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

Abstract

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 analysis (a) ) 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.

• Authors: Stephen Silberstein, Susan A McDonald, Jerome Goldstein, Sheena Aurora, Shelly E Lener, Jonathan White, Michael C Runken, Jane Saiers, Frederick Derosier, Richard B Lipton
• Journal: Cephalalgia : an international journal of headache (Cephalalgia) Vol. 34 Issue 4 Pg. 268-79 (Apr 2014) ISSN: 1468-2982 [Electronic] England
• PMID: 24108307 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Analgesics
• Drug Combinations
• Naproxen
• Sumatriptan

Topics

• Adult
• Analgesics (therapeutic use)
• Double-Blind Method
• Drug Combinations
• Female
• Humans
• Male
• Migraine without Aura (drug therapy)
• Naproxen (therapeutic use)
• Sumatriptan (therapeutic use)
• Treatment Outcome