title: A 1-year safety and efficacy study of duloxetine in patients with fibromyalgia.
abstract: OBJECTIVE
  Evaluate the efficacy and safety of duloxetine at doses up to 120 mg once daily in patients with fibromyalgia.
  
  
  METHODS
  This was a phase 3, 60-week study, which included an 8-week open-label period followed by a 52-week, randomized, double-blind period. Patients received duloxetine 30 mg daily for 1 week and duloxetine 60 mg daily for 7 weeks and were then randomized to receive either 60 or 120 mg daily (1:2 ratio).
  
  
  RESULTS
  Enrolled patients (N=350, 95.7% female) exhibited moderate disease symptoms at study entry (Brief Pain Inventory average pain=6.7, Clinical Global Impression of Severity=4.1, and Patient's Global Impression of Severity=4.1). Significant pain reduction in patients was observed during the open-label study phase. This pain reduction continued during the 52-week double-blind study phase, as demonstrated by additional mean decreases in the Brief Pain Inventory average pain score within both duloxetine groups. The most common (> or =15%) treatment-emergent adverse events (overall phase) were nausea, headache, insomnia, dizziness, constipation, and dry mouth. Seventy-four (21.1%) patients reported adverse events as a reason for discontinuation [most common (>1%) were insomnia, vomiting, diarrhea, dizziness, and nausea]. The mean change (SD) in sitting systolic blood pressure (mm Hg) was -0.1 (14.4), in sitting diastolic blood pressure was -0.2 (9.6), in sitting pulse rate was 1.9 (10.4) bpm, and in weight was 0.7 (4.3) kg.
  
  
  CONCLUSIONS
  The profile of duloxetine for the long-term treatment of fibromyalgia was consistent with that seen in other indications for which the drug is currently marketed.
authors.affiliation: Lilly Research Laboratories, Eli Lilly and Co, Indianapolis, IN 46285, USA. aschappell@lilly.com
authors.forename: Amy S
authors.initials: AS
authors.lastname: Chappell
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Littlejohn
authors.forename: Daniel K
authors.initials: DK
authors.lastname: Kajdasz
authors.forename: Morton
authors.initials: M
authors.lastname: Scheinberg
authors.forename: Deborah N
authors.initials: DN
authors.lastname: D'Souza
authors.forename: Harvey
authors.initials: H
authors.lastname: Moldofsky
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015897:Comorbidity; D018765:Dopamine Uptake Inhibitors / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D000068736:Duloxetine Hydrochloride; D005260:Female; D005356:Fibromyalgia / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D006801:Humans; D038622:Internationality; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000175:diagnosis / Q000453:epidemiology* / Q000517:prevention & control*; D010147:Pain Measurement / Q000187:drug effects; D013876:Thiophenes / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018765:Dopamine Uptake Inhibitors; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride