Abstract | OBJECTIVE: METHODS: RESULTS:
Sumatriptan/naproxen sodium was more effective than placebo with respect to the co-primary efficacy endpoints two-hour pain-free response (29% sumatriptan/naproxen sodium vs 11% placebo, P < 0.001) and two- to 24-hour sustained pain-free response (24% sumatriptan/naproxen sodium vs 9% placebo, P < 0.001). Sumatriptan/naproxen sodium was significantly more effective than placebo with respect to the secondary efficacy endpoints of pain-free response four hours postdose ( P < 0.001), pain-free response maintained one to two hours postdose ( P = 0.034) and two to four hours postdose ( P < 0.001), headache relief four hours postdose ( P < 0.001), headache relief maintained two to four hours postdose ( P = 0.015), sustained headache relief two through 24 hours postdose ( P = 0.002), and rescue medication use ( P < 0.001); but not productivity scores. The most common adverse events were dizziness (4% sumatriptan/naproxen sodium,<1% placebo), dry mouth (2% sumatriptan/naproxen sodium, <1% placebo), and nausea (2% sumatriptan/naproxen sodium, <1% placebo). CONCLUSION:
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Authors | Stephen Silberstein, Susan A McDonald, Jerome Goldstein, Sheena Aurora, Shelly E Lener, Jonathan White, Michael C Runken, Jane Saiers, Frederick Derosier, Richard B Lipton |
Journal | Cephalalgia : an international journal of headache
(Cephalalgia)
Vol. 34
Issue 4
Pg. 268-79
(Apr 2014)
ISSN: 1468-2982 [Electronic] England |
PMID | 24108307
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Analgesics
- Drug Combinations
- Naproxen
- Sumatriptan
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Topics |
- Adult
- Analgesics
(therapeutic use)
- Double-Blind Method
- Drug Combinations
- Female
- Humans
- Male
- Migraine without Aura
(drug therapy)
- Naproxen
(therapeutic use)
- Sumatriptan
(therapeutic use)
- Treatment Outcome
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