title: Sumatriptan-naproxen sodium for menstrual migraine and dysmenorrhea: satisfaction, productivity, and functional disability outcomes.
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 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Headache Care Center, Springfield, MO, USA.
authors.forename: Roger K
authors.initials: RK
authors.lastname: Cady
authors.forename: Merle L
authors.initials: ML
authors.lastname: Diamond
authors.forename: Michael P
authors.initials: MP
authors.lastname: Diamond
authors.forename: Jeanne E
authors.initials: JE
authors.lastname: Ballard
authors.forename: Michelle E
authors.initials: ME
authors.lastname: Lener
authors.forename: Deborah P
authors.initials: DP
authors.lastname: Dorner
authors.forename: Frederick J
authors.initials: FJ
authors.lastname: Derosier
authors.forename: Susan A
authors.initials: SA
authors.lastname: McDonald
authors.forename: Jonathan
authors.initials: J
authors.lastname: White
authors.forename: M Chris
authors.initials: MC
authors.lastname: Runken
mesh_terms: D000328:Adult; D000700:Analgesics / Q000008:administration & dosage*; D004311:Double-Blind Method; D004338:Drug Combinations; D004412:Dysmenorrhea / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008881:Migraine Disorders / Q000188:drug therapy* / Q000209:etiology; D009288:Naproxen / Q000008:administration & dosage*; D017060:Patient Satisfaction; D011293:Premenstrual Syndrome / Q000188:drug therapy*; D018170:Sumatriptan / Q000008:administration & dosage*
chemical_list: D000700:Analgesics; D004338:Drug Combinations; D009288:Naproxen; D018170:Sumatriptan