Abstract | OBJECTIVE: 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:
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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)
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Chemical References |
- Cyclooxygenase Inhibitors
- Serotonin Receptor Agonists
- Tryptamines
- Naproxen
- Sumatriptan
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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
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