Subcutaneous Sumatriptan for Treatment of Acute Migraine in Patients Admitted to the Emergency Department: A Multicenter Study

Abstract

See related editorial, "Sumatriptan: A Clinical Standard?"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, multicenter 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. Patientswere 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. [Akpunonu BE, Mutgi AB, Federman DJ, Volinsky FG, Brickman K, Davis RL, Gilbert C, Asgharnejad M: Subcutaneous sumatriptan for treatment of acute migraine in patients admitted to the emergency department: A multicenter study. Ann Emerg Med April 1995;25:464-469.]