title: Patient-relevant outcomes and health-related quality of life in patients with chronic, severe, noncancer pain treated with tapentadol prolonged release-Using criteria of health technology assessment.
abstract: To perform a systematic comparison of tapentadol prolonged release (PR) and oxycodone controlled release (CR) using patient-relevant endpoints of efficacy, safety, and health-related quality of life (HRQoL) according to criteria used in health technology assessment. To derive a minimal important difference (MID) for the EQ-5D from three pivotal trials to measure patient-relevant changes in HRQoL.
  
  
  
  Randomized, double-blind, placebo and active controlled.
  
  
  
  Outpatient primary care.
  
  
  
  Patients with severe chronic osteoarthritis pain (two pivotal studies) and severe lower-back pain (one pivotal study) were enrolled. The intent-to-treat population of the three studies comprised a total of 2,968 patients (tapentadol PR arms: 978, oxycodone CR arms: 999, and in the placebo arms: 991).
  
  
  
  Tapentadol PR (100-250 mg bid), oxydodone CR (20-50 mg bid), or placebo over a period of 15 weeks (3 weeks titration plus 12 weeks maintenance).
  
  
  
  Patient-relevant endpoints of efficacy, safety, tolerability, and HRQoL.
  
  
  
  Tapentadol PR demonstrated significant added benefits as compared to oxycodone CR in meta-analyses of the patient-relevant outcomes 30 percent pain relief (Realtive risk [RR]: 0.80 [0.75, 0.87]), treatment discontinuations (RR: 0.55 [0.363, 0.825]), safety (RR: 0.652 [0.599, 0.710]), and HRQoL (RR: 0.78 [0.64, 0.96]) based on a MID derived for the EQ-5D summary index.
  
  
  
  Added benefit of tapentadol in all endpoint categories suggests that it may be beneficial to initiate treatment of chronic severe nonmalignant pain with tapentadol rather than oxycodone.
authors.affiliation: HS Value and Dossier GmbH, Eschborn, Germany.
authors.forename: Johannes Fx
authors.initials: JF
authors.lastname: Hofmann
authors.affiliation: Gruenenthal GmbH, Aachen, Germany.
authors.forename: Arun
authors.initials: A
authors.lastname: Lal
authors.affiliation: Health Economist, Gruenenthal GmbH, Aachen, Germany.
authors.forename: Maike
authors.initials: M
authors.lastname: Steffens
authors.affiliation: Health Economist, Gruenenthal GmbH, Aachen, Germany.
authors.forename: Robert
authors.initials: R
authors.lastname: Boettger
mesh_terms: D000553:Ambulatory Care; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001416:Back Pain / Q000188:drug therapy*; D059350:Chronic Pain / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010636:Phenols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D012372:ROC Curve; D012720:Severity of Illness Index; D000077432:Tapentadol; D013673:Technology Assessment, Biomedical; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D010636:Phenols; D000077432:Tapentadol