title: A pooled analysis of patient-specific factors and efficacy and tolerability of tapentadol extended release treatment for moderate to severe chronic pain.
abstract: OBJECTIVE
  To evaluate via retrospective analysis the efficacy and tolerability of tapentadol extended release (ER; 100-250 mg bid) based on patient-specific factors, including baseline pain intensity, prior opioid experience, gender, and body mass index (BMI).
  
  
  METHODS
  Data were pooled from three randomized, double-blind phase III studies of similar design that evaluated the efficacy and tolerability of tapentadol ER for the management of moderate to severe, chronic osteoarthritis knee pain (NCT00421928, NCT00486811) or low back pain (NCT00449176).
  
  
  METHODS
  In the original trials, patients were recruited at primary, secondary, and tertiary care centers, institutional settings, and private practices in North America, Europe, Australia, and New Zealand.
  
  
  METHODS
  Data were analyzed separately for groups of patients divided by baseline pain intensity, prior opioid experience, gender, and BMI.
  
  
  METHODS
  Patients received twice-daily placebo, tapentadol ER (100-250 mg), or oxycodone HCl controlled release (CR; 20-50 mg) for a 3-week titration and 12-week maintenance period.
  
  
  METHODS
  Changes from baseline in average pain intensity (11-point numerical rating scale) at week 12 of the maintenance period and for the overall maintenance period.
  
  
  RESULTS
  Efficacy and tolerability were evaluated in 2,968 and 2,974 patients, respectively. The efficacy of tapentadol ER was shown in subpopulations divided by baseline pain intensity, prior opioid experience, gender, and BMI. Tapentadol ER was also shown to be well tolerated and associated with better gastrointestinal tolerability than oxycodone CR in the evaluated subpopulations (divided by prior opioid experience and gender).
  
  
  CONCLUSIONS
  Results suggest that tapentadol ER (100-250 mg bid) provides similar pain relief and tolerability, regardless of baseline pain intensity, prior opioid experience, gender, or BMI.
authors.affiliation: Senior Director/Clinical Leader, Janssen Research & Development, LLC, Raritan, New Jersey.
authors.forename: Mila
authors.initials: M
authors.lastname: Etropolski
authors.affiliation: Associate International Clinical Lead, Grünenthal GmbH, Aachen, Germany.
authors.forename: Bernd
authors.initials: B
authors.lastname: Lange
authors.affiliation: Associate International Clinical Lead, Grünenthal GmbH, Aachen, Germany.
authors.forename: Jutta
authors.initials: J
authors.lastname: Goldberg
authors.affiliation: Dipl.-Stat., Project Biostatistician, Global Biometrics-Biostatistics, Grünenthal GmbH, Aachen, Germany.
authors.forename: Achim
authors.initials: A
authors.lastname: Steup
authors.affiliation: Vice President/Compound Development Team Leader, Janssen Research & Development, LLC, Raritan, New Jersey.
authors.forename: Christine
authors.initials: C
authors.lastname: Rauschkolb
mesh_terms: D000700:Analgesics / Q000627:therapeutic use*; D015992:Body Mass Index; D059350:Chronic Pain / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy; D008297:Male; D010003:Osteoarthritis / Q000188:drug therapy; D010636:Phenols / Q000009:adverse effects / Q000627:therapeutic use*; D000077432:Tapentadol
chemical_list: D000700:Analgesics; D003692:Delayed-Action Preparations; D010636:Phenols; D000077432:Tapentadol