 2, 4 and 24 h (a decrease in migraine intensity from severe or moderate to mild or none at 2, 4 and 24 h); (b) the proportion of pain-free episodes at 2, 4 and 24 h (absence of migraine episodes at 2, 4 and 24 h after intake of one dose of study drug); (c) recurrence within 24 h (episodes pain free at 2 h and headache of any severity returns within 24 h); (d) recurrence within 48 h. Changes in headache intensity (4-point scale from none to severe) from baseline after 2, 4, 24 and 48 h from study drug intake, were also evaluated.
As indicated in Table 2, the proportion of pain-relief episodes was similar (p = NS) between frovatriptan and almotriptan at 2 h (36 vs. 41 %), 4 h (53 vs. 50 %) and 24 h (62 vs. 67 %). Also the rate of pain-free episodes at 2, 4 and 24 h did not differ between the two treatment groups (19, 47 and 60 % frovatriptan vs. 29, 54 and 67 % almotriptan; p = NS for both) (Table 2).
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