Comparison of naratriptan and sumatriptan in recurrence-prone migraine patients

Objective: This randomized, double-blind, crossover study was undertaken to compare the incidence of headache recurrence after treatment with naratrip tan or sumatriptan in migraine patients with a history of frequent headache recurrence (recurrence in greater than or equal to 50% of successfully tre ated attacks). Background: Although the selective 5-hydroxytryptamine(1) (5-HT1) agonist s umatriptan is effective and well tolerated for acute treatment of migraine in most patients, headache recurrence within 24 hours of initial successful treatment with sumatriptan and other medications has been reported in simi lar to 35% of patients. The novel 5-HT1 agonist naratriptan possesses pharm acologic and pharmacokinetic characteristics that may address the issue of headache recurrence. Methods: Men and women aged 18 to 65 years with a greater than or equal to 1-year history of migraine with or without aura were randomly assigned to t reat 1 moderate or severe migraine attack in a nonclinical setting with one 2.5-mg naratriptan tablet and I attack with one 100-mg sumatriptan tablet. A pain-free interval of greater than or equal to 24 hours was required bet ween attacks. At 4 hours, patients not using rescue medication and experien cing headache recurrence could take a second, identical dose of study medic ation to treat recurrence. No more than 2 tablets of study medication were permitted in any 24-hour period. Results: A total of 253 patients treated greater than or equal to 1 migrain e attack and were included in the safety analysis; the 225 patients who tre ated both attacks were included in the efficacy analysis. Of the 164 naratr iptan-treated and 181 sumatriptan-treated patients experiencing headache re lief after greater than or equal to 1 attack, headache recurrence 4 to 24 h ours after treatment was reported by 74 naratriptan-treated patients (45%) and 101 sumatriptan-treated patients (57%; not statistically significant). (One naratriptan- and 3 sumatriptan-treated patients who experienced headac he relief did not record recurrence status and were not included in the den ominator for the percentage calculation.) In a subset of patients experienc ing headache relief after 2 attacks, headache recurrence 4 to 24 hours afte r initial dosing was reported by 55 naratriptan- and 77 sumatriptan-treated patients (41% and 57%, respectively; P = 0.005). The overall incidence of adverse events was 22% after treatment with naratriptan and 33% after treat ment with sumatriptan. This incidence did not increase after use of a secon d dose of naratriptan (20%) or sumatriptan (31%). Conclusion: These data suggest that naratriptan is a long-acting and well-t olerated addition to currently available medications for the treatment of a cute migraine.