[Evaluation of the efficacy of oral sumatriptan in the management of migraine attacks. Clinical results].

This italian multicentre, double blind, parallel groups study compared the efficacy, safety and tolerability of oral sumatriptan, given as new film-coated tablet, with placebo in the acute treatment of migraine. 88 Patients received placebo and 162 patients received sumatriptan 100 mg (plus an optional dose 2 h later if the headache persisted plus a further optional dose for recurrence within 24 h). Sumatriptan was significantly more effective than placebo at releiving headache at 2 h (51% versus 31%, P = 0.003) and 4 h (71% versus 35%, P < 0.001). Fewer sumatriptan-treated patients required a second dose compared with placebo-treated patients (49% versus 74%, P < 0.001). Sumatriptan was more effective than placebo at relieving nausea, vomiting and photophobia/phonophobia. Few patients were evaluable for treatment of headache recurrence, and statistical analysis was not possible. More sumatriptan-treated patients than placebo-treated patients reported adverse events (29% versus 16%) but the difference was not statistically significant. More of these events were mild to moderate in severity, of short duration and resolved without treatment. Sumatriptan had no clinically significant effect on blood pressure, heart rate, electrocardiogram or laboratory test results. It is concluded that oral sumatriptan 100 mg, given as a film-coated, tablet, provides an effective and well-tolerated acute treatment for migraine.