Sumatriptan nasal spray: a dose-ranging study in the acute treatment of migraine.

This multicentre, randomized, double-blind, placebo-controlled, parallel group dose-ranging study compared the efficacy and tolerability of four doses of sumatriptan nasal spray (2.5, 5, 10 and 20 mg) with a placebo, in the acute treatment of a single migraine attack. In total, 544 patients received the study medication as a single spray in one nostril, to treat a single migraine attack in the clinic. Efficacy assessments included the measurement of headache severity, clinical disability, and the presence/absence of associated symptoms. The incidence of headache recurrence was also assessed. The three highest doses of sumatriptan (5 mg 49%, 10 mg 46%, 20 mg 64%) were significantly better than the placebo (25%) at providing headache relief (moderate or severe headache improving to mild or none) 120 min after treatment (P

A double-blind placebo-controlled study assessing the efficacy and tolerability of 50 mg sumatriptan tablets in the acute treatment of migraine. Sumatriptan Tablets S2CM07 Study Group.

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 studied than the 100 mg dose. METHODS: This was a double-blind, parallel-group study (Glaxo Wellcome protocol number S2CM07) comparing the efficacy and safety of sumatriptan 50 mg tablets with placebo in the acute treatment of migraine. Patients treated three migraine attacks with study medication; a second, 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 proportion of patients who had obtained complete or almost complete headache relief at 4 h after dosing. RESULTS: For all attacks, a significantly greater proportion of patients experienced headache relief at 4 h with sumatriptan 50 mg tablets than with placebo (59% to 62% versus 32% to 42%; P = 0.005). The 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 events with sumatriptan was similar to that with placebo, and there was no increase in adverse events associated with use of a second dose to treat recurrence. CONCLUSIONS: Sumatriptan 50 mg tablets are well tolerated and efficacious in relieving migraine headache.

Patient preference for oral sumatriptan 25 mg, 50 mg, or 100 mg in the acute treatment of migraine: a double-blind, randomized, crossover study. Sumatriptan Tablets S2CM11 Study Group.

BACKGROUND: Dosing recommendations for oral sumatriptan have ranged from 25 mg to 100 mg. Patient dose preferences are clinically relevant (perhaps moreso than traditional efficacy endpoints) and deserve study. METHODS: A multinational randomized double-blind crossover study was conducted over 18 weeks to assess patient dose preference, efficacy, and tolerability for oral sumatriptan (25 mg, 50 mg, and 100 mg) in the acute treatment of migraine; 257 patients treated three attacks, using a different dose for each. RESULTS: The 100 mg dose was preferred by 35% of patients, 31% the 50 mg dose, and 25% the 25 mg dose. Efficacy and speed of action were the two main reasons given for preferring the higher doses. Compared with the 25 mg dose, the 100 mg and 50 mg doses were significantly more likely to provide headache relief at 2, 3, and 4 h after dosing and complete headache resolution at 3 and 4 h after dosing (P < 0.027). Recurrence rates were similar for the three doses, ranging from 33% to 38%, though the median time to recurrence increased with dose, from 8.5 to 11.8 h. The 25 mg, 50 mg, and 100 mg doses were all well tolerated, with adverse event incidences of 19%, 21%, and 30%, respectively. CONCLUSIONS: Patients preferred the 50 mg and 100 mg doses of oral sumatriptan to the 25 mg dose, and the higher doses were more effective against migraine; however, the 25 mg and 50 mg doses were better tolerated than the 100 mg dose. Though the 50 mg dose probably has the best effectiveness-to-tolerability ratio, some patients clearly prefer a higher dose.

Patient-selected dosing in a six-month open-label study evaluating oral sumatriptan in the acute treatment of migraine. Sumatriptan Tablets S2CM10 Study Group.

BACKGROUND: Dosing recommendations for oral sumatriptan as acute treatment for migraine have ranged from 25 mg to 100 mg. Patient dose preferences have not been studied in a setting mimicking clinical practice. METHODS: In an open-label study evaluating patient acceptance and the relative efficacy and safety of 25 mg, 50 mg, and 100 mg doses of oral sumatriptan over a period of six months, 338 patients treated three migraine attacks with 50 mg sumatriptan and then were allowed to double or halve the dose. After treating another three attacks, they were again allowed to adjust the dose by one level. RESULTS: After migraine attack 3, 37% of patients chose to continue with the 50 mg dose, 50% increased the dose to 100 mg, and 12% decreased it to 25 mg. After attack 6, 8%, 33%, and 58% of patients chose the 25 mg, 50 mg, and 100 mg doses, respectively; only 3% of those taking the 100 mg dose chose to reduce it. Overall, the mean percentages of attacks per patient in which headache relief had been obtained 4 h after dosing were 71%, 71%, and 80% for the 25 mg, 50 mg, and 100 mg doses, respectively. Patients who decreased the dose to 25 mg after attack 3 experienced decreases both in adverse events and percentage of attacks with headache relief, whereas in those who increased the dose to 100 mg, likelihood of headache relief increased but the incidence of adverse events did not. CONCLUSIONS: More patients chose the 50 mg or 100 mg dose than the 25 mg dose. All three doses had similar efficacy and tolerability.