WESTPORT, CT (Reuters Health) – While sumatriptan is statistically better than 1.4 mg alniditan for attaining pain-free response at 2 hours, the difference is small and not clinically important, according to a report in the journal Cephalalgia.
Dr. H. C. Diener, of the University of Essen in Germany, and a multinational team conducted a double-blind phase III trial to compare the efficacy of alniditan and sumatriptan in patients with acute migraine. Of 924 patients treated, 157 received placebo, 309 received 1.4 mg alniditan, 141 received 1.8 mg alniditan, and 317 received 6 mg sumatriptan, all delivered by subcutaneous injection.
About 40% of placebo-treated patients reported response to treatment, which was defined as a reduction of headache severity from moderate or severe before treatment to mild or absent at 2 hours. In comparison, 80.9% of patients who received 1.4 mg alniditan responded to treatment, as did 85.1% of those treated with 1.8 mg alniditan, and 87.1% of those who used sumatriptan.
The investigators determined that the response rate was significantly higher (p < 0.001) with 1.4 mg alniditan than with placebo. However, the response rate was significantly higher (p = 0.036) with sumatriptan than with 1.4 mg alniditan.
Fourteen percent of patients treated with placebo were free of pain at 2 hours, compared with 56.3% of those treated with 1.4 mg alniditan, 61.7% of those treated with 1.8 mg alniditan, and 65.9% of those treated with sumatriptan. Again, alniditan 1.4 mg was significantly better (p < 0.001) than placebo, the researchers report, while sumatriptan was significantly better (p = 0.015) than 1.4 mg alniditan.
"The safety profile of sumatriptan was similar to that of sumatriptan in this trial," Dr. Diener's group reports.