title: Evaluation of study discontinuations with tapentadol inmmediate release and oxycodone immediate release in patients with low back or osteoarthritis pain.
abstract: OBJECTIVE
  To examine discontinuations due to nausea and/or vomiting or constipation with tapentadol immediate release (IR) or oxycodone IR treatment.
  
  
  METHODS
  Post hoc analyses of a 90-day, phase 3, randomized, double-blind, flexible-dose study.
  
  
  METHODS
  United States, Canada, United Kingdom.
  
  
  METHODS
  Adults with moderate to severe low back or osteoarthritis (OA) pain for > or =3 months.
  
  
  METHODS
  Tapentadol IR 50 or 100 mg or oxycodone HCI IR 10 or 15 mg every 4-6 hours as needed.
  
  
  METHODS
  Adverse events and discontinuations were recorded.
  
  
  RESULTS
  Post hoc analyses included data from 679 patients receiving tapentadol IR and 170 receiving oxycodone IR (4:1 randomization). Tapentadol IR 50 or 100 mg and oxycodone HCI IR 10 or 15 mg provided similar levels of pain relief Overall, 21.2 percent of patients receiving tapentadol IR discontinued treatment for adverse events versus 31.2 percent of patients receiving oxycodone IR. The percentage of patients who discontinued for nausea and/or vomiting was significantly lower with tapentadol IR (5.9 percent) than oxycodone IR (14.7 percent; p = 0.0003); patients treated with oxycodone IR discontinued because of nausea and/or vomiting significantly earlier than with tapentadol IR (p < 0.0001). The percentage of patients who discontinued because of constipation was significantly lower with tapentadol IR (1.5 percent) than with oxycodone IR (5.9 percent; p = 0.0023); patients treated with oxycodone IR discontinued because of constipation significantly earlier versus tapentadol IR (p = 0.0003).
  
  
  CONCLUSIONS
  A lower percentage of patients discontinued because of nausea and/or vomiting or constipation with tapentadol IR versus oxycodone IR while receiving comparable pain relief suggesting tapentadol may improve the management of low back and OA pain.
authors.affiliation: Clinical Development, Ortho-McNeil Janssen Scientific Affairs, LLC, Raritan, New Jersey, USA.
authors.forename: Gary
authors.initials: G
authors.lastname: Vorsanger
authors.forename: Jim
authors.initials: J
authors.lastname: Xiang
authors.forename: Akiko
authors.initials: A
authors.lastname: Okamoto
authors.forename: David
authors.initials: D
authors.lastname: Upmalis
authors.forename: Bruce
authors.initials: B
authors.lastname: Moskovitz
mesh_terms: D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010003:Osteoarthritis / Q000188:drug therapy*; D010098:Oxycodone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010636:Phenols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017450:Receptors, Opioid, mu / Q000819:agonists*; D000077432:Tapentadol; D014839:Vomiting / Q000139:chemically induced
chemical_list: D000701:Analgesics, Opioid; D010636:Phenols; D017450:Receptors, Opioid, mu; D010098:Oxycodone; D000077432:Tapentadol