OBJECTIVES: To investigate the efficacy of a second subcutaneous dose of 6 mg sumatriptan in the treatment of recurrence of headache after successful treatment of a migraine attack with an initial 6 mg dose. METHODS: In a prospective, randomised, placebo controlled, double blind, parallel group study, 803 patients were treated for one to three migraine attacks with severe or moderate headache with a subcutaneous injection of 6 mg sumatriptan. Any subsequent recurrence of migraine headache was treated with a randomised second injection of sumatriptan or placebo. Recurrence was defined as a headache of moderate or severe intensity occurring 1-24 hours after the initial dose in a patient whose headache had been relieved by sumatriptan (reduction of headache severity from severe or moderate to mild or none after one hour). RESULTS: Headache recurrence was reported by 10%-15% of patients. At each attack, 6 mg sumatriptan given subcutaneously was significantly (P < 0.0005) more effective than placebo at relieving recurrent headache after one hour (84%-93% v 31%-50% of patients); 76%-83% of patients reported headache relief one hour after the initial dose of sumatriptan. Sumatriptan was generally well tolerated. CONCLUSIONS: Up to 15% of patients with migraine experience significant recurrence of headache after successful treatment with subcutaneous sumatriptan, and this recurrence is effectively treated by a further dose of subcutaneous sumatriptan.
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