Sumatriptan for the Range of Headaches in Migraine Sufferers: Results of the Spectrum Study

Background.—Migraineurs experience a spectrum of headaches: migraine, migrainous, and episodic tension‐type 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 = 1110), migrainous ( n = 103), and tension‐type ( n = 363). Sumatriptan was superior to placebo for headache response 4 hours postdose (primary endpoint) across all headache types (migraine, 66% versus 48%; P < .001; migrainous, 71% versus 39%; P < .01; tension‐type, 78% versus 50%, P < .001). Sumatriptan was also superior to placebo for pain‐free response 4 hours postdose for migraine (41% versus 24%, P < .001) and tension‐type headaches (56% versus 36%, P = .001). Sumatriptan provided superior pain‐free response 2 hours postdose for migraine (18% versus 7%, P < .0001) and tension‐type headache (28% versus 14%, P = .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.