Objective.-To evaluate the effectiveness of sumatriptan, 50-mg tablets, versus placebo for early intervention while head pain was mild in patients with disabling migraine.Methods.-A post hoc analysis was performed in a subgroup of patients from a large, randomized, placebocontrolled study of patients with disabling headache who treated while pain was mild. Pain-free response 2 and 4 hours postdose, headache recurrence, and safety were examined. Significance tests were performed only for the first-treated attacks.Results.-Twenty-six patients with disabling headache treated 46 mild and 166 moderate or severe headaches. For the first-treated headaches while pain was mild, pain-free rates were significantly higher for sumatriptan than placebo 4 hours postdose (78% versus 0%, P ϭ .02), but not 2 hours postdose (52% versus 0%, P ϭ .22). Across all headaches treated while pain was mild, pain-free responses were higher for sumatriptan than placebo 4 hours (85% versus 17%) and 2 hours (50% versus 0%) postdose compared with placebo. When the same patients treated headaches while pain was moderate or severe, pain-free rates were lower than that reported for treatment during mild pain. There was a trend toward lower headache recurrence in headaches treated while pain was mild compared with moderate or severe pain (13% versus 18%). No drug-related adverse events were reported in the headaches treated while pain was mild.Conclusions.-Patients with disabling migraine may benefit from early intervention with sumatriptan, 50 mg, while pain is mild.
Background.-Migraineurs experience a spectrum of headaches: migraine, migrainous, and episodic tensiontype as defined by the International Headache Society (IHS).Objective.-To evaluate the effectiveness of sumatriptan, 50-mg tablets, in treating the spectrum of headaches in IHS-diagnosed migraineurs.Design/Methods.-Migraineurs with severe disability (Headache Impact Questionnaire score 250 or greater) were enrolled in a randomized, double-blind, placebo-controlled, crossover study. Patients treated up to 10 headaches with sumatriptan, 50 mg, or placebo (4:1). Headache features, recorded prior to treatment, were used to classify each headache using IHS criteria. Headache response (moderate or severe pain reduced to mild or no pain) and pain-free response were recorded at 2 and 4 hours postdose (primary endpoint). Because patients treated multiple attacks, statistical methods controlling for within-subject correlation were used.Results.-Two hundred forty-nine migraineurs treated 1576 moderate or severe headaches: migraine (n ϭ 1110), migrainous (n ϭ 103), and tension-type (n ϭ 363). Sumatriptan was superior to placebo for headache response 4 hours postdose (primary endpoint) across all headache types (migraine, 66% versus 48%; P Ͻ .001; migrainous, 71% versus 39%; P Ͻ .01; tension-type, 78% versus 50%, P Ͻ .001). Sumatriptan was also superior to placebo for pain-free response 4 hours postdose for migraine (41% versus 24%, P Ͻ .001) and tension-type headaches (56% versus 36%, P ϭ .001). Sumatriptan provided superior pain-free response 2 hours postdose for migraine (18% versus 7%, P Ͻ .0001) and tension-type headache (28% versus 14%, P ϭ .0005) compared with placebo.Conclusion.-Sumatriptan, 50-mg tablets, are effective for the full spectrum of headaches experienced by patients with disabling migraine due to a sumatriptan-responsive mechanism.
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