Fixed-dose sumatriptan and naproxen in poor responders to triptans with a short half-life.

Abstract

OBJECTIVE:

To evaluate efficacy and tolerability of a single, fixed-dose tablet of sumatriptan 85 mg/naproxen sodium 500 mg (sumatriptan/naproxen sodium) vs placebo in migraineurs who had discontinued treatment with a short-acting triptan because of poor response or intolerance.

BACKGROUND:

Triptan monotherapy is ineffective or poorly tolerated in 1 of 3 migraineurs and in 2 of 5 migraine attacks. In April, 2008, the Food and Drug Administration approved the combination therapy sumatriptan/naproxen sodium, developed specifically to target multiple migraine mechanisms. This combination product offers an alternative migraine therapy for patients who have reported poor response or intolerance to short-acting triptans.

METHODS:

Two replicate, randomized, multicenter, double-blind, placebo-controlled, 2-attack crossover trials evaluated migraineurs who had discontinued a short-acting triptan in the past year because of poor response or intolerance. Patients were instructed to treat within 1 hour and while pain was mild.

RESULTS:

Patients (n = 144 study 1; n = 139 study 2) had discontinued an average of 3.3 triptans before study entry. Sumatriptan/naproxen sodium was superior (P < .001) to placebo for 2- through 24-hour sustained pain-free response (primary end point) (study 1, 26% vs 8%; study 2, 31% vs 8%) and pain-free response 2 hours post dose (key secondary end point) (study 1, 40% vs 17%; study 2, 44% vs 14%). A similar pattern of results was observed for other end points that evaluated acute (2- or 4-hour), intermediate (8-hour), or 2- through 24-hour sustained response for migraine (ie, pain and associated symptoms), photophobia, phonophobia, or nausea (with the exception of nausea 2 and 4 hours post dose). The percentage of patients with at least 1 adverse event (regardless of causality) was 11% with sumatriptan/naproxen sodium compared with 4% with placebo in study 1 and 9% with sumatriptan/naproxen sodium compared with 5% with placebo in study 2. Only 1 adverse event in 1 study was reported in > or =2% of patients after treatment with sumatriptan/naproxen sodium and reported more frequently with sumatriptan/naproxen than placebo: chest discomfort was reported in 2% of subjects in study 1, and no events met this threshold in study 2. No serious adverse events attributed to study medication were reported in either study.

CONCLUSION:

In migraineurs who reported poor response to a short-acting triptan, sumatriptan/naproxen sodium was generally well tolerated and significantly more effective than placebo in conferring initial, intermediate, and sustained efficacy for pain and migraine-associated symptoms of photophobia and phonophobia.

• Authors: Ninan T Mathew, Stephen Landy, Stuart Stark, Gretchen E Tietjen, Frederick J Derosier, Jonathan White, Shelly E Lener, Deo Bukenya
• Journal: Headache (Headache) Vol. 49 Issue 7 Pg. 971-82 (Jul 2009) ISSN: 1526-4610 [Electronic] United States
• PMID: 19486178 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Cyclooxygenase Inhibitors
• Serotonin Receptor Agonists
• Tryptamines
• Naproxen
• Sumatriptan

Topics

• Adolescent
• Adult
• Aged
• Cross-Over Studies
• Cyclooxygenase Inhibitors (therapeutic use)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Drug Tolerance
• Female
• Half-Life
• Humans
• Male
• Middle Aged
• Migraine Disorders (drug therapy)
• Naproxen (therapeutic use)
• Serotonin Receptor Agonists (therapeutic use)
• Sumatriptan (therapeutic use)
• Treatment Outcome
• Tryptamines (therapeutic use)
• Young Adult