Sumatriptan-naproxen sodium for menstrual migraine and dysmenorrhea: Satisfaction, productivity, and functional disability outcomes

Roger K. Cady, Merle L. Diamond, Michael Peter Diamond, Jeanne E. Ballard, Michelle E. Lener, Deborah P. Dorner, Frederick J. Derosier, Susan A. McDonald, Jonathan White, M. Chris Runken

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Objective.- To evaluate the impact of a sumatriptan/naproxen sodium combination tablet on patient satisfaction, productivity, and functional disability in menstrual migraine treated during the mild pain phase of a single menstrual migraine attack associated with dysmenorrhea. Background.- Menstrual migraineurs with dysmenorrhea represent a unique patient population not previously studied. When health outcomes end points are analyzed alongside traditional efficacy end points in migraine studies, a more comprehensive and robust understanding of the many factors that may influence patients' choice of and adherence to pharmacological treatments for migraine is observed. Methods.- In 2 replicate, multicenter, randomized, double-blind, placebo-controlled trials, participants with menstrual migraine and dysmenorrhea treated a single menstrual migraine attack with a single fixed-dose tablet of sumatriptan 85 mg formulated with RT TechnologyTM and naproxen sodium 500 mg (sumatriptan-naproxen sodium) or placebo. Results.- Participants randomized to sumatriptan-naproxen sodium were significantly more satisfied than those randomized to placebo at 24 hours post dose, as demonstrated by higher satisfaction subscale scores for efficacy (P <.001 for both studies), functionality (P =.003 for study 1; P <.001 for study 2), and ease of use (P =.027 for study 1; P =.011 for study 2). There was little bothersomeness of side effects associated with either treatment. Use of sumatriptan-naproxen sodium was also associated with lower reported "lost-time equivalents" in work and leisure time (pooled analysis, P =.003) and lower rates of functional disability (P =.05, study 1; P <.001, study 2) compared with placebo. Conclusion.- A fixed-dose combination tablet containing sumatriptan and naproxen sodium significantly improved patient satisfaction, productivity, and restoration of normal functioning in menstrual migraineurs with dysmenorrhea.

Original languageEnglish (US)
Pages (from-to)664-673
Number of pages10
JournalHeadache
Volume51
Issue number5
DOIs
StatePublished - May 1 2011
Externally publishedYes

Fingerprint

Dysmenorrhea
Naproxen
Migraine Disorders
Sumatriptan
Placebos
Tablets
Patient Satisfaction
Leisure Activities
Patient Compliance
sumatriptan-naproxen
Pharmacology
Pain
Health
Therapeutics
Population

Keywords

  • dysmenorrhea
  • menstrual migraine
  • sumatriptan-naproxen sodium

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

Cite this

Sumatriptan-naproxen sodium for menstrual migraine and dysmenorrhea : Satisfaction, productivity, and functional disability outcomes. / Cady, Roger K.; Diamond, Merle L.; Diamond, Michael Peter; Ballard, Jeanne E.; Lener, Michelle E.; Dorner, Deborah P.; Derosier, Frederick J.; McDonald, Susan A.; White, Jonathan; Runken, M. Chris.

In: Headache, Vol. 51, No. 5, 01.05.2011, p. 664-673.

