A double-blind placebo-controlled study assessing the efficacy and tolerability of 50 mg sumatriptan tablets in the acute treatment of migraine

Background: Oral sumatriptan 50 mg has been found to have good efficacy and tolerability in the acute treatment of migraine but has been less well stu died than the 100 mg dose. Methods: This was a double-blind, parallel-group study (Glaxo Wellcome protocol number S2CM07) comparing the efficacy and s afety of sumatriptan 50 mg tablets with placebo in the acute treatment of m igraine. Patients treated three migraine attacks with study medication; a s econd, optional dose was available for treating recurrent headache. Of the 560 patients randomized, 485 treated at least one attack, 411 at least two attacks, and 362 three attacks. The primary efficacy measure was the propor tion of patients who had obtained complete or almost complete headache reli ef at 4 h after dosing. Results: For all attacks, a significantly greater p roportion of patients experienced headache relief at 4 h with sumatriptan 5 0 mg tablets than with placebo (59% to 62% versus 32% to 42%; P = 0.005). T he same was true at 3 h across all attacks, and at 2 h for attacks 1 and 2 (49% versus 23% and 45% versus 29%, respectively. Although sumatriptan and placebo were associated with similar incidences of recurrence, sumatriptan was associated with a longer time to recurrence. The incidence of adverse e vents with sumatriptan was similar to that with placebo and there was no in crease in adverse events associated with use of a second dose to treat recu rrence. Conclusions: Sumatriptan 50 mg tablets are well tolerated and effic acious in relieving migraine headache.