Financial support: During the conduct of the study, POZEN was the IND sponsor of sumatriptan/naproxen sodium. GlaxoSmithKline financed, developed, and managed these studies under POZEN's IND.
Sumatriptan–Naproxen Sodium for Menstrual Migraine and Dysmenorrhea: Satisfaction, Productivity, and Functional Disability Outcomes
Article first published online: 26 APR 2011
© 2011 American Headache Society
Headache: The Journal of Head and Face Pain
Volume 51, Issue 5, pages 664–673, May 2011
How to Cite
Cady, R. K., Diamond, M. L., Diamond, M. P., Ballard, J. E., Lener, M. E., Dorner, D. P., Derosier, F. J., McDonald, S. A., White, J. and Runken, M. C. (2011), Sumatriptan–Naproxen Sodium for Menstrual Migraine and Dysmenorrhea: Satisfaction, Productivity, and Functional Disability Outcomes. Headache: The Journal of Head and Face Pain, 51: 664–673. doi: 10.1111/j.1526-4610.2011.01894.x
Clinical Trial Registration Numbers: study 1: NCT00329459; study 2: NCT00329355. URLs: http://clinicaltrials.gov/ct2/show/NCT00329459?term=NCT00329459&rank=1; http://clinicaltrials.gov/ct2/show/NCT00329355?term=NCT00329355&rank=1
Conflict of Interest: F.J. Derosier, M.E. Lener, S.A. McDonald, M. Chris Runken, and J. White receive stock as employees of GlaxoSmithKline, the maker of sumatriptan/naproxen sodium. J. Ballard has been a consultant for Bayer Pharmaceuticals, and served as a clinical consultant and advisor to GlaxoSmithKline for these 2 studies. R.K. Cady has been a clinical consultant/advisor to GlaxoSmithKline for these 2 studies as well as others, and has received honoraria and research grants from GlaxoSmithKline. He has served as a consultant for Astellas, Merck & Co., Inc., and Ortho-McNeil Neurologies, and on advisory boards for Astellas, Endo Pharmaceuticals Inc., KOWA Pharmaceuticals, MAP Pharmaceuticals, Merck & Co., Inc., Minster Pharmaceuticals, Nautilus Neuroscience, NuPathe, Ortho-McNeil Neurologies, POZEN, Prometheus Laboratories, and Zogenix. Dr. Cady has received honoraria from Astellas, Endo Pharmaceuticals Inc., KOWA Pharmaceuticals, MAP Pharmaceuticals, Merck & Co., Inc., Minster Pharmaceuticals, Nautilus Neuroscience, NuPathe, Ortho-McNeil Neurologies, Prometheus Laboratories, and Zogenix. He has also received research grants from Advanced Neuromodulation, Allergan, AstraZeneca, Boston Scientific, Endo Pharmaceuticals Inc., Johnson & Johnson, MAP Pharmaceuticals, Merck & Co., Inc., Puramed BioScience, and Wyeth. M.P. Diamond has served as a clinical investigator and consultant for GlaxoSmithKline for these 2 studies as well as others. M.L. Diamond has served as a clinical consultant/advisor to GlaxoSmithKline for these 2 studies. D.P. Dorner is an employee of Scientific Therapeutics Information, Inc., Springfield, NJ.
- Issue published online: 26 APR 2011
- Article first published online: 26 APR 2011
- Accepted for publication February 23, 2011.
- sumatriptan–naproxen sodium;
- menstrual migraine;
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 Technology™ 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.