February 1996

A Double-blind Study of Subcutaneous Dihydroergotamine vs Subcutaneous Sumatriptan in the Treatment of Acute Migraine

Author Affiliations

From the Palm Beach Headache Center, West Palm Beach, Fla (Dr Winner), the Departments of Neurology, Keesler Medical Center, Keesler Air Force Base, Miss (Dr Ricalde), and Lackland Medical Center, Lackland Air Force Base, Tex (Dr Le Force), the Michigan Head Pain and Neurological Institute, Ann Arbor (Dr Saper), and Sandoz Pharmaceuticals, East Hanover, NJ (Dr Margul). Dr Le Force is now in private practice, San Antonio, Tex, and Dr Ricalde is at the Department of Neurology, Tulane University Medical School, New Orleans, La. For a list of the other participants in the study, see box on page 184.

Arch Neurol. 1996;53(2):180-184. doi:10.1001/archneur.1996.00550020092020

Objective:  To assess the efficacy and tolerability of subcutaneous dihydroergotamine mesylate (DHE-45) vs subcutaneous sumatriptan succinate (Imitrex) for the treatment of acute migraine with or without aura.

Design:  Double-blind, randomized trial with parallel treatment arms.

Setting:  Clinics and private neurology practices.

Subjects:  Patients of either sex, with migraine with or without aura, between the ages of 18 and 65 years.

Interventions:  Patients with moderate or severe head pain were randomized to receive either 1 mg of subcutaneous dihydroergotamine mesylate or 6 mg of subcutaneous sumatriptan succinate. Patients rated head pain, functional ability, nausea, and vomiting at baseline and at 0.5, 1, 2,4, and 24 hours after the injection. Presence or absence of headache at 3 hours was calculated from collected data. If pain persisted after 2 hours, a second injection of the same study medication was allowed, and self-ratings were repeated 30 and 60 minutes later. Follow-up data were collected at 24 hours.

Main Outcome Measures:  Relief of head pain and recurrence of successfully treated headache.

Results:  There were 295 evaluable patients. At 2 hours, 73.1% of the patients treated with dihydroergotamine and 85.3% of those treated with sumatriptan had relief (P=.002). There was no statistical difference in headache relief between the groups at 3 or 4 hours. Headache relief was achieved by 85.5% of those treated with dihydroergotamine and by 83.3% of those treated with sumatriptan by 4 hours. By 24 hours 89.7% of dihydroergotamine-treated patients and 76.7% of sumatriptan-treated patients had relief (P=.004). Headache recurred within 24 hours after treatment in 45% of the sumatriptan-treated patients and in 17.7% of the dihydroergotamine-treated patients (P≤.001).

Conclusions:  Both sumatriptan and dihydroergotamine were effective in aborting migraine headaches. Headache recurrence was two and a half times as likely with sumatriptan as with dihydroergotamine.