title: Efficacy and safety of tapentadol prolonged release for chronic osteoarthritis pain and low back pain.
abstract: BACKGROUND
  This pooled analysis of data from three phase 3 studies in patients with chronic osteoarthritis knee or low back pain evaluated the efficacy and tolerability of tapentadol prolonged release (PR; 100-250 mg twice daily) compared with placebo and oxycodone hydrochloride (HCl) controlled release (CR; 20-50 mg twice daily).
  
  
  METHODS
  Patients in each study were randomized to receive twice-daily doses of placebo, tapentadol PR (100-250 mg), or oxycodone HCl CR (20-50 mg) for a 12-week maintenance period, preceded by a 3-week titration period. Primary endpoints were change from baseline in average pain intensity (11-point numeric rating scale) at week 12 of the maintenance period and for the overall maintenance period using last observation carried forward for imputation of values missing after treatment discontinuation.
  
  
  RESULTS
  A total of 2968 patients were evaluated for efficacy; 2974 patients were evaluated for safety. Compared with placebo, treatment with tapentadol PR or oxycodone CR resulted in significantly greater reductions in pain intensity from baseline at week 12 and for the overall maintenance period (all P<0.001). For both primary endpoints, the efficacy of tapentadol PR was noninferior to oxycodone CR (P<0.001), and tapentadol PR had superior gastrointestinal tolerability compared with oxycodone CR (P<0.001). Results of analyses of responders, patient global impression of change, Short Form-36 domains (except general health), and the EuroQol 5-Dimension health status index were significantly better for tapentadol PR than oxycodone CR (all P<or=0.048); these results may have been affected by the worse tolerability profile of oxycodone CR. A higher percentage of patients discontinued treatment with oxycodone CR (61.7% [616/999]) compared with tapentadol PR (43.5% [425/978]).
  
  
  CONCLUSIONS
  Tapentadol PR (100-250 mg twice daily) was efficacious and provided efficacy that was similar to oxycodone HCl CR (20-50 mg twice daily) for the management of chronic osteoarthritis knee and low back pain, with a superior gastrointestinal tolerability profile and fewer treatment discontinuations.
authors.affiliation: Global Development, Grünenthal GmbH, D-52078 Aachen, Germany. bernd.lange@grunenthal.com
authors.forename: Bernd
authors.initials: B
authors.lastname: Lange
authors.forename: Brigitte
authors.initials: B
authors.lastname: Kuperwasser
authors.forename: Akiko
authors.initials: A
authors.lastname: Okamoto
authors.forename: Achim
authors.initials: A
authors.lastname: Steup
authors.forename: Thomas
authors.initials: T
authors.lastname: Häufel
authors.forename: Judy
authors.initials: J
authors.lastname: Ashworth
authors.forename: Mila
authors.initials: M
authors.lastname: Etropolski
mesh_terms: D000368:Aged; D000701:Analgesics, Opioid / Q000627:therapeutic use; D000704:Analysis of Variance; D002908:Chronic Disease; D017326:Clinical Trials, Phase III as Topic; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D016018:Least-Squares Analysis; D017116:Low Back Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D010098:Oxycodone / Q000627:therapeutic use; D010147:Pain Measurement; D010636:Phenols / Q000494:pharmacology / Q000627:therapeutic use*; D011788:Quality of Life / Q000523:psychology; D016032:Randomized Controlled Trials as Topic; D012449:Safety; D012720:Severity of Illness Index; D000077432:Tapentadol; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D010636:Phenols; D010098:Oxycodone; D000077432:Tapentadol