Tolerability and efficacy of naratriptan tablets in the acute treatment ofmigraine attacks for 1 year

Objective and design: This open-label study was conducted to evaluate the t olerability and efficacy of the 5HT(1) agonist naratriptan with repeated us e in the acute treatment of migraine attacks for 1 year. Four hundred and s eventeen (417) migraine patients treated 15 301 migraine attacks over the c ourse of the study. Results: The results show that 84% of attacks treated w ith a single 2.5 mg dose of naratriptan were not associated with the occurr ence of an adverse event. The percentage of attacks associated with an adve rse event did not increase with number of doses used to treat a given attac k (1 vs. 2) or duration of use (0-6 months vs. > 6-12 months). The only adv erse events experienced in > 2% of attacks throughout the 1-year study were nausea (3% of attacks), hyposalivation (2% of attacks), and drowsiness/sle epiness (2% of attacks). Headache relief 4 h post-dose was reported in a me dian 70% of moderate or severe attacks and a median 86% of mild attacks tre ated with naratriptan tablets 2.5 mg. The percentages of patients reporting headache relief did not diminish as a function of increased duration of tr eatment (0-6 months vs. > 6-12 months) or frequency of use (for > 36 vs. < 36 attacks). The mean number of tablets taken per attack was 1.2. A second naratriptan 2.5 mg tablet was taken for headache recurrence in a mean 16% ( median 8%) of attacks. Conclusion: The results of this study demonstrate th at naratriptan tablets 2.5 mg taken for acute migraine attacks over a 1-yea r period are well-tolerated and effective.