title: Efficacy and Safety of Pregabalin in Patients with Fibromyalgia and Comorbid Depression Taking Concurrent Antidepressant Medication: A Randomized, Placebo-controlled Study.
abstract: OBJECTIVE
  To assess pregabalin efficacy and safety in patients with fibromyalgia (FM) with comorbid depression taking concurrent antidepressant medication.
  
  
  METHODS
  This randomized, placebo-controlled, double-blind, 2-period, 2-way crossover study was composed of two 6-week treatment periods separated by a 2-week taper/washout phase. Patients with FM (aged ≥ 18 yrs) taking a stable dose of a selective serotonin reuptake inhibitor (SSRI) or a serotonin/norepinephrine reuptake inhibitor (SNRI) for depression were randomized 1:1 to receive pregabalin/placebo or placebo/pregabalin (optimized to 300 or 450 mg/day). Antidepressant medication was continued throughout the study. The primary efficacy outcome was the mean pain score on an 11-point numerical rating scale. Secondary efficacy outcomes included measures of anxiety, depression, patient function, and sleep.
  
  
  RESULTS
  Of 197 patients randomized to treatment, 181 and 177 received ≥ 1 dose of pregabalin and placebo, respectively. At baseline, 52.3% of patients were taking an SSRI and 47.7% an SNRI, and mean pain score was 6.7. Mean pain scores at endpoint were statistically significantly reduced with pregabalin (least squares mean difference from placebo -0.61, 95% CI -0.91 - -0.31, p = 0.0001). Pregabalin significantly improved Hospital Anxiety and Depression Scale-Anxiety (difference -0.95, p < 0.0001) and -Depression (difference -0.88, p = 0.0005) scores, Fibromyalgia Impact Questionnaire total score (difference -6.60, p < 0.0001), and sleep quality (difference 0.57, p < 0.0001), but not EuroQol 5-Dimensions score (difference 0.02, p = 0.3854). Pregabalin safety was consistent with previous studies and current product labeling.
  
  
  CONCLUSIONS
  Compared with placebo, pregabalin statistically significantly improved FM pain and other symptoms in patients taking antidepressant medication for comorbid depression. ClinicalTrials.gov identifier: NCT01432236.
authors.affiliation: From the Women's Health Research Program, University of Cincinnati College of Medicine, Cincinnati, Ohio; Pfizer Inc., Groton, Connecticut; Pfizer Inc., New York, New York, USA; Reumatologia, Azienda Ospedaliera Polo Universitario L. Sacco, Milan, Italy; Family Medicine Department, University of Sherbrooke, Sherbrooke, Quebec, Canada.L.M. Arnold, MD, Professor of Psychiatry and Behavioral Neuroscience and Director, Women's Health Research Program, University of Cincinnati College of Medicine; P. Sarzi-Puttini, MD, Direttore presso U.O.C., Reumatologia, Azienda Ospedaliera Polo Universitario L. Sacco; P. Arsenault, MD, Associate Professor, Family Medicine Department, University of Sherbrooke; T. Khan, MD, Senior Manager Clinician, Clinical Sciences, Pfizer Inc.; P. Bhadra Brown, PhD, Director, Statistics, Pfizer Inc.; A. Clair, PhD, Senior Medical Director, US Medical Affairs, Pfizer Inc.; J.M. Scavone, PharmD, Senior Director; J. Driscoll, PharmD, Director; J. Landen, PhD, Director; L. Pauer, MS, Senior Director, Clinical Sciences, Pfizer Inc. arnoldlm@ucmail.uc.edu.
