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

Presented at the Society for Academic Emergency Medicine Annual Meeting in San Francisco, California, May 1993.
https://doi.org/10.1016/S0196-0644(95)70259-8Get rights and content

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.]

Section snippets

INTRODUCTION

An estimated 1.6% to 2.5% of emergency department patients present with the chief complaint of headache. Migraine is the ultimate diagnosis in 4% to 22% of these patients.1, 2 Management of migraineurs in the ED requires the use of an effective drug that has an acceptable adverse-event profile and minimum or no abuse potential.

Medications commonly used in the EDs to treat migraine include narcotics, combination analgesics, tranquilizers, barbiturates, nonsteroidal anti-inflammatory drugs, ergot

MATERIALS AND METHODS

T his multicenter, randomized, double-blind, placebo-controlled study involved 12 US EDs. Patients were randomized in blocks of six with a 2:1 ratio of sumatriptan to placebo. Patients were enrolled from September 1992 through April 1993.

Patients 18 years of age or older who met the International Headache Society classification for migraine without aura (common) or for migraine with aura (classic) were eligible for participation.24 It was required that patients had a migraine headache history

RESULTS

One hundred thirty-six patients completed the study. Demographic characteristics and baseline migraine types are given in Table 1.Placebo and sumatriptan groups were comparable with respect to age, sex, ethnic origin, baseline blood pressure, and migraine type. The median duration of headache before the ED visit was 16 hours for the placebo group and 13 hours for the sumatriptan group (P =NS). Associated symptoms present at baseline (nausea, vomiting, photophobia, phonophobia) and the degree of

DISCUSSION

More than 11 million people in the United States have migraine headaches with moderate-to-severe disability.25 Extrapolated health care and labor loss ascribed to migraines range from $5.6 to $17.2 billion.26 Of patients presenting to EDs, 1.6% to 2% have headache as their chief complaint, with 4% to 22% complaining of migraine.1, 2 Headaches are associated with significant disability related to pain, nausea, vomiting, photophobia, phonophobia, and dehydration, including lost time from work.

CONCLUSION

Subcutaneous sumatriptan (6 mg) is effective in treating patients who present to the ED with an acute migraine and is convenient to administer. Compared with placebo, patients who received subcutaneous sumatriptan spent less time in the ED. Oral sumatriptan appears to be effective in relieving recurring migraine attacks. Further controlled clinical trials are warranted to confirm the efficacy of sumatriptan.

Acknowledgements

This study was supported by a grant from Glaxo Pharmaceuticals, Incorporated. The authors acknowledge Maureen Gilmore for her word processing assistance in preparing the manuscript.

The authors acknowledge the following investigators and members of the US Sumatriptan Research Group who contributed to the conception, conduct, and analysis of data and preparation of the manuscript.

Clinical Investigators: B Akpunonu, MD; A Mutgi, MD; D Federman, MD; C Brickman, MD; M Diamond, MD; F Frietag, DO; G

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    From the Departments of Internal Medicine* and Emergency Medicine, Medical College of Ohio, Toledo; and Glaxo, Incorporated, Research Institute, North Carolina.§

    ☆☆

    Address for reprints: Basil E Akpunonu, MD, Department of Internal Medicine and Emergency Department, Medical College of Ohio, 3000 Arlington Avenue, Toledo, Ohio 43699-0008, Fax 419-382-0354

    Reprint no. 47/1/63469

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