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Oral Sumatriptan for the Acute Treatment of
Probable Migraine: First Randomized, Controlled Study
Tepper SJ, Cady R, Dodick D, et al.
Posted: February 2006
Objective: To evaluate the efficacy and
tolerability of sumatriptan tablets in adults who meet International
Headache Society (IHS) criteria for probable migraine but who do not
meet IHS criteria for migraine with or without aura.
Background: Headache with some but not all of the
features of migraine meet criteria for probable migraine, a form
of migraine recognized by the HIS. Probable migraine attacks are
also prevalent and frequently underdiagnosed.
Methods: This was a randomized, multicenter, double-blind, placebo-controlled, parallel-group study. Adults
with a 1-year history of headaches that met 2004 HIS criteria for probable migraine without aura were
eligible for enrollment. All patients were triptan- and ergot-naive and had never been diagnosed with
migraine. Patients were randomized to receive sumatriptan 25, 50, or 100 mg. conventional tablets or
matching placebo and were instructed to treat a single moderate or severe probable migraine attack.
A post hoc analysis was conducted to evaluate the population of patients who achieved headache relief
sustained throughout the immediate posttreatment period. Patients who reported relief within 2 hours
and subsequently lost headache relief within 4 hours were considered nonresponders.
Results: At 2 hours, more patients treated with sumatriptan achieved headache relief, the primary efficacy
measure compared with placebo, but differences only approached statistical significance for 100 mg.
The 2-hour headache relief rate in the sumatriptan 25 or 50 mg. groups was not significantly different
than placebo. The time to use of rescue was significantly shorter in the placebo group compared with
the sumatriptan 100 mg. group. The time to use of rescue in the sumatriptan 25 or 50 mg. groups was
not significantly different than placebo. More patients treated with placebo lost headache relief
within 4 hours compared with patients treated with sumatriptan 25 mg., 50 mg., or 100 mg. A post hoc
analysis demonstrated that at 2 hours, headache relief sustained through 4 hours was achieved in 44%,
49%, and 57% of patients treated with sumatriptan 25, 50 and 100 mg. respectively, compared with 34%
of patients treated with placebo. All doses of sumatriptan were well tolerated and no serious adverse
events were reported.