authors.forename: Lesley M
authors.initials: LM
authors.lastname: Arnold
authors.affiliation: From the Women's Health Research Program, University of Cincinnati College of Medicine, Cincinnati, Ohio; Pfizer Inc., Groton, Connecticut; Pfizer Inc., New York, New York, USA; Reumatologia, Azienda Ospedaliera Polo Universitario L. Sacco, Milan, Italy; Family Medicine Department, University of Sherbrooke, Sherbrooke, Quebec, Canada.L.M. Arnold, MD, Professor of Psychiatry and Behavioral Neuroscience and Director, Women's Health Research Program, University of Cincinnati College of Medicine; P. Sarzi-Puttini, MD, Direttore presso U.O.C., Reumatologia, Azienda Ospedaliera Polo Universitario L. Sacco; P. Arsenault, MD, Associate Professor, Family Medicine Department, University of Sherbrooke; T. Khan, MD, Senior Manager Clinician, Clinical Sciences, Pfizer Inc.; P. Bhadra Brown, PhD, Director, Statistics, Pfizer Inc.; A. Clair, PhD, Senior Medical Director, US Medical Affairs, Pfizer Inc.; J.M. Scavone, PharmD, Senior Director; J. Driscoll, PharmD, Director; J. Landen, PhD, Director; L. Pauer, MS, Senior Director, Clinical Sciences, Pfizer Inc.
authors.forename: Piercarlo
authors.initials: P
authors.lastname: Sarzi-Puttini
authors.affiliation: From the Women's Health Research Program, University of Cincinnati College of Medicine, Cincinnati, Ohio; Pfizer Inc., Groton, Connecticut; Pfizer Inc., New York, New York, USA; Reumatologia, Azienda Ospedaliera Polo Universitario L. Sacco, Milan, Italy; Family Medicine Department, University of Sherbrooke, Sherbrooke, Quebec, Canada.L.M. Arnold, MD, Professor of Psychiatry and Behavioral Neuroscience and Director, Women's Health Research Program, University of Cincinnati College of Medicine; P. Sarzi-Puttini, MD, Direttore presso U.O.C., Reumatologia, Azienda Ospedaliera Polo Universitario L. Sacco; P. Arsenault, MD, Associate Professor, Family Medicine Department, University of Sherbrooke; T. Khan, MD, Senior Manager Clinician, Clinical Sciences, Pfizer Inc.; P. Bhadra Brown, PhD, Director, Statistics, Pfizer Inc.; A. Clair, PhD, Senior Medical Director, US Medical Affairs, Pfizer Inc.; J.M. Scavone, PharmD, Senior Director; J. Driscoll, PharmD, Director; J. Landen, PhD, Director; L. Pauer, MS, Senior Director, Clinical Sciences, Pfizer Inc.
authors.forename: Pierre
authors.initials: P
authors.lastname: Arsenault
authors.affiliation: From the Women's Health Research Program, University of Cincinnati College of Medicine, Cincinnati, Ohio; Pfizer Inc., Groton, Connecticut; Pfizer Inc., New York, New York, USA; Reumatologia, Azienda Ospedaliera Polo Universitario L. Sacco, Milan, Italy; Family Medicine Department, University of Sherbrooke, Sherbrooke, Quebec, Canada.L.M. Arnold, MD, Professor of Psychiatry and Behavioral Neuroscience and Director, Women's Health Research Program, University of Cincinnati College of Medicine; P. Sarzi-Puttini, MD, Direttore presso U.O.C., Reumatologia, Azienda Ospedaliera Polo Universitario L. Sacco; P. Arsenault, MD, Associate Professor, Family Medicine Department, University of Sherbrooke; T. Khan, MD, Senior Manager Clinician, Clinical Sciences, Pfizer Inc.; P. Bhadra Brown, PhD, Director, Statistics, Pfizer Inc.; A. Clair, PhD, Senior Medical Director, US Medical Affairs, Pfizer Inc.; J.M. Scavone, PharmD, Senior Director; J. Driscoll, PharmD, Director; J. Landen, PhD, Director; L. Pauer, MS, Senior Director, Clinical Sciences, Pfizer Inc.
