Almotriptan in the treatment of migraine attacks in clinical practice:: results of the TEA 2000 observational study

Background: Almotriptan, the most recent drug of the triptan family, has shown good efficacy and tolerability profile in clinical trials. Objective: To assess almotriptan's tolerability and effectiveness in the setting of routine clinical practice. Patients and methods: 1,643 patients diagnosed of migraine according to IHS criteria were recruited by 3 17 neurologists in the TEA 2000 study. Patients were instructed to report data on migraine attacks in a diary for a three months follow-up period. Data from 4,253 migraine attacks were obtained. Results: The incidence of adverse events was 0.02 per migraine attack (3,9% of patients). Subjective clinical improvement after 30 minutes (33.2 y 37.1%), pain improvement after 2 hours (65.5% and 70.2%), pain free response after 2 hours (26.6% and 29.2%), recurrence between 2 and 24 hours (21.2% and 17%) and a complete response by 24 hours (18.6% and 22.9%) were found. These results were obtained in both "intention to treat" and "per protocol" analyses, being even much better when only low pain intensity attacks were considered. Conclusions: The TEA 2000 study results demonstrate good effectiveness and excellent tolerability profile of almotriptan 12.5 mg in the daily clinical neurological practice. The results of this study confirm those obtained in clinical trials carried out before almotriptan was introduced into the market and that it is a good therapeutic choice for the symptomatic treatment for migraine attacks.