Data from 2 identical double-blind phase 3 studies demonstrated that patients with migraine who were assigned to sumatriptan plus naproxen were more likely to be pain-free at 2 hours and more likely to experience relief from both traditional and nontraditional migraine symptoms compared with those assigned to placebo.
The results were presented at the American Academy of Neurology 59th Annual Meeting, April 28 to May 5, 2007, in Boston, Massachusetts.
The studies utilized a single-tablet formulation of sumatriptan 85 mg plus naproxen 500 mg.
The studies incorporated an early intervention model in which patients were instructed to treat migraine pain within 1 hour of onset. Patients were randomized to 1 of 5 groups, and all were instructed to treat 4 migraine attacks with sumatriptan plus naproxen. Eighty percent of patients treated 3 of 4 attacks with sumatriptan plus naproxen and the remaining attack with placebo; 20% of patients treated all 4 attacks with sumatriptan plus naproxen.
In both studies, patients assigned to sumatriptan plus naproxen reported a significantly lower incidence of traditional (nausea, vomiting, photophobia, and phonophobia) and nontraditional (sinus pain/pressure and neck pain/
discomfort) migraine-associated symptoms compared with placebo at 2 and 4 hours after therapy. The absolute difference between sumatriptan plus naproxen and placebo at 2 hours for the occurrence of each symptom was 6% for nausea, 22% for photophobia, 18% for phonophobia, 14% for sinus pain/pressure, and 10% for neck pain/discomfort (P<.005 for all comparisons in favor of sumatriptan plus naproxen).
At 4 hours, the absolute difference in symptom occurrence between the 2 groups was 12% for nausea, 26% for photophobia, 24% for phonophobia, 16% for sinus pain/pressure, and 16% for neck pain/discomfort (P<.005 for all comparisons in favor of sumatriptan plus naproxen).