title: An international, randomized, double-blind, placebo-controlled, phase III trial of pregabalin monotherapy in treatment of patients with fibromyalgia.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of pregabalin monotherapy versus placebo for symptomatic pain relief and improvement of patient global assessment in patients with fibromyalgia (FM) enrolled from countries outside the United States.
  
  
  METHODS
  This international, multicenter, double-blind, placebo-controlled trial randomly assigned 747 patients with FM to placebo or 300, 450, or 600 mg/day pregabalin twice daily for 14 weeks. Primary efficacy measures were endpoint mean pain scores and Patient Global Impression of Change (PGIC). Secondary outcomes included assessments of sleep and function.
  
  
  RESULTS
  Patients in the 450 mg/day pregabalin group showed significant improvements versus placebo in endpoint mean pain score (-0.56; p = 0.0132), PGIC (73% improved vs 56% placebo; p = 0.0017), and function [Fibromyalgia Impact Questionnaire (FIQ) total score -5.85; p = 0.0012]. PGIC was also significant for 600 mg/day pregabalin (69% improved; p = 0.0227). Results for these endpoints were nonsignificant for pregabalin at 300 mg/day and for pain and FIQ score at 600 mg/day. Early onset of pain relief was seen, with separation from placebo detected by Week 1 in all pregabalin groups. All pregabalin doses demonstrated superiority to placebo on the Medical Outcomes Study-Sleep Scale Sleep Disturbance subscale and the Sleep Quality diary. Dizziness and somnolence were the most frequently reported adverse events.
  
  
  CONCLUSIONS
  Pregabalin demonstrated modest efficacy in pain, global assessment, and function in FM at 450 mg/day, and improved sleep across all dose levels, but it did not provide consistent evidence of benefit at 300 and 600 mg/day in this study. Pregabalin was generally well tolerated for the treatment of FM. (Clinical trial registry NCT00333866).
authors.affiliation: Pfizer Global Research and Development, Groton, CT 06340, USA. lynne.pauer@pfizer.com
authors.forename: Lynne
authors.initials: L
authors.lastname: Pauer
authors.forename: Andreas
authors.initials: A
authors.lastname: Winkelmann
authors.forename: Pierre
authors.initials: P
authors.lastname: Arsenault
authors.forename: Anders
authors.initials: A
authors.lastname: Jespersen
authors.forename: Laurence
authors.initials: L
authors.lastname: Whelan
authors.forename: Gary
authors.initials: G
authors.lastname: Atkinson
authors.forename: Teresa
authors.initials: T
authors.lastname: Leon
authors.forename: Bernhardt
authors.initials: B
authors.lastname: Zeiher
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000700:Analgesics / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005356:Fibromyalgia / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000627:therapeutic use*; D000069583:Pregabalin; D012890:Sleep / Q000187:drug effects; D012893:Sleep Wake Disorders / Q000188:drug therapy / Q000209:etiology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult; D005680:gamma-Aminobutyric Acid / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use
chemical_list: D000700:Analgesics; D010919:Placebos; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid