Sumatriptan/naproxen sodium for the acute treatment of probable migraine without aura

A randomized study

Stephen Silberstein, Susan A. McDonald, Jerome Goldstein, Sheena Aurora, Shelly E. Lener, Jonathan White, Michael C. Runken, Jane Saiers, Frederick Derosier, Richard B. Lipton

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Objective: Probable migraine is a common, disabling migraine subtype fulfilling all but one of the diagnostic criteria for migraine. This study was conducted to evaluate the efficacy and tolerability of sumatriptan/naproxen sodium for the acute treatment of probable migraine without aura. Methods: Patients treated a headache of probable migraine without aura when pain was moderate or severe with sumatriptan/naproxen sodium (n 222 intent-to-treat (ITT)) or placebo (n 221 ITT/complete case analysisa) in this randomized, double-blind, parallel-group study. 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: Sumatriptan/naproxen sodium is effective in the acute treatment of probable migraine as demonstrated by higher rates of freedom from pain and restoration of function.

Original languageEnglish (US)
Pages (from-to)268-279
Number of pages12
JournalCephalalgia
Volume34
Issue number4
DOIs
StatePublished - 2014

Fingerprint

Migraine without Aura
Naproxen
Placebos
Migraine Disorders
Headache
Therapeutics
sumatriptan-naproxen
Migraine with Aura
Pain
Dizziness
Nausea
Mouth

Keywords

  • clinical trial
  • headache
  • Migraine
  • probable migraine
  • sumatriptan/naproxen sodium

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Sumatriptan/naproxen sodium for the acute treatment of probable migraine without aura : A randomized study. / Silberstein, Stephen; McDonald, Susan A.; Goldstein, Jerome; Aurora, Sheena; Lener, Shelly E.; White, Jonathan; Runken, Michael C.; Saiers, Jane; Derosier, Frederick; Lipton, Richard B.

In: Cephalalgia, Vol. 34, No. 4, 2014, p. 268-279.

Research output: Contribution to journalArticle

Silberstein, S, McDonald, SA, Goldstein, J, Aurora, S, Lener, SE, White, J, Runken, MC, Saiers, J, Derosier, F & Lipton, RB 2014, 'Sumatriptan/naproxen sodium for the acute treatment of probable migraine without aura: A randomized study', Cephalalgia, vol. 34, no. 4, pp. 268-279. https://doi.org/10.1177/0333102413508242
Silberstein, Stephen ; McDonald, Susan A. ; Goldstein, Jerome ; Aurora, Sheena ; Lener, Shelly E. ; White, Jonathan ; Runken, Michael C. ; Saiers, Jane ; Derosier, Frederick ; Lipton, Richard B. / Sumatriptan/naproxen sodium for the acute treatment of probable migraine without aura : A randomized study. In: Cephalalgia. 2014 ; Vol. 34, No. 4. pp. 268-279.
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abstract = "Objective: Probable migraine is a common, disabling migraine subtype fulfilling all but one of the diagnostic criteria for migraine. This study was conducted to evaluate the efficacy and tolerability of sumatriptan/naproxen sodium for the acute treatment of probable migraine without aura. Methods: Patients treated a headache of probable migraine without aura when pain was moderate or severe with sumatriptan/naproxen sodium (n 222 intent-to-treat (ITT)) or placebo (n 221 ITT/complete case analysisa) in this randomized, double-blind, parallel-group study. 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: Sumatriptan/naproxen sodium is effective in the acute treatment of probable migraine as demonstrated by higher rates of freedom from pain and restoration of function.",
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AU - Goldstein, Jerome

AU - Aurora, Sheena

AU - Lener, Shelly E.

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AU - Runken, Michael C.

AU - Saiers, Jane

AU - Derosier, Frederick

AU - Lipton, Richard B.

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AB - Objective: Probable migraine is a common, disabling migraine subtype fulfilling all but one of the diagnostic criteria for migraine. This study was conducted to evaluate the efficacy and tolerability of sumatriptan/naproxen sodium for the acute treatment of probable migraine without aura. Methods: Patients treated a headache of probable migraine without aura when pain was moderate or severe with sumatriptan/naproxen sodium (n 222 intent-to-treat (ITT)) or placebo (n 221 ITT/complete case analysisa) in this randomized, double-blind, parallel-group study. 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: Sumatriptan/naproxen sodium is effective in the acute treatment of probable migraine as demonstrated by higher rates of freedom from pain and restoration of function.

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