Efficacy of almotriptan 12.5 mg in achieving migraine-related composite endpoints: a double-blind, randomized, placebo-controlled study in patients with previous poor response to sumatriptan 50 mg

Background: Triptans are not identical and migraine sufferers respond differently to different triptans. Few studies have evaluated the efficacy of switching triptans in migraine patients who have shown poor response to another agent. Objective: To investigate the efficacy and tolerability of almotriptan 12.5 mg in patents who did not achieve 2-h pain relief with sumatriptan 50 mg. Methods:This double-blind, placebo-controlled study recruited patients with IHS-defined migraine and at least 2 previous unsatisfactory responses to sumatriptan. Those who did not achieve pain relief (moderate or severe pain decreasing to mild or no pain) 2 h after taking oral sumatriptan 50 mg on an open-label basis for the treatment of their first migraine attack during this trial (Attack 1) were randomized to receive either oral almotriptan 12.5 mg or placebo for the treatment of their next migraine attack (Attack 2). Results: Of 302 patients receiving sumatriptan 50 mg for the treatment of their first migraine attack, 221 (73%) did not achieve 2-h pain relief and were randomized to almotriptan 12.5 mg or placebo for the treatment of Attack 2. The majority (70%) of randomized patients treating their headache in Attack 2 reported severe pain at baseline characterizing this as a difficult-to-treat population. In the intent-to-treat population (n = 198), significantly more patients in the almotriptan group compared with the placebo group achieved 2-h complete relief (free from pain and migraine-associated symptoms) at 2 h (17.1% vs. 4.4%; p < 0.05) and sustained pain free (20.9% vs. 9.0%; p < 0.05). Adverse events of mild-to-moderate intensity occurred in 7.1% of patients in the almotriptan group compared to 5.1% in the placebo group (not statistically different). Conclusion: Almotriptan is more effective than placebo and similarly well-tolerated for the acute treatment of migraine in patients who responded poorly to oral sumatriptan.