authors.forename: Tahira
authors.initials: T
authors.lastname: Khan
authors.affiliation: From the Women's Health Research Program, University of Cincinnati College of Medicine, Cincinnati, Ohio; Pfizer Inc., Groton, Connecticut; Pfizer Inc., New York, New York, USA; Reumatologia, Azienda Ospedaliera Polo Universitario L. Sacco, Milan, Italy; Family Medicine Department, University of Sherbrooke, Sherbrooke, Quebec, Canada.L.M. Arnold, MD, Professor of Psychiatry and Behavioral Neuroscience and Director, Women's Health Research Program, University of Cincinnati College of Medicine; P. Sarzi-Puttini, MD, Direttore presso U.O.C., Reumatologia, Azienda Ospedaliera Polo Universitario L. Sacco; P. Arsenault, MD, Associate Professor, Family Medicine Department, University of Sherbrooke; T. Khan, MD, Senior Manager Clinician, Clinical Sciences, Pfizer Inc.; P. Bhadra Brown, PhD, Director, Statistics, Pfizer Inc.; A. Clair, PhD, Senior Medical Director, US Medical Affairs, Pfizer Inc.; J.M. Scavone, PharmD, Senior Director; J. Driscoll, PharmD, Director; J. Landen, PhD, Director; L. Pauer, MS, Senior Director, Clinical Sciences, Pfizer Inc.
authors.forename: Pritha
authors.initials: P
authors.lastname: Bhadra Brown
authors.affiliation: From the Women's Health Research Program, University of Cincinnati College of Medicine, Cincinnati, Ohio; Pfizer Inc., Groton, Connecticut; Pfizer Inc., New York, New York, USA; Reumatologia, Azienda Ospedaliera Polo Universitario L. Sacco, Milan, Italy; Family Medicine Department, University of Sherbrooke, Sherbrooke, Quebec, Canada.L.M. Arnold, MD, Professor of Psychiatry and Behavioral Neuroscience and Director, Women's Health Research Program, University of Cincinnati College of Medicine; P. Sarzi-Puttini, MD, Direttore presso U.O.C., Reumatologia, Azienda Ospedaliera Polo Universitario L. Sacco; P. Arsenault, MD, Associate Professor, Family Medicine Department, University of Sherbrooke; T. Khan, MD, Senior Manager Clinician, Clinical Sciences, Pfizer Inc.; P. Bhadra Brown, PhD, Director, Statistics, Pfizer Inc.; A. Clair, PhD, Senior Medical Director, US Medical Affairs, Pfizer Inc.; J.M. Scavone, PharmD, Senior Director; J. Driscoll, PharmD, Director; J. Landen, PhD, Director; L. Pauer, MS, Senior Director, Clinical Sciences, Pfizer Inc.
authors.forename: Andrew
authors.initials: A
authors.lastname: Clair
authors.affiliation: From the Women's Health Research Program, University of Cincinnati College of Medicine, Cincinnati, Ohio; Pfizer Inc., Groton, Connecticut; Pfizer Inc., New York, New York, USA; Reumatologia, Azienda Ospedaliera Polo Universitario L. Sacco, Milan, Italy; Family Medicine Department, University of Sherbrooke, Sherbrooke, Quebec, Canada.L.M. Arnold, MD, Professor of Psychiatry and Behavioral Neuroscience and Director, Women's Health Research Program, University of Cincinnati College of Medicine; P. Sarzi-Puttini, MD, Direttore presso U.O.C., Reumatologia, Azienda Ospedaliera Polo Universitario L. Sacco; P. Arsenault, MD, Associate Professor, Family Medicine Department, University of Sherbrooke; T. Khan, MD, Senior Manager Clinician, Clinical Sciences, Pfizer Inc.; P. Bhadra Brown, PhD, Director, Statistics, Pfizer Inc.; A. Clair, PhD, Senior Medical Director, US Medical Affairs, Pfizer Inc.; J.M. Scavone, PharmD, Senior Director; J. Driscoll, PharmD, Director; J. Landen, PhD, Director; L. Pauer, MS, Senior Director, Clinical Sciences, Pfizer Inc.
