title: Tolerability and efficacy of tapentadol extended release in elderly patients ≥ 75 years of age with chronic osteoarthritis knee or low back pain.
abstract: OBJECTIVE
  Management of chronic pain in elderly adult patients is often complicated by analgesic medication-related side effects. This post hoc analysis of pooled data evaluated the tolerability and analgesic efficacy of tapentadol extended release (ER) compared with oxycodone controlled release (CR) in elderly adult patients (≥ 75 years of age) with moderate to severe, chronic osteoarthritis knee or low back pain.
  
  
  METHODS
  Data were pooled from three similarly designed, randomized, doubleblind, placebo- and active-controlled, phase 3 studies of tapentadol ER for moderate to severe, chronic osteoarthritis knee (NCT00421928, NCT00486811) or low back (NCT00449176) pain, and data for patients ≥ 75 years of age were evaluated. Each study consisted of a 3-week titration and 12-week maintenance period. Patients received placebo, tapentadol ER (100-250 mg bid), or oxycodone HCl CR (20-50 mg bid). Tolerability was evaluated using adverse event reporting. Efficacy was evaluated using pain intensity ratings (11-point numerical rating scale).
  
  
  RESULTS
  For patients ≥ 75 years of age (n = 210), incidences of gastrointestinal treatment-emergent adverse events (TEAEs) overall and TEAEs of vomiting and the composite of nausea and/or vomiting were significantly lower in the tapentadol ER group compared with the oxycodone CR group (all p ≤ 0.0206). Tapentadol ER treatment was associated with significant reductions in pain intensity from baseline to week 15 compared with placebo (p = 0.0075); differences between the oxycodone CR and placebo groups failed to reach statistical significance (p = 0.1195), likely related to a higher treatment discontinuation rate in the oxycodone CR group. No significant differences were observed between the tapentadol ER and oxycodone CR groups in the change in pain intensity from baseline to week 15 (p = 0.2135).
  
  
  CONCLUSIONS
  In elderly adult patients ≥ 75 years of age with moderate to severe, chronic osteoarthritis knee or low back pain, tapentadol ER (100-250 mg bid) provided significant pain relief compared with placebo and had a better overall gastrointestinal tolerability profile than oxycodone CR.
authors.affiliation: Therapeutic Area Lead, Neuroscience, Janssen Scientific Affairs, LLC, Raritan, New Jersey.
authors.forename: David M
authors.initials: DM
authors.lastname: Biondi
authors.affiliation: Associate Director, Biostatistics and Programming, Janssen Research & Development, LLC, Raritan, New Jersey.
authors.forename: Jim
authors.initials: J
authors.lastname: Xiang
authors.affiliation: Sr. Director, Compound Development Team Leader, Pain Strategy Deputy Leader, Janssen Research & Development, LLC, Raritan, New Jersey.
authors.forename: Mila
authors.initials: M
authors.lastname: Etropolski
authors.affiliation: Therapeutic Area Lead, Pain, Janssen Scientific Affairs, LLC, Raritan, New Jersey (affiliation at the time of this work).
authors.forename: Bruce
authors.initials: B
authors.lastname: Moskovitz
mesh_terms: D000368:Aged; D002908:Chronic Disease; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004361:Drug Tolerance; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D020370:Osteoarthritis, Knee / Q000188:drug therapy* / Q000503:physiopathology; D059408:Pain Management / Q000379:methods*; D010636:Phenols / Q000008:administration & dosage*; D017450:Receptors, Opioid, mu / Q000819:agonists; D012189:Retrospective Studies; D000077432:Tapentadol; D016896:Treatment Outcome
chemical_list: D003692:Delayed-Action Preparations; D010636:Phenols; D017450:Receptors, Opioid, mu; D000077432:Tapentadol