Sumatriptan/naproxen sodium for the acute treatment of probable migraine without aura: A randomized study

Objective: Probable migraine is a common, disabling migraine subtype fulfilling all but one of the diagnostic criteria for migraine. This study was conducted to evaluate the efficacy and tolerability of sumatriptan/naproxen sodium for the acute treatment of probable migraine without aura. Methods: Patients treated a headache of probable migraine without aura when pain was moderate or severe with sumatriptan/naproxen sodium (n 222 intent-to-treat (ITT)) or placebo (n 221 ITT/complete case analysisa) in this randomized, double-blind, parallel-group study. Results: Sumatriptan/naproxen sodium was more effective than placebo with respect to the co-primary efficacy endpoints two-hour pain-free response (29% sumatriptan/naproxen sodium vs 11% placebo, p<0.001) and two- to 24-hour sustained pain-free response (24% sumatriptan/naproxen sodium vs 9% placebo, p<0.001). Sumatriptan/naproxen sodium was significantly more effective than placebo with respect to the secondary efficacy endpoints of pain-free response four hours postdose (p<0.001), pain-free response maintained one to two hours postdose (p 0.034) and two to four hours postdose (p<0.001), headache relief four hours postdose (p<0.001), headache relief maintained two to four hours postdose (p 0.015), sustained headache relief two through 24 hours postdose (p 0.002), and rescue medication use (p<0.001); but not productivity scores. The most common adverse events were dizziness (4% sumatriptan/ naproxen sodium,<1% placebo), dry mouth (2% sumatriptan/naproxen sodium, <1% placebo), and nausea (2% sumatriptan/naproxen sodium, <1% placebo). Conclusion: Sumatriptan/naproxen sodium is effective in the acute treatment of probable migraine as demonstrated by higher rates of freedom from pain and restoration of function.