title: Post hoc analyses of data from a 90-day clinical trial evaluating the tolerability and efficacy of tapentadol immediate release and oxycodone immediate release for the relief of moderate to severe pain in elderly and nonelderly patients.
abstract: OBJECTIVE
  To evaluate the tolerability and efficacy of tapentadol immediate release (IR) and oxycodone IR for relief of moderate to severe pain in elderly and nonelderly patients.
  
  
  METHODS
  Post hoc data analyses were conducted on a 90-day randomized, phase 3, double-blind, flexible-dose study (ClinicalTrials.gov: NCT00364546) of adults with moderate to severe lower back pain or osteoarthritis pain who received tapentadol IR 50 mg or 100 mg, or oxycodone HCl IR 10 mg or 15 mg every 4 h to 6 h as needed for pain relief. Treatment-emergent adverse events and study discontinuations were recorded.
  
  
  RESULTS
  Data from 849 patients randomly assigned (4:1 ratio) to treatment with a study drug (tapentadol IR [n=679] or oxycodone IR [n=170]) were analyzed according to age (younger than 65 years of age [nonelderly], or 65 years of age or older [elderly]) and treatment group. Among elderly patients, incidences of constipation (19.0% versus 35.6%) and nausea or vomiting (30.4% versus 51.1%) were significantly lower with tapentadol IR versus oxycodone IR (all P<0.05). Initial onsets of nausea and constipation occurred significantly later with tapentadol IR versus oxycodone IR (both P<=0.031). Tapentadol IR-treated elderly patients had a lower percentage of days with constipation than oxycodone IR-treated patients (P=0.020). For tapentadol IR- and oxycodone IR-treated elderly patients, respectively, incidences of study discontinuation due to gastrointestinal treatment-emergent adverse events were 15.8% and 24.4% (P=0.190). Tapentadol IR and oxycodone IR provided similar pain relief, with no overall age-dependent efficacy differences (mean pain scores [11-point numerical rating scale] decreased from 7.0 and 7.2 at baseline, to 4.9 and 5.2 at end point, respectively).
  
  
  CONCLUSIONS
  Tapentadol IR was safe and effective for the relief of lower back pain and osteoarthritis pain in elderly patients, and was associated with a better gastrointestinal tolerability profile than oxycodone IR.
authors: Janssen Scientific Affairs, LLC, Raritan, New Jersey, USA. gvorsang@its.jnj.com
authors: Gary
authors: G
authors: Vorsanger
authors: Jim
authors: J
authors: Xiang
authors: David
authors: D
authors: Biondi
authors: David
authors: D
authors: Upmalis
authors: Jacqueline
authors: J
authors: Delfgaauw
authors: René
authors: R
authors: Allard
authors: Bruce
authors: B
authors: Moskovitz
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003248:Constipation / Q000139:chemically induced; D004338:Drug Combinations; D004361:Drug Tolerance; D006801:Humans; D008875:Middle Aged; D010003:Osteoarthritis / Q000150:complications; D010098:Oxycodone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010636:Phenols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077432:Tapentadol; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D004338:Drug Combinations; D010636:Phenols; D010098:Oxycodone; D000077432:Tapentadol