A double-blind study of subcutaneous dihydroergotamine vs subcutaneous sumatriptan in the treatment of acute migraine
P. Winner, O. Ricalde, B. Le Force, J. Saper and B. Margul
Palm Beach Headache Center, Fla, USA.
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 < or = .001).
CONCLUSIONS: Both sumatriptan and dihydroergotamine were effective in
aborting migraine headaches. Headache recurrence was two and a half time as
likely with sumatriptan as with dihydroergotamine.