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Cephalalgia. 2014 Apr;34(4):268-79. doi: 10.1177/0333102413508242. Epub 2013 Oct 9.

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

Author information

1
Jefferson Headache Center, USA.

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.

KEYWORDS:

Migraine; clinical trial; headache; probable migraine; sumatriptan/naproxen sodium

PMID:
24108307
DOI:
10.1177/0333102413508242
[Indexed for MEDLINE]

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