ABSTRACT
BACKGROUND: Sumatriptan is effective for the treatment of acute migraine. However, headache may recur in about 30% of patients within 24 hours of successful treatment. OBJECTIVE: To evaluate the efficacy of oral sumatriptan, 100 mg, in the treatment of headache recurring within 24 hours of achieving headache resolution with subcutaneous sumatriptan, 6 mg. STUDY DESIGN: Subcutaneous sumatriptan was administered for up to 12 migraine attacks in a randomized, double-blind, parallel-group study. Patients whose headache was completely resolved 90 minutes after subcutaneous dosing received either oral sumatriptan or placebo at the onset of recurrent headache. Patients whose headache was not completely resolved were offered rescue medication, including sumatriptan. Patients rated headache severity for 24 hours. SETTING: Fifteen US outpatient clinics. MAIN OUTCOME MEASURE: Percentage of patients with relief of recurrent headache and adverse events. RESULTS: Approximately 90% of patients achieved relief of headache (severe or moderate headache reduced to mild or no headache) by 90 minutes after unblinded subcutaneous administration of sumatriptan. Efficacy rates were at least 80% regardless of whether the headache fulfilled the International Headache Society criteria for migraine. About 64% of patients achieved complete relief. Oral sumatriptan, 100 mg, relieved moderate or severe recurrent headache within 4 hours in up to 81% of patients. Oral sumatriptan administered as rescue medication to patients not headache-free did not relieve persistent headache. The incidence, pattern, and severity of adverse events after combined subcutaneous and oral administration of sumatriptan were similar to those after subcutaneous administration alone. CONCLUSIONS: Oral sumatriptan was consistently effective in the treatment of headache recurrence.
