TY - JOUR
T1 - Sumatriptan-naproxen sodium for menstrual migraine and dysmenorrhea
T2 - Satisfaction, productivity, and functional disability outcomes
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
PY - 2011/5
Y1 - 2011/5
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.
AB - 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.
KW - dysmenorrhea
KW - menstrual migraine
KW - sumatriptan-naproxen sodium
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U2 - 10.1111/j.1526-4610.2011.01894.x
DO - 10.1111/j.1526-4610.2011.01894.x
M3 - Article
C2 - 21521204
AN - SCOPUS:79955380412
SN - 0017-8748
VL - 51
SP - 664
EP - 673
JO - Headache
JF - Headache
IS - 5
ER -