title: Pain response profile of patients with fibromyalgia treated with duloxetine.
abstract: OBJECTIVE
  This study examined the time course for minimal clinically significant improvement in pain severity during the initial 12 weeks of treatment in patients with fibromyalgia taking duloxetine.
  
  
  METHODS
  Four double-blind, placebo-controlled trials of duloxetine were pooled. Patients received duloxetine 60 mg/d, 120 mg/d, or placebo. Clinically significant treatment response (>or=30% reduction in pain severity on the 24-hour average pain severity of the Brief Pain Inventory scale) was assessed over 12 weeks.
  
  
  RESULTS
  At endpoint, 46.9% of duloxetine 60-mg-, 48.6% of duloxetine 120-mg-, and 32.1% of placebo-treated patients (P<0.001 for both doses) had >or=30% improvement on average pain from baseline. The probabilities of achieving >or=30% response at Weeks 1, 2, 4, 8, and 12 among duloxetine 60-mg-treated patients were 27%, 44%, 45%, 47%, and 49%, respectively, and among duloxetine 120-mg-treated patients were 35%, 43%, 53%, 53%, and 51%, respectively (P<0.01 vs. placebo at each week, for both doses). Among patients who did not respond by Weeks 1, 2, 4, and 8, the percentages of duloxetine 60-mg-treated patients who achieved a response by the endpoint of the study were 36.9%, 29.8%, 28.9%, and 26.9%, respectively.
  
  
  CONCLUSIONS
  This article examines the time course for minimal clinically significant improvement in pain severity in duloxetine-treated patients with fibromyalgia. It provides information about continued treatment in patients who do not initially respond to duloxetine. This information could potentially help physicians facing clinical decisions about management of fibromyalgia with duloxetine.
authors.affiliation: University of Alabama at Birmingham, Birmingham, AL, USA.
authors.forename: Laurence A
authors.initials: LA
authors.lastname: Bradley
authors.forename: Madelaine M
authors.initials: MM
authors.lastname: Wohlreich
authors.forename: Fujun
authors.initials: F
authors.lastname: Wang
authors.forename: Paula J
authors.initials: PJ
authors.lastname: Gaynor
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Robinson
authors.forename: Deborah N
authors.initials: DN
authors.lastname: D'Souza
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Mease
mesh_terms: D018759:Adrenergic Uptake Inhibitors / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride; D005260:Female; D005356:Fibromyalgia / Q000150:complications* / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy* / Q000209:etiology*; D010147:Pain Measurement / Q000379:methods; D013876:Thiophenes / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018759:Adrenergic Uptake Inhibitors; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride