title: Comparative pain and mood effects in patients with comorbid fibromyalgia and major depressive disorder: secondary analyses of four pooled randomized controlled trials of duloxetine.
abstract: The objective of this paper is to better understand the relationship of pain and mood in patients with fibromyalgia and comorbid major depressive disorder (MDD). Pooled data from 4 double-blind, placebo-controlled, randomized trials of duloxetine hydrochloride 60-120mg/day in patients with fibromyalgia were included (N=1332). Of these, 350 (26% [147 placebo, 203 duloxetine]) had comorbid MDD (per Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision criteria) and were included in these analyses. Primary measures included Brief Pain Inventory average pain; Hamilton Depression Rating Scale or Beck Depression Inventory. Logistic regression was used to evaluate the consistency of treatment effect across various subgroups. Path analysis was used to assess the effect of duloxetine on improvement in pain in the presence of improvement in mood and vice versa. Results indicated that 69% of improvement in pain was a direct effect of treatment, with improvement in mood accounting for 31% of pain response. In conclusion, consistent with our hypothesis, duloxetine produced a substantial direct effect on pain improvement and change in mood exerted a modest indirect effect on pain improvements in patients with fibromyalgia and MDD. Hence, both direct and indirect analgesic and antidepressant properties appear to be relevant for the treatment of these comorbid patients with duloxetine.
authors.affiliation: Lilly USA, LLC, Lilly Corporate Center, Indianapolis, Indiana 46285, USA University of Michigan Medical Center, Division of Rheumatology, Chronic Pain and Fatigue Research Center, Ann Arbor, Michigan 48109, USA King's College, Sir Alfred Baring Garrod Clinical Trials Unit, Academic Department of Rheumatology, London WC2A 1LR, UK University of Alabama at Birmingham, Division of Clinical Immunology and Rheumatology, 178A Shelby Interdisciplinary Research Bldg, Birmingham, Alabama 35294, USA Swedish Medical Center, Seattle Rheumatology Research, 1101 Madison, Suite 1000, Seattle, WA 98104, USA University of Washington School of Medicine, 1959 N.E. Pacific St. Seattle, WA 98195, USA.
authors.forename: Lauren B
authors.initials: LB
authors.lastname: Marangell
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Clauw
authors.forename: Ernest
authors.initials: E
authors.lastname: Choy
authors.forename: Fujun
authors.initials: F
authors.lastname: Wang
authors.forename: Scarlett
authors.initials: S
authors.lastname: Shoemaker
authors.forename: Laurence
authors.initials: L
authors.lastname: Bradley
authors.forename: Philip
authors.initials: P
authors.lastname: Mease
authors.forename: Madelaine M
authors.initials: MM
authors.lastname: Wohlreich
mesh_terms: D000328:Adult; D000339:Affect / Q000187:drug effects*; D000928:Antidepressive Agents / Q000627:therapeutic use*; D015897:Comorbidity; D003865:Major Depressive Disorder / Q000150:complications / Q000188:drug therapy / Q000453:epidemiology; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride; D005260:Female; D005356:Fibromyalgia / Q000150:complications / Q000188:drug therapy / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology*; D010147:Pain Measurement; D011569:Psychiatric Status Rating Scales; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D013876:Thiophenes / Q000627:therapeutic use*
chemical_list: D000928:Antidepressive Agents; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride