RIZATRIPTAN (MAXALT) FOR THE ACUTE TREATMENT OF MIGRAINE AND MIGRAINERECURRENCE - A PLACEBO-CONTROLLED, OUTPATIENT STUDY

Rizatriptan is a novel 5-HT1B/1D agonist which Is rapidly absorbed aft er oral administration. The efficacy and tolerability of oral rizatrip tan (5 mg and 10 mg) were examined in this multicenter, double-blind, outpatient study of 1473 migraineurs which featured randomized, placeb o-controlled treatment of migraine recurrences. On experiencing modera te or severe migraine headaches, patients rated headache severity prio r to dosing and at 30-minute intervals for 2 hours after dosing. Onset of affect was seen as early as 30 minutes after dosing with rizatript an 10 mg. At 2 hours postdose, the percentage of patients with pain re lief was significantly higher after rizatriptan 5 mg (62%) or 10 mg (7 1%) compared with placebo (35%). Complete relief was also significantl y higher after rizatriptan 5 mg (33%) and 10 mg (42%) compared with pl acebo (10%). In patients experiencing headache recurrence after initia l benefit, further relief was obtained in 71% with rizatriptan 5 mg (p lacebo 54%) and in 82% with rizatriptan 10 mg (placebo 44%). Complete relief of recurrent headache was obtained in 36% with rizatriptan 5 mg , 49% with rizatriptan 10 mg, and 15% with placebo (P < 0.05). The mos t common drug-related adverse experiences were dizziness, somnolence, asthenia/fatigue, and nausea (the incidences of which were low and dos e related). There was no increase in the incidence of adverse experien ces after use of up to three doses of rizatriptan within 24 hours. We conclude that both doses of rizatriptan are effective and well tolerat ed in the acute treatment of migraine and migraine recurrence, with th e 10-mg dose preferred as it is more effective with a faster onset of action.