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Scavone
authors.affiliation: From the Women's Health Research Program, University of Cincinnati College of Medicine, Cincinnati, Ohio; Pfizer Inc., Groton, Connecticut; Pfizer Inc., New York, New York, USA; Reumatologia, Azienda Ospedaliera Polo Universitario L. Sacco, Milan, Italy; Family Medicine Department, University of Sherbrooke, Sherbrooke, Quebec, Canada.L.M. Arnold, MD, Professor of Psychiatry and Behavioral Neuroscience and Director, Women's Health Research Program, University of Cincinnati College of Medicine; P. Sarzi-Puttini, MD, Direttore presso U.O.C., Reumatologia, Azienda Ospedaliera Polo Universitario L. Sacco; P. Arsenault, MD, Associate Professor, Family Medicine Department, University of Sherbrooke; T. Khan, MD, Senior Manager Clinician, Clinical Sciences, Pfizer Inc.; P. Bhadra Brown, PhD, Director, Statistics, Pfizer Inc.; A. Clair, PhD, Senior Medical Director, US Medical Affairs, Pfizer Inc.; J.M. Scavone, PharmD, Senior Director; J. Driscoll, PharmD, Director; J. Landen, PhD, Director; L. Pauer, MS, Senior Director, Clinical Sciences, Pfizer Inc.
authors.forename: Joseph
authors.initials: J
authors.lastname: Driscoll
authors.affiliation: From the Women's Health Research Program, University of Cincinnati College of Medicine, Cincinnati, Ohio; Pfizer Inc., Groton, Connecticut; Pfizer Inc., New York, New York, USA; Reumatologia, Azienda Ospedaliera Polo Universitario L. Sacco, Milan, Italy; Family Medicine Department, University of Sherbrooke, Sherbrooke, Quebec, Canada.L.M. Arnold, MD, Professor of Psychiatry and Behavioral Neuroscience and Director, Women's Health Research Program, University of Cincinnati College of Medicine; P. Sarzi-Puttini, MD, Direttore presso U.O.C., Reumatologia, Azienda Ospedaliera Polo Universitario L. Sacco; P. Arsenault, MD, Associate Professor, Family Medicine Department, University of Sherbrooke; T. Khan, MD, Senior Manager Clinician, Clinical Sciences, Pfizer Inc.; P. Bhadra Brown, PhD, Director, Statistics, Pfizer Inc.; A. Clair, PhD, Senior Medical Director, US Medical Affairs, Pfizer Inc.; J.M. Scavone, PharmD, Senior Director; J. Driscoll, PharmD, Director; J. Landen, PhD, Director; L. Pauer, MS, Senior Director, Clinical Sciences, Pfizer Inc.
authors.forename: Jaren
authors.initials: J
authors.lastname: Landen
authors.affiliation: From the Women's Health Research Program, University of Cincinnati College of Medicine, Cincinnati, Ohio; Pfizer Inc., Groton, Connecticut; Pfizer Inc., New York, New York, USA; Reumatologia, Azienda Ospedaliera Polo Universitario L. Sacco, Milan, Italy; Family Medicine Department, University of Sherbrooke, Sherbrooke, Quebec, Canada.L.M. Arnold, MD, Professor of Psychiatry and Behavioral Neuroscience and Director, Women's Health Research Program, University of Cincinnati College of Medicine; P. Sarzi-Puttini, MD, Direttore presso U.O.C., Reumatologia, Azienda Ospedaliera Polo Universitario L. Sacco; P. Arsenault, MD, Associate Professor, Family Medicine Department, University of Sherbrooke; T. Khan, MD, Senior Manager Clinician, Clinical Sciences, Pfizer Inc.; P. Bhadra Brown, PhD, Director, Statistics, Pfizer Inc.; A. Clair, PhD, Senior Medical Director, US Medical Affairs, Pfizer Inc.; J.M. Scavone, PharmD, Senior Director; J. Driscoll, PharmD, Director; J. Landen, PhD, Director; L. Pauer, MS, Senior Director, Clinical Sciences, Pfizer Inc.
authors.forename: Lynne
authors.initials: L
authors.lastname: Pauer
mesh_terms: D000328:Adult; D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use*; D000928:Antidepressive Agents / Q000627:therapeutic use*; D018592:Cross-Over Studies; D003866:Depressive Disorder / Q000150:complications / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004347:Drug Interactions; D005260:Female; D005356:Fibromyalgia / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069583:Pregabalin / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D000928:Antidepressive Agents; D000069583:Pregabalin
keywords: DEPRESSION; FIBROMYALGIA; PREGABALIN; SELECTIVE SEROTONIN REUPTAKE INHIBITOR; SEROTONIN/NOREPINEPHRINE REUPTAKE INHIBITOR