Almotriptan is an Effective and Well-Tolerated Treatment for Migraine Pain: Results of A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Abstract

Almotriptan is a novel and specific serotonin 5-HT1B/1D agonist for the acute treatment of migraine. This randomized, single-dose, double-blind, multicentre, study assessed the efficacy and safety of oral almotriptan (12.5 mg and 25 mg) in patients with migraine, and compared it with the standard treatment (sumatriptan 100 mg) and placebo. A total of 668 patients treated one migraine attack of moderate or severe intensity with study medication. The primary efficacy assessment was migraine pain relief, improvement from severe or moderate pain to mild or no pain, at 2 h after treatment. Response rates, stratified for variation in baseline pain levels, for both almotriptan doses were equivalent to sumatriptan and significantly better than placebo. Other efficacy assessments confirmed the equivalence of the almotriptan groups with the sumatriptan group. Almotriptan 12.5 mg was as well tolerated as placebo (P=0.493) and significantly better tolerated than sumatriptan (P<0.001), in terms of the overall incidence of adverse events. There was no statistically significant difference in the incidence of adverse events between almotriptan 25 mg and sumatriptan 100 mg (P=0.376). The results from this large clinical study indicate that the new, specific 5-HT1B/1D agonist, almotriptan, is an effective and well-tolerated treatment for migraine pain.

Sumatriptan (Oral Route of Administration) for Acute Migraine Attacks in Adults

“…Sumatriptan 100 mg versus placebo-Of the 12 studies originally analysed comparing sumatriptan 50 mg with placebo for incidence of any adverse event within 24 hours, four offered participants a second dose of study medication and did not report adverse events according to the number of doses received (Dowson 2002;Ensink 1991;Goadsby 2000;Pfaffenrath 1998). Removing these studies from the analysis made no significant difference to the calculated relative risk of treatment versus placebo (analysis not shown).…”

“…• Sumatriptan 100 mg versus placebo Dahlof 1991;DKSMSG 1999;Dodick 2002;Dowson 2002;Ensink 1991;Geraud 2000;Goadsby 1991;Goadsby 2000;Havanka 2000;Jelinski 2006;Kaniecki 2006;Mathew 2003;Myllyla 1998;Nappi 1994;Nett 2003;Patten 1991;Pfaffenrath 1998;Pini 1995;Sandrini 2002;Sargent 1995;Sheftell 2005 • Sumatriptan 100 mg versus diclofenac potassium 50 mg (DKSMSG 1999).…”

“…Three studies (1027 participants) provided data for the use of rescue medication up to four hours after initial dosing, in participants with moderate or severe baseline pain intensity (Dowson 2002;Goadsby 1991;Tfelt-Hansen 1998).…”

A new questionnaire for assessment of adverse events associated with triptans: methods of assessment influence the results. Preliminary results

“…There are methodological differences even when the unprompted method is used. In some trials, patients record the side effects in a headache diary [15], while in others the collection is also complemented by communication with the study coordinator [16]. Finally, some studies actively searched for the "incidence and nature of all serious adverse events (at any time before or after administration)" [17].…”

Understanding clinical trials in migraine

“…In one comparative RCT [26] and in a meta-analysis [18,19] 12.5 mg almotriptan caused no more AEs than placebo and less AEs than 100 mg sumatriptan. In the comparative RCT [26] and in the meta-analysis [18,19] 12.5 mg almotriptan was comparable to 100 mg sumatriptan and apparently better for sustained freedom from pain in the metaanalysis [18,19]; but in one large comparative RCT [27] 50 mg sumatriptan (25%) was superior to 12.5 mg almotriptan (18%) for freedom from pain after 2 h and also better for sustained freedom from pain [28]. Pfizer (eletriptan) went for more efficacy, and in one systematic review of 3 comparative RCTs 40 mg sumatriptan was superior to 100 mg sumatriptan [29].…”