title: A randomized, double-blind, placebo-controlled trial of duloxetine in the treatment of women with fibromyalgia with or without major depressive disorder.
abstract: This was a 12-week, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of duloxetine, a selective serotonin and norepinephrine reuptake inhibitor, in 354 female patients with primary fibromyalgia, with or without current major depressive disorder. Patients (90% Caucasian; mean age, 49.6 years; 26% with current major depressive disorder) received duloxetine 60 mg once daily (QD) (N=118), duloxetine 60 mg twice daily (BID) (N=116), or placebo (N=120). The primary outcome was the Brief Pain Inventory average pain severity score. Response to treatment was defined as >or=30% reduction in this score. Compared with placebo, both duloxetine-treated groups improved significantly more (P<0.001) on the Brief Pain Inventory average pain severity score. A significantly higher percentage of duloxetine-treated patients had a decrease of >or=30% in this score (duloxetine 60 mg QD (55%; P<0.001); duloxetine 60 mg BID (54%; P=0.002); placebo (33%)). The treatment effect of duloxetine on pain reduction was independent of the effect on mood and the presence of major depressive disorder. Compared with patients on placebo, patients treated with duloxetine 60 mg QD or duloxetine 60 mg BID had significantly greater improvement in remaining Brief Pain Inventory pain severity and interference scores, Fibromyalgia Impact Questionnaire, Clinical Global Impression of Severity, Patient Global Impression of Improvement, and several quality-of-life measures. Both doses of duloxetine were safely administered and well tolerated. In conclusion, both duloxetine 60 mg QD and duloxetine 60 mg BID were effective and safe in the treatment of fibromyalgia in female patients with or without major depressive disorder.
authors.affiliation: Women's Health Research Program, Department of Psychiatry, University of Cincinnati College of Medicine, Medical Arts Building, 222 Piedmont Ave, Suite 8200, Cincinnati, OH 45219, USA Lilly Research Laboratories, Indianapolis, IN, USA Indiana University Medical School and PRN Consulting, Indianapolis, IN, USA.
authors.forename: Lesley M
authors.initials: LM
authors.lastname: Arnold
authors.forename: Amy
authors.initials: A
authors.lastname: Rosen
authors.forename: Yili Lu
authors.initials: YL
authors.lastname: Pritchett
authors.forename: Deborah N
authors.initials: DN
authors.lastname: D'Souza
authors.forename: David J
authors.initials: DJ
authors.lastname: Goldstein
authors.forename: Smriti
authors.initials: S
authors.lastname: Iyengar
authors.forename: Joachim F
authors.initials: JF
authors.lastname: Wernicke
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000700:Analgesics / Q000008:administration & dosage; D000928:Antidepressive Agents / Q000008:administration & dosage; D015897:Comorbidity; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000453:epidemiology*; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride; D005260:Female; D005356:Fibromyalgia / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D006801:Humans; D008875:Middle Aged; D010147:Pain Measurement; D015990:Placebo Effect; D011788:Quality of Life; D013876:Thiophenes / Q000627:therapeutic use*; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D016387:Women's Health
chemical_list: D000700:Analgesics; D000928:Antidepressive Agents; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride