Effect of Pain Intensity and Time to Administration on Responsiveness to Almotriptan: Results from AXERT^® 12.5 mg Time Versus Intensity Migraine Study (AIMS)

Abstract

Total headache duration was significantly shorter in the early treatment group compared to the standard treatment group. Considering time to treatment within a relatively early range of 1 hour or less, efficacy results when treating mild versus moderate pain were similar and both were associated with better outcomes than treatment of severe pain. When considering the prognostic variables of time to treatment and headache pain intensity (limited to moderate vs severe), both were independent predictors, with time to treatment a better predictor of headache duration and rescue medication use, and pain intensity a better predictor of 2-hour pain free and sustained pain free.

Almotriptan Malate: Early Treatment in Acute Migraine

“…[11][12][13][14][15] Adverse event rates are similar to placebo 13,16 and there was no significant difference in overall adverse event rates reported in those who treated the migraine headache early compared to late. 12,15 Only two of the four early treatment studies reported premature discontinuation rates. 12,13 (See Table 1) The first was a head to head comparison of early to standard treatment with almotriptan.…”

“…The most common adverse effects reported in these two early intervention trials were nausea, vomiting and somnolence. 12,13 Only two studies reported serious adverse events. 12,13 The first reported three patients experiencing serious adverse events.…”

“…12,13 Only two studies reported serious adverse events. 12,13 The first reported three patients experiencing serious adverse events. 12 One patient who did not take a dose of study drug died from a myocardial infarction while enrolled.…”

“…12,15 Only two of the four early treatment studies reported premature discontinuation rates. 12,13 (See Table 1) The first was a head to head comparison of early to standard treatment with almotriptan. The early group had 4.2% withdraw while the standard treatment group had 3.3% withdraw due to intolerable adverse effects.…”

“…The early group had 4.2% withdraw while the standard treatment group had 3.3% withdraw due to intolerable adverse effects. 12 The second trial was a placebo controlled trial with identical discontinuation rates between almotriptan and placebo (0.6%). The most common adverse effects reported in these two early intervention trials were nausea, vomiting and somnolence.…”