Rapid responders to frovatriptan in acute migraine treatment: results from a long-term, open-label study.

BACKGROUND: The chronic nature of migraine and the reliance on acute treatment constitute the basis of the present long-term, open-label study. OBJECTIVES: First, assessment of the tolerability and safety of frovatriptan, 2.5-7.5 mg taken orally over 24 hours, for the acute treatment of migraine, repeatedly over a 12-month period. Second, assessment of the efficacy and tolerability of a second, double-blind dose of 2.5-mg frovatriptan, compared with placebo, for nonresponse at 2 hours after treatment of moderate or severe headache with 2.5-mg frovatriptan. RESULTS: With regard to the first attack treated, 173 (36%) of the 486 subjects in the study did not take a second dose at 2 hours for nonresponse. At 2 hours and 4 hours, these "rapid responders" experienced a decrease in headache intensity from moderate or severe to mild or no pain in 84% and 98%, respectively ("headache response"). Six percent of them experienced recurrence of moderate or severe headache within 24 hours following a response at 4 hours and 12% took rescue medication. The response, measured in terms of median time to "complete migraine relief," was maintained over 30 subsequent migraine attacks, treated from attack 2 onwards over the course of 12 months. CONCLUSION: Frovatriptan provides a remarkably fast and high headache response in a subgroup of more than one-third of migraineurs, with a very low 24-hour headache recurrence and low rescue medication intake.