To compare the clinical characteristics of menstrually related
migraines (MRMs) and nonmenstrually related
migraines (nonMRMs) and to investigate the efficacy of
almotriptan in the treatment of these
migraine subtypes.
DESIGN/METHODS: These are post hoc analyses of data from the
AXERT Early
miGraine Intervention Study (AEGIS), a multicenter, double-blind, parallel-group trial that evaluated adults with IHS-defined
migraine with and without
aura. Patients were randomized 1:1 to treat 3 consecutive
headaches with
almotriptan 12.5 mg or matching placebo at the first sign of
headache typical of their usual
migraine, at any level of
pain intensity but within 1 hour of onset. MRMs were defined as those occurring +/-2 days of the first day of menstrual flow. Post hoc analyses to describe
headache characteristics pooled all
migraine attacks experienced by patients who reported > or = 1 menses during the study regardless of assigned treatment group. The post hoc efficacy analyses included outcomes of
almotriptan treatment compared with placebo treatment for all
migraines in patients with a menstrual record.
RESULTS: Of the 275 women in the AEGIS intent-to-treat population, 190 (69.1%; 97
almotriptan, 93 placebo; aged 18-54 years) reported > or = 1 menses during the trial. Of the 506
migraines reported by these patients, 95 (18.8%) occurred +/-2 days of the first day of menstrual flow and were defined as MRM.
Aura was associated with 11.7% of MRM and 15.0% of nonMRM.
Allodynia-associated symptoms were present with 62.8% of MRM and 57.0% of nonMRM. Prior to treatment, 19.1% of MRM were associated with normal functional ability, 68.1% with disturbed functional ability, and 12.8% required
bed rest compared with 18.9%, 68.8%, and 12.3%, respectively, of nonMRM. Pretreatment
pain intensity was mild in 40.0%, moderate in 47.4%, and severe in 12.6% of MRM compared with 43.6%, 47.2%, and 9.2%, respectively, of nonMRM.
Almotriptan treatment efficacy outcomes for MRM vs nonMRM, respectively, were: 2-hour
pain relief, 77.4% vs 68.3%; 2-hour
pain free, 35.4% vs 35.9%; and sustained
pain free, 22.9% vs 23.8%.
Almotriptan was similarly effective in relieving
migraine-associated symptoms and improving functional disability associated with both MRM and nonMRM.
CONCLUSIONS: Prior to treatment, the presence of
migraine-associated characteristics including
aura,
allodynia-associated symptoms,
photophobia,
phonophobia, and
nausea were similar for both MRM and nonMRM attacks. The pretreatment levels of
pain intensity and functional disability were likewise similar across the
migraine subtypes.
Almotriptan was equally effective in the treatment of both MRM and nonMRM attacks and was associated with an adverse event profile that was similar to placebo treatment.