Subcutaneous sumatriptan for treatment of acute migraine in patients admitted to the emergency department: a multicenter study.

STUDY OBJECTIVE

To assess the efficacy of SC sumatriptan injection versus placebo in the treatment of acute migraine in ED patients and that of open-label 100 mg sumatriptan PO tablets for recurrent migraine.

DESIGN

Randomized, double-blind, placebo-controlled, multi-center trial.

SETTING

Twelve EDs in the United States.

PARTICIPANTS

Adult patients presenting to the ED from September 1992 through April 1993 with a diagnosis of migraine as determined by International Headache Society criteria. Patients were randomized to receive 6 mg sumatriptan SC or placebo. Patients were monitored for improvement in headache severity using a four-point scale and for time to meaningful relief using a stopwatch. The time to discharge from the ED was recorded. An open-label 100 mg sumatriptan PO tablet was given to all patients on discharge from the ED for use at home if the headache recurred within 24 hours.

RESULTS

One hundred thirty-six patients were enrolled. Seventy-five percent of patients treated with sumatriptan achieved meaningful relief compared with 35% treated with placebo (P < .001). The median time to meaningful relief was 34 minutes in the group that received sumatriptan. Seventy percent of patients in the sumatriptan group versus 35% in the placebo group reported mild or no pain at discharge (P < .001). Migraine-associated symptoms such as nausea, photophobia, and phonophobia were significantly reduced in the sumatriptan group (P < .005). The median time to discharge from the ED was shorter for the sumatriptan group than for the placebo group (60 versus 96 minutes, respectively; P = .001). At baseline, 15% of patients in the sumatriptan group and 19% of patients in the placebo group reported mild or no clinical disability. At the time of discharge, patients with mild or no disability increased to 75% in the sumatriptan group compared with 44% in the placebo group (P = .001). Fifty-seven of 92 patients (62%) with mild or no pain at discharge took open-label oral sumatriptan for headache recurrence, and 37 (65%) experienced meaningful relief within 2 hours. Median time to meaningful relief after oral sumatriptan was 65 minutes.

CONCLUSION

Sumatriptan (6 mg SC) is effective in treating acute migraine in the ED. Oral sumatriptan (100 mg) is effective in treating headache recurrence within 24 hours.