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A Randomized Trial

Jan Lewis Brandes, MD; David Kudrow, MD; Stuart R. Stark, MD; C. Phillip O’Carroll, MD; James U. Adelman, MD; Francis J. O’Donnell, DO; W. James Alexander, MD, MPH; Susan E. Spruill, MS; Pamela S. Barrett, PharmD; Shelly E. Lener, PharmD

JAMA. 2007;297:1443-1454.

Context  Multiple pathogenic mechanisms may be involved in generating the migraine symptom complex, and multimechanism-targeted therapy may confer advantages over monotherapy.

Objective  To evaluate the efficacy and safety of a fixed-dose tablet containing sumatriptan succinate and naproxen sodium relative to efficacy and safety of each monotherapy and placebo for the acute treatment of migraine.

Design, Setting, and Participants  Two replicate, randomized, double-blind, single-attack, parallel-group studies conducted among 1461 (study 1) and 1495 (study 2) patients at 118 US clinical centers who were diagnosed as having migraine and received study treatment for a moderate or severe migraine attack.

Interventions  Patients were randomized in a 1:1:1:1 ratio to receive a single tablet containing sumatriptan, 85 mg, and naproxen sodium, 500 mg; sumatriptan, 85 mg (monotherapy); naproxen sodium, 500 mg (monotherapy); or placebo, to be used after onset of a migraine with moderate to severe pain.

Main Outcome Measures  Primary outcome measures included the percentages of patients with headache relief 2 hours after dosing, absence of photophobia, absence of phonophobia, and absence of nausea for the comparison between sumatriptan–naproxen sodium and placebo, and the percentages of patients with sustained pain-free response for the comparison between sumatriptan–naproxen sodium and each monotherapy.

Results  Sumatriptan–naproxen sodium was more effective than placebo for headache relief at 2 hours after dosing (study 1, 65% vs 28%; P<.001 and study 2, 57% vs 29%; P<.001), absence of photophobia at 2 hours (58% vs 26%; P<.001 and 50% vs 32%; P<.001), and absence of phonophobia at 2 hours (61% vs 38%; P<.001 and 56% vs 34%; P<.001). The absence of nausea 2 hours after dosing was higher with sumatriptan–naproxen sodium than placebo in study 1 (71% vs 65%; P = .007), but in study 2 rates of absence of nausea did not differ between sumatriptan–naproxen sodium and placebo (65% vs 64%; P = .71). For 2- to 24-hour sustained pain-free response, sumatriptan–naproxen sodium was superior at P<.01 (25% and 23% in studies 1 and 2, respectively) to sumatriptan monotherapy (16% and 14% in studies 1 and 2), naproxen sodium monotherapy (10% and 10% in studies 1 and 2), and placebo (8% and 7% in studies 1 and 2). The incidence of adverse events was similar between sumatriptan–naproxen sodium and sumatriptan monotherapy.

Conclusion  Sumatriptan, 85 mg, plus naproxen sodium, 500 mg, as a single tablet for acute treatment of migraine resulted in more favorable clinical benefits compared with either monotherapy, with an acceptable and well-tolerated adverse effect profile.

Trial Registration  clinicaltrials.gov Identifiers: NCT00434083 (study 1); NCT00433732 (study 2)

Author Affiliations: Nashville Neuroscience Group, Nashville, Tenn (Dr Brandes); California Medical Clinic for Headache, Santa Monica (Dr Kudrow); The Innovative Clinical Research Center, Alexandria, Va (Dr Stark); Headache Institute, Newport Beach, Calif (Dr O’Carroll); Headache Wellness Center, Greensboro, NC (Dr Adelman); OrthoNeuro, Columbus, Ohio (Dr O’Donnell); Pozen Inc, Chapel Hill, NC (Dr Alexander and Ms Spruill); and GlaxoSmithKline, Research Triangle Park, NC (Drs Barrett and Lener).

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