title: Pregabalin in fibromyalgia: meta-analysis of efficacy and safety from company clinical trial reports.
abstract: OBJECTIVE
  Meta-analysis of pregabalin trials in FM using company trial reports, which provide more detailed information about trials than published papers. FM is a common condition with a significant impact on quality of life.
  
  
  METHODS
  Reports of five high-quality randomized trials (3808 patients) of pregabalin in FM were obtained from Pfizer. Four trials (2754 patients) were of classical trial design and one was an enriched enrolment randomized withdrawal design. Outcomes for meta-analysis from the four trials with classical design were pooled in an intention-to-treat analysis.
  
  
  RESULTS
  Significant benefit of pregabalin over placebo was seen for a variety of outcomes including mean pain and sleep scores, the proportion of patients achieving at least 50% pain relief and most of the individual domains of short-form 36. Only a minority of patients achieve moderate or substantial pain relief. The proportions of patients with any adverse event, somnolence or dizziness were also significantly greater with pregabalin than with placebo. There was no difference with regard to serious adverse events. A dose-response relationship was apparent for at least 50% pain relief and for adverse event outcomes.
  
  
  CONCLUSIONS
  Pregabalin is effective in treating FM and is relatively safe. The size of therapeutic effect is similar to that with other recent interventions such as duloxetine and the combination of tramadol and paracetamol. Enriched enrolment randomized withdrawal design gives similar results to classical trial designs in FM.
authors.affiliation: Department of Occupational and Social Medicine, University of Göttingen, Göttingen, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Straube
authors.forename: Sheena
authors.initials: S
authors.lastname: Derry
authors.forename: Robert A
authors.initials: RA
authors.lastname: Moore
authors.forename: Henry J
authors.initials: HJ
authors.lastname: McQuay
mesh_terms: D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D005356:Fibromyalgia / Q000188:drug therapy*; D006801:Humans; D010146:Pain / Q000188:drug therapy*; D010147:Pain Measurement / Q000187:drug effects*; D017060:Patient Satisfaction; D000069583:Pregabalin; D016032:Randomized Controlled Trials as Topic; D013223:Statistics as Topic; D016896:Treatment Outcome; D005680:gamma-Aminobutyric Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000700:Analgesics; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid