Sumatriptan-naproxen for acute treatment of migraine: a randomized trial.

Abstract

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).

• Authors: Jan Lewis Brandes, David Kudrow, Stuart R Stark, C Phillip O'Carroll, James U Adelman, Francis J O'Donnell, W James Alexander, Susan E Spruill, Pamela S Barrett, Shelly E Lener
• Journal: JAMA (JAMA) Vol. 297 Issue 13 Pg. 1443-54 (Apr 04 2007) ISSN: 1538-3598 [Electronic] United States
• PMID: 17405970 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Drug Combinations
• Tablets
• Vasoconstrictor Agents
• Naproxen
• Sumatriptan

Topics

• Adult
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, therapeutic use)
• Double-Blind Method
• Drug Combinations
• Female
• Humans
• Male
• Middle Aged
• Migraine Disorders (drug therapy)
• Naproxen (administration & dosage, therapeutic use)
• Sumatriptan (administration & dosage, therapeutic use)
• Tablets
• Vasoconstrictor Agents (administration & dosage, therapeutic use)