Oral sumatriptan for the acute treatment of migraine: evaluation of three dosage strengths.

Abstract

This randomized, double-blind, parallel-group, placebo-controlled study evaluated the efficacy and tolerability of oral sumatriptan (Imitrex tablets) in 259 migraineurs. In the clinic, patients received oral sumatriptan 25 mg, 50 mg, or 100 mg, or placebo for the treatment of a migraine attack. The results indicate that by 2 hours post-dose, 50 to 56% of patients treated with any of the three doses, compared with 26% of patients treated with placebo, achieved relief of headache (p < 0.05 for each sumatriptan group vs placebo). By 4 hours postdose, 68 to 71% of sumatriptan-treated patients, compared with 38% of placebo-treated patients, achieved relief of headache (p < 0.05 for each sumatriptan group vs placebo). Oral sumatriptan was similarly effective at relieving nausea and photophobia and at reducing clinical disability. The pattern and incidence of adverse events did not differ between treatment groups. All doses--25 mg, 50 mg, and 100 mg--of sumatriptan were effective and generally well tolerated. Dosing should be individualized according to the needs of the patient.