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Sumatriptan-Naproxen Combination Effective Against Migraine

Dual therapy targets multiple mechanisms.

The pathophysiology of migraine headache includes the release of vasoactive and inflammatory chemicals, resulting in vasodilatation and meningeal and vascular inflammation. Triptans and nonsteroidal anti-inflammatory drugs mitigate different parts of this cascade. Researchers assessed the efficacy of dual therapy in two manufacturer-funded, randomized, double-blind, parallel-group studies conducted in a total of 2956 patients at 118 U.S. clinical centers.

Patients aged 18 to 65 with at least a 6-month history of migraine headache and a monthly average of two to six moderate or severe episodes were randomized to one of four treatments to be taken after migraine onset: a single tablet containing either sumatriptan (85 mg) plus naproxen sodium (500 mg), sumatriptan only, naproxen only, or placebo. (We provide data only for 1 study when results for the 2 studies are statistically similar.)

After 2 hours, sumatriptan plus naproxen was significantly more effective than placebo for headache relief, defined as reduction of pain from moderate or severe to mild or none without use of rescue medications (incidence, 65% vs. 28%), absence of photophobia (58% vs. 36%), and absence of phonophobia (61% vs. 38%). Absence of nausea at 2 hours was significantly more common with combined therapy than with placebo in study 1 (71% vs. 65%), but not in study 2 (65% vs. 68%). The incidence of sustained (24 hours) pain-free response was significantly higher with combined therapy (25%) than with sumatriptan (16%), naproxen (10%), or placebo (8%). Although all groups had low rates (<5%) of adverse events, such as dizziness, paresthesias, and somnolence, the overall incidence of adverse events was significantly higher with combined therapy (27%) than with placebo (12%) or naproxen (13%), but not sumatriptan (24%).

Comment: Despite the introduction of seven different triptans, patients with migraine headache continue to have poor responses to myriad treatment regimens. Migraine remains a frequent cause of emergency department visits. This methodologically rigorous pair of trials, the first to study a triptan-NSAID combination, yielded very promising results and provides sufficient evidence to support the use of this combination therapy in the ED. The authors postulate that the two drugs confer complementary therapeutic effects and alter pharmacokinetics to prolong treatment benefits.

— John A. Marx, MD, FAAEM, FACEP

Published in Journal Watch Emergency Medicine April 20, 2007

Citation(s):

Brandes JL et al. Sumatriptan-naproxen for acute treatment of migraine: A randomized trial. JAMA 2007 Apr 4; 297:1443-54.

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