title: Sumatriptan-naproxen migraine efficacy in allodynic patients: early intervention.
abstract: OBJECTIVE
  This study evaluated the effectiveness of a single fixed-dose tablet of sumatriptan 85 mg/naproxen sodium 500 mg (sumatriptan-naproxen) using a very early treatment paradigm in migraine patients whose attacks were historically accompanied by cutaneous allodynia.
  
  
  BACKGROUND
  Evidence suggests that allodynic migraineurs may demonstrate a better response when treated prior to developing central sensitization, and that these patients are treated more effectively with a compound of sumatriptan and naproxen sodium than either drug alone. This study targeted patients who have accompanying allodynia using a very early treatment paradigm where treatment was initiated while symptoms were still mild.
  
  
  METHODS
  This was an open-label prospective, outpatient study of adult migraineurs who had screened positive for cutaneous allodynia and typically experienced moderate to severe pain preceded by an identifiable mild pain phase. Patients were treated with sumatriptan-naproxen using a very early intervention paradigm in 4 test migraines over 12 weeks where dosage occurred within 30 minutes of symptom onset. Data from diaries and questionnaires were used to evaluate the primary endpoints of sustained pain-free response at 24 hours post dose (using no second dose of study drug and no other rescue drugs), and overall satisfaction with sumatriptan-naproxen.
  
  
  RESULTS
  Forty allodynic migraineurs enrolled in this study and reported a total of 160 migraines. Of these migraines, 78 (49%) achieved sustained pain-free at 24 hours and 94 (59%) were reported as pain-free at 2 hours. The number of patients who rated their Overall Satisfaction following treatment with sumatriptan-naproxen as "Satisfied" (satisfied or very satisfied) was 32 (80%) after the first migraine and 25 (63%) after 3 or more migraines.
  
  
  CONCLUSIONS
  In this open-label study, allodynic patients reported that their migraine attacks responded well and they achieved a high degree of satisfaction following treatment with a fixed-dose tablet of sumatriptan 85 mg/naproxen sodium 500 mg administered in a very early treatment paradigm.
authors: Wesley Headache Clinic, University of Tennessee Medical School, Memphis, TN, USA.
authors: Stephen
authors: S
authors: Landy
authors: Rebecca
authors: R
authors: Hoagland
authors: Nancy A
authors: NA
authors: Hoagland
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D004185:Disability Evaluation; D004359:Drug Therapy, Combination; D061345:Early Medical Intervention; D005260:Female; D006801:Humans; D006930:Hyperalgesia / Q000209:etiology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000150:complications / Q000188:drug therapy*; D009288:Naproxen / Q000627:therapeutic use*; D011446:Prospective Studies; D058825:Serotonin 5-HT1 Receptor Agonists / Q000627:therapeutic use*; D018170:Sumatriptan / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D058825:Serotonin 5-HT1 Receptor Agonists; D009288:Naproxen; D018170:Sumatriptan