Research output: Contribution to journalArticle

Cady, RK, Diamond, ML, Diamond, MP, Ballard, JE, Lener, ME, Dorner, DP, Derosier, FJ, McDonald, SA, White, J & Runken, MC 2011, 'Sumatriptan-naproxen sodium for menstrual migraine and dysmenorrhea: Satisfaction, productivity, and functional disability outcomes', Headache, vol. 51, no. 5, pp. 664-673. https://doi.org/10.1111/j.1526-4610.2011.01894.x
Cady, Roger K. ; Diamond, Merle L. ; Diamond, Michael Peter ; Ballard, Jeanne E. ; Lener, Michelle E. ; Dorner, Deborah P. ; Derosier, Frederick J. ; McDonald, Susan A. ; White, Jonathan ; Runken, M. Chris. / Sumatriptan-naproxen sodium for menstrual migraine and dysmenorrhea : Satisfaction, productivity, and functional disability outcomes. In: Headache. 2011 ; Vol. 51, No. 5. pp. 664-673.
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abstract = "Objective.- To evaluate the impact of a sumatriptan/naproxen sodium combination tablet on patient satisfaction, productivity, and functional disability in menstrual migraine treated during the mild pain phase of a single menstrual migraine attack associated with dysmenorrhea. Background.- Menstrual migraineurs with dysmenorrhea represent a unique patient population not previously studied. When health outcomes end points are analyzed alongside traditional efficacy end points in migraine studies, a more comprehensive and robust understanding of the many factors that may influence patients' choice of and adherence to pharmacological treatments for migraine is observed. Methods.- In 2 replicate, multicenter, randomized, double-blind, placebo-controlled trials, participants with menstrual migraine and dysmenorrhea treated a single menstrual migraine attack with a single fixed-dose tablet of sumatriptan 85 mg formulated with RT TechnologyTM and naproxen sodium 500 mg (sumatriptan-naproxen sodium) or placebo. Results.- Participants randomized to sumatriptan-naproxen sodium were significantly more satisfied than those randomized to placebo at 24 hours post dose, as demonstrated by higher satisfaction subscale scores for efficacy (P <.001 for both studies), functionality (P =.003 for study 1; P <.001 for study 2), and ease of use (P =.027 for study 1; P =.011 for study 2). There was little bothersomeness of side effects associated with either treatment. Use of sumatriptan-naproxen sodium was also associated with lower reported {"}lost-time equivalents{"} in work and leisure time (pooled analysis, P =.003) and lower rates of functional disability (P =.05, study 1; P <.001, study 2) compared with placebo. Conclusion.- A fixed-dose combination tablet containing sumatriptan and naproxen sodium significantly improved patient satisfaction, productivity, and restoration of normal functioning in menstrual migraineurs with dysmenorrhea.",
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AU - Cady, Roger K.

AU - Diamond, Merle L.

AU - Diamond, Michael Peter

AU - Ballard, Jeanne E.

AU - Lener, Michelle E.

AU - Dorner, Deborah P.

AU - Derosier, Frederick J.

AU - McDonald, Susan A.

AU - White, Jonathan

AU - Runken, M. Chris

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N2 - Objective.- To evaluate the impact of a sumatriptan/naproxen sodium combination tablet on patient satisfaction, productivity, and functional disability in menstrual migraine treated during the mild pain phase of a single menstrual migraine attack associated with dysmenorrhea. Background.- Menstrual migraineurs with dysmenorrhea represent a unique patient population not previously studied. When health outcomes end points are analyzed alongside traditional efficacy end points in migraine studies, a more comprehensive and robust understanding of the many factors that may influence patients' choice of and adherence to pharmacological treatments for migraine is observed. Methods.- In 2 replicate, multicenter, randomized, double-blind, placebo-controlled trials, participants with menstrual migraine and dysmenorrhea treated a single menstrual migraine attack with a single fixed-dose tablet of sumatriptan 85 mg formulated with RT TechnologyTM and naproxen sodium 500 mg (sumatriptan-naproxen sodium) or placebo. Results.- Participants randomized to sumatriptan-naproxen sodium were significantly more satisfied than those randomized to placebo at 24 hours post dose, as demonstrated by higher satisfaction subscale scores for efficacy (P <.001 for both studies), functionality (P =.003 for study 1; P <.001 for study 2), and ease of use (P =.027 for study 1; P =.011 for study 2). There was little bothersomeness of side effects associated with either treatment. Use of sumatriptan-naproxen sodium was also associated with lower reported "lost-time equivalents" in work and leisure time (pooled analysis, P =.003) and lower rates of functional disability (P =.05, study 1; P <.001, study 2) compared with placebo. Conclusion.- A fixed-dose combination tablet containing sumatriptan and naproxen sodium significantly improved patient satisfaction, productivity, and restoration of normal functioning in menstrual migraineurs with dysmenorrhea.

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