Almotriptan: a review of pharmacology, clinical efficacy, and tolerability.

OBJECTIVE

This article summarizes preclinical and clinical data for almotriptan.

METHODS

Almotriptan has been evaluated in more than 3,500 acute migraine patients in phase 2 and 3 double-blind, randomized trials and in 1,500 patients in long-term open-label trials.

RESULTS

Controlled clinical trials show that almotriptan 12.5 mg is significantly more effective than placebo. These results are observed across different endpoints examined, including pain relief at 2 hours, pain-free outcome at 2 hours, recurrence rate, use of escape medication, and sustained pain-free outcome. The onset of pain relief is observed as early as 30 minutes after administration. Results from a multiple-attack study show that almotriptan maintains a consistency of response across 3 attacks, and results from long-term studies confirm that patients continue to respond to almotriptan for up to 1 year. Results from 2 comparative studies show that almotriptan 12.5 mg has comparable efficacy to sumatriptan 50 or 100 mg, but almotriptan has a superior tolerability profile. Early use of almotriptan results in a higher proportion of patients achieving pain relief or complete freedom from pain.

CONCLUSIONS

Because almotriptan has a tolerability profile comparable to that of placebo, it may be more acceptable for early administration. The incidence of treatment-related adverse events with almotriptan is comparable to that of placebo and significantly lower than recorded with sumatriptan. In addition, almotriptan has a low incidence of chest symptoms, an adverse event associated with triptan use. Because of its comparable efficacy and superior tolerability profile, almotriptan offers a potential improvement over existing triptans for the treatment of acute migraine.