title: Pregabalin Improves Pain Scores in Patients with Fibromyalgia Irrespective of Comorbid Osteoarthritis.
abstract: Fibromyalgia (FM) is a chronic pain disorder with patients frequently suffering from comorbid conditions, including osteoarthritis (OA). Data on how FM patients with comorbid OA respond to recommended therapies (such as pregabalin) could help their treatment.
  
  
  
  This was a pooled exploratory analysis of three randomized placebo-controlled clinical trials of pregabalin in FM patients to assess the impact of comorbid OA on the response to pregabalin.
  
  
  
  Patients were divided into those with and without comorbid OA. Difference in change in least squares (LS) mean pain score at endpoint (assessed by 0-10 numeric rating scale, controlled for baseline pain score) with pregabalin (300 mg/day and 450 mg/day) vs placebo was assessed. Changes in Patient Global Impression of Change (PGIC) responders and Fibromyalgia Impact Questionnaire (FIQ) total score were also assessed.
  
  
  
  There were 1665 patients in the analysis set (558, placebo; 552, pregabalin 300 mg/day; 555, pregabalin 450 mg/day), including 296 with comorbid OA. Pregabalin 450 mg/day significantly improved the LS mean (95% confidence interval) difference in pain score vs placebo in patients with (0.99 [0.44, 1.55], P < 0.001), and without (0.64 [0.39, 0.89], P < 0.001) OA. Improvements with pregabalin 300 mg/day with (0.31 [-0.25, 0.86], P = 0.276) and without (0.51 [0.25, 0.76], P < 0.001) OA were not consistently significant. Improvements in PGIC and FIQ total score were observed in patients with and without comorbid OA.
  
  
  
  FM patients with or without comorbid OA respond to treatment with pregabalin 450mg/day with significant improvements in pain intensity scores. These data could provide guidance to healthcare professionals treating these patients.
authors.affiliation: Albany Medical Center, Albany, New York pargoff@optonline.net.
authors.forename: Charles E
authors.initials: CE
authors.lastname: Argoff
authors.affiliation: Pfizer, New York, New York.
authors.forename: Birol
authors.initials: B
authors.lastname: Emir
authors.affiliation: Pfizer, New York, New York.
authors.forename: Ed
authors.initials: E
authors.lastname: Whalen
authors.affiliation: Pfizer, New York, New York.
authors.forename: Marie
authors.initials: M
authors.lastname: Ortiz
authors.affiliation: Pfizer, Groton, Connecticut, USA.
authors.forename: Lynne
authors.initials: L
authors.lastname: Pauer
authors.affiliation: Pfizer, New York, New York.
authors.forename: Andrew
authors.initials: A
authors.lastname: Clair
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000700:Analgesics / Q000494:pharmacology / Q000627:therapeutic use*; D015897:Comorbidity; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005356:Fibromyalgia / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D010146:Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D010147:Pain Measurement / Q000187:drug effects* / Q000379:methods; D000069583:Pregabalin / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000700:Analgesics; D000069583:Pregabalin
keywords: Clinical Trial; Fibromyalgia; Osteoarthritis; Pregabalin