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Clinical Trial
. 1995 Apr;25(4):464-9.
doi: 10.1016/s0196-0644(95)70259-8.

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

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Clinical Trial

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

B E Akpunonu et al. Ann Emerg Med. .

Erratum in

  • Ann Emerg Med 1995 Jun;25(6):857

Abstract

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.

Comment in

  • Sumatriptan: a clinical standard?
    Stratton SJ. Stratton SJ. Ann Emerg Med. 1995 Apr;25(4):538-9. doi: 10.1016/s0196-0644(17)30479-1. Ann Emerg Med. 1995. PMID: 7710163 No abstract available.

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