Efficacy of naratriptan tablets in the acute treatment of migraine: A dose-ranging study

Objective: This study sought to compare the efficacy of several doses of na ratriptan tablets with that of sumatriptan tablets and placebo in the acute treatment of a single migraine attack. Methods: This was a randomized, double-blind, placebo-controlled, parallel- group, dose-ranging study. Patients received either naratriptan tablets (1, 2.5, 5, 7.5, or 10 mg), sumatriptan tablets (100 mg), or placebo. Results: A total of 643 patients took part in the study. Two hours after do sing, headache relief was reported by significantly more patients treated w ith any dose of naratriptan (52%-69%) or sumatriptan (60%) than with placeb o (31%) (P < 0.05). Four hours after dosing, headache relief was reported b y significantly more patients treated with any dose of naratriptan (63%-80% ) or sumatriptan (80%) than with placebo (39%) and by significantly more pa tients treated with sumatriptan 100 mg (80%) than with naratriptan 1 mg (64 %), 2.5 mg (63%), or 5 mg (65%) (P < 0.05). Twenty-four-hour overall effica cy (headache relief maintained through 24 hours postdose with no worsening, no use of rescue medication, and no recurrence) was reported by more patie nts treated with any dose of naratriptan (39%-58%) or sumatriptan (44%) tha n with placebo (22%). Headache recurrence was reported in 17% to 32% of nar atriptan-treated patients, 44% of sumatriptan-treated patients, and 36% of placebo recipients. The overall incidence of adverse events was similar in patients treated with naratriptan I mg (20%), naratriptan 2.5 mg (21%), and placebo (23%). For naratriptan 5, 7.5, and 10 mg, the incidence of adverse events was 32%, 37%, and 35%, respectively and for sumatriptan 100 mg it w as 26%. Conclusions: Our results suggest that the 2.5-mg dose of naratriptan tablet s offers the optimal efficacy-to-tolerability ratio at the dose range betwe en 1 and 10 mg. Although naratriptan 2.5 mg was less effective than sumatri ptan 100 mg at 4 hours after dosing, the 2 medications showed similar effic acy at 24 hours.