Early Intervention With Almotriptan: Results of the AEGIS Trial (AXERT^® Early Migraine Intervention Study)

Abstract

Treatment with almotriptan within 1 hour of migraine onset resulted in significantly better clinical outcomes than placebo and tolerability similar to placebo. Acute medications, such as almotriptan, that are both effective and well tolerated may encourage patients to access acute treatment earlier.

Almotriptan Malate: Early Treatment in Acute Migraine

“…6,11 The tolerability is similar in these early design treatment trials to previous almotriptan trials. [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.…”

“…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.…”

“…All of these were considered unrelated to almotriptan or placebo treatment. 13 Chest pain, chest tightness, and other cardiac related adverse events were only detailed in two of the four studies. 12,13 The incidence of chest pain (0.4%) and chest tightness (0.1%) were low in a study assessing early versus late treatment.…”

“…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.…”