Composite measure to assess efficacy/gastrointestinal tolerability of tapentadol ER versus oxycodone CR for chronic pain: pooled analysis of randomized studies

J Opioid Manag. Jan-Feb 2013;9(1):51-61. doi: 10.5055/jom.2013.0147.

Abstract

Objective: To evaluate a composite measure for chronic pain that balances pain relief with tolerability.

Design: Post hoc meta-analysis of three randomized, multicenter, double-blind studies.

Participants: 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.

Main outcome measures: 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.

Trial registration: ClinicalTrials.gov NCT00421928 NCT00449176 NCT00486811.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Analgesics, Opioid / administration & dosage
  • Analgesics, Opioid / adverse effects*
  • Analysis of Variance
  • Chemistry, Pharmaceutical
  • Chi-Square Distribution
  • Chronic Pain / diagnosis
  • Chronic Pain / drug therapy*
  • Clinical Trials, Phase III as Topic
  • Delayed-Action Preparations
  • Female
  • Gastrointestinal Diseases / chemically induced*
  • Humans
  • Logistic Models
  • Male
  • Middle Aged
  • Multicenter Studies as Topic
  • Odds Ratio
  • Oxycodone / administration & dosage
  • Oxycodone / adverse effects*
  • Pain Measurement
  • Phenols / administration & dosage
  • Phenols / adverse effects*
  • Randomized Controlled Trials as Topic
  • Risk Assessment
  • Risk Factors
  • Surveys and Questionnaires
  • Tapentadol
  • Treatment Outcome

Substances

  • Analgesics, Opioid
  • Delayed-Action Preparations
  • Phenols
  • Oxycodone
  • Tapentadol

Associated data

  • ClinicalTrials.gov/NCT00421928
  • ClinicalTrials.gov/NCT00449176
  • ClinicalTrials.gov/NCT00486811