ORAL SUMATRIPTAN FOR THE LONG-TERM TREATMENT OF MIGRAINE - CLINICAL FINDINGS

This double-blind, placebo-controlled, crossover study of the acute tr eatment of migraine investigated the efficacy and tolerability of oral sumatriptan 100 mg (Imitrex) administered for up to nine attacks comp ared with placebo administered for up to three attacks. Patients were randomized to receive oral sumatriptan 100 mg or placebo on an outpati ent basis in a 3:1 ratio for three four-attack blocks. Headache relief 4 hours postdose was observed in 59 to 65% of patients after sumatrip tan treatment compared with 18 to 23% of patients after placebo treatm ent across three four-attack blocks (p < 0.005). For each block, oral sumatriptan 100 mg was also significantly more effective than placebo at relieving clinical disability and nausea and vomiting. Efficacy on all these measures was consistently maintained with repeated administr ation. Oral sumatriptan 100 mg was well tolerated, and repeated admini stration did not alter the pattern or severity of adverse events. Thes e data demonstrate that the efficacy and tolerability of oral sumatrip tan 100 mg was consistently maintained with repeated administration fo r up to nine separate migraine attacks.