Sumatriptan + naproxen: better than either alone for acute migraine?

Journal of Family Practice, July, 2007 by J.L. Brandes, D. Kudrow, S.R. Stark

* Clinical question

Is a single tablet containing sumatriptan and naproxen superior to either agent alone in the treatment of acute migraine in adults?

* Bottom line

Yes. A single-tablet combination of sumatriptan (85 mg) plus naproxen sodium (500 mg) was better than either agent alone in the treatment of acute migraine. Outcomes measured included 2-hour headache relief and 24-hour sustained pain-free response.

This fixed combination is currently under FDA review and will be marketed under the trade name Trexima. This study used a single-pill combination, but separate pills taken concurrently are likely to be equally efficacious (and potentially less expensive as generics).

Level of evidence

1b-: Individual randomized controlled trial (with wide confidence interval)

Study design

Randomized controlled trial double-blinded)

Funding

Industry

Allocation

Uncertain

Setting

Outpatient (any)

Synopsis

A fixed combination of sumatriptan (85 mg) and naproxen sodium (500 mg) is currently under FDA review (trade name: Trexima). These authors report summary results from 2 multicenter trials including 3413 patients who randomly received either sumatriptan-naproxen, sumatriptan alone, naproxen alone, or placebo.

Patients, ages 18 to 65 years, who met International Headache Society criteria for migraine headaches, were recruited from primary care practices, neurology clinics, and headache clinics. Eligibility criteria included having an average of 2 to 6 migraines per month with or without aura. Patients with uncontrolled hypertension, cardiovascular disease, cerebrovascular disease, and cardiac arrhythmias were excluded.

Complete follow-up occurred for 85% of patients for 6 weeks. The remaining patients did not try the study medication during the entire 6-week period. Analysis was by intention to treat.

The incidence of headache relief at 2 hours was 61% for sumatriptan-naproxen, 52% for sumatriptan, 44% for naproxen, and 30% for placebo (number needed to treat [NNT]=6 for sumatriptan-naproxen vs naproxen; NNT=11 for sumatriptan-naproxen vs sumatriptan). Sumatriptan-naproxen was also significantly superior to all other agents for sustained headache relief at 24 hours. Side effects of sumatriptan-naproxen were equivalent to those seen with sumatriptan alone. It is important to note, however, that this dose (85 mg) is less than the 100 mg dose commonly prescribed in sumatriptan monotherapy.

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FAST TRACK

Headache relief at 2 hours was better with the combination pill than either agent alone

Brandes JL, Kudrow D, Stark SR, et al. Sumatriptan-naproxen for the acute treatment of migraine: A randomized trial. JAMA 2007; 297:1443-1454.