A pooled analysis of patient-specific factors and efficacy and tolerability of tapentadol extended release treatment for moderate to severe chronic pain

J Opioid Manag. Sep-Oct 2013;9(5):343-56. doi: 10.5055/jom.2013.0177.

Abstract

Objective: To evaluate via retrospective analysis the efficacy and tolerability of tapentadol extended release (ER; 100-250 mg bid) based on patient-specific factors, including baseline pain intensity, prior opioid experience, gender, and body mass index (BMI).

Design: Data were pooled from three randomized, double-blind phase III studies of similar design that evaluated the efficacy and tolerability of tapentadol ER for the management of moderate to severe, chronic osteoarthritis knee pain (NCT00421928, NCT00486811) or low back pain (NCT00449176).

Setting: In the original trials, patients were recruited at primary, secondary, and tertiary care centers, institutional settings, and private practices in North America, Europe, Australia, and New Zealand.

Patients: Data were analyzed separately for groups of patients divided by baseline pain intensity, prior opioid experience, gender, and BMI.

Interventions: Patients received twice-daily placebo, tapentadol ER (100-250 mg), or oxycodone HCl controlled release (CR; 20-50 mg) for a 3-week titration and 12-week maintenance period.

Main outcome measures: Changes from baseline in average pain intensity (11-point numerical rating scale) at week 12 of the maintenance period and for the overall maintenance period.

Results: Efficacy and tolerability were evaluated in 2,968 and 2,974 patients, respectively. The efficacy of tapentadol ER was shown in subpopulations divided by baseline pain intensity, prior opioid experience, gender, and BMI. Tapentadol ER was also shown to be well tolerated and associated with better gastrointestinal tolerability than oxycodone CR in the evaluated subpopulations (divided by prior opioid experience and gender).

Conclusions: Results suggest that tapentadol ER (100-250 mg bid) provides similar pain relief and tolerability, regardless of baseline pain intensity, prior opioid experience, gender, or BMI.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Analgesics / therapeutic use*
  • Body Mass Index
  • Chronic Pain / drug therapy*
  • Delayed-Action Preparations
  • Double-Blind Method
  • Female
  • Humans
  • Low Back Pain / drug therapy
  • Male
  • Osteoarthritis / drug therapy
  • Phenols / adverse effects
  • Phenols / therapeutic use*
  • Tapentadol

Substances

  • Analgesics
  • Delayed-Action Preparations
  • Phenols
  • Tapentadol

Associated data

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