title: Composite measure to assess efficacy/gastrointestinal tolerability of tapentadol ER versus oxycodone CR for chronic pain: pooled analysis of randomized studies.
abstract: OBJECTIVE
  To evaluate a composite measure for chronic pain that balances pain relief with tolerability.
  
  
  METHODS
  Post hoc meta-analysis of three randomized, multicenter, double-blind studies.
  
  
  METHODS
  Subjects with moderate-to-severe chronic osteoarthritis knee pain or low back pain who had been randomized to receive active treatment with tapentadol extended release (ER; n = 978) or oxycodone controlled release (CR; n = 999). Twenty-two subjects were excluded, mainly because they did not receive treatment.
  
  
  METHODS
  We defined the composite measure as ≥30 percent pain relief without nausea/vomiting/constipation and without discontinuations (≥30 percent PRT [pain relief/tolerability]). We also considered ≥50 percent PRT as well as ≥30 percent and ≥50 percent pain relief without any adverse events of any type. To further evaluate ≥30 percent PRT, we studied its relationship with four patient-reported outcomes: EQ-5D, Physical and Mental Component Summaries of SF-36, Patient Global Impression of Change, and Patient Assessment of Constipation Symptoms.
  
  
  RESULTS
  At week 12, tapentadol ER recipients were more likely to have ≥30 percent PRT than oxycodone CR recipients (OR, 3.15; 95% CI, 2.47, 4.00; p < 0.001). Significant differences were also observed with the other three composite measures (p < 0.001). At week 12, subjects with ≥30 percent PRT had more favorable changes in all patient-reported outcomes than those without and were more likely to have threshold changes in EQ-5D and SF-36 (all p < 0.001).
  
  
  CONCLUSIONS
  Tapentadol ER was associated with significantly better composite outcomes than oxycodone CR. Because both pain relief and gastrointestinal tolerability appeared to be related to outcomes, the composite measure may represent a useful tool for comparing opioids that merits further evaluation.
authors.affiliation: Janssen Global Services, LLC, Raritan, NJ, USA.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Merchant
authors.forename: David
authors.initials: D
authors.lastname: Provenzano
authors.forename: Samir
authors.initials: S
authors.lastname: Mody
authors.forename: Kai Fai
authors.initials: KF
authors.lastname: Ho
authors.forename: Mila
authors.initials: M
authors.lastname: Etropolski
mesh_terms: D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects*; D000704:Analysis of Variance; D002626:Chemistry, Pharmaceutical; D016009:Chi-Square Distribution; D059350:Chronic Pain / Q000175:diagnosis / Q000188:drug therapy*; D017326:Clinical Trials, Phase III as Topic; D003692:Delayed-Action Preparations; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced*; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D016017:Odds Ratio; D010098:Oxycodone / Q000008:administration & dosage / Q000009:adverse effects*; D010147:Pain Measurement; D010636:Phenols / Q000008:administration & dosage / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D012307:Risk Factors; D011795:Surveys and Questionnaires; D000077432:Tapentadol; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D010636:Phenols; D010098:Oxycodone; D000077432:Tapentadol