title: Effectiveness and Tolerability of a Moderate Dose of Tapentadol Prolonged Release for Managing Severe, Chronic Low Back Pain with a Neuropathic Component: An Open-label Continuation Arm of a Randomized Phase 3b Study.
abstract: OBJECTIVE
  To evaluate the effectiveness and tolerability of tapentadol prolonged release (PR) for severe, chronic low back pain with a neuropathic component in a subpopulation that achieved adequate pain relief with tapentadol PR 300 mg/day in a randomized, double-blind, phase 3b study.
  
  
  METHODS
  Patients with painDETECT "unclear" or "positive" ratings and pain intensity ≥ 6 (11-point NRS-3 [average 3-day pain intensity]) were titrated to tapentadol PR 300 mg/day over 3 weeks. A subpopulation with pain intensity < 4 continued receiving tapentadol PR 300 mg/day during an 8-week, open-label continuation arm. For the primary study population, patients with ≥ 1-point decrease from baseline and pain intensity ≥ 4 were randomized to tapentadol PR 500 mg/day or tapentadol PR 300 mg/day plus pregabalin 300 mg/day during a concurrent 8-week, double-blind comparative period.
  
  
  RESULTS
  From baseline to end of titration and to final evaluation, significant improvements were observed in pain intensity (mean [SD] changes from baseline to: end of titration; - 5.3 [1.78]; final evaluation; - 5.2 [2.39]; both P < 0.0001), neuropathic pain symptoms, and quality-of-life measures in the open-label continuation arm, with greater improvements in this selected subpopulation than in either group in the primary study population. A favorable tolerability profile was observed, with incidences of all individual treatment-emergent adverse events ≤ 5.1% during the continuation period.
  
  
  CONCLUSIONS
  A subpopulation of patients with low back pain with a neuropathic component responded very well to tapentadol PR 300 mg/day, with significant improvements in pain intensity, neuropathic pain-related symptoms, and quality of life. Further research is needed to identify factors associated with a very positive treatment response.
authors.affiliation: Division of Neurological Pain Research and Therapy, Department of Neurology University Hospital of Schleswig-Holstein, Campus Kiel, Kiel, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Baron
authors.affiliation: Institute of Pain Medicine/Pain Practice, Wiesbaden, Germany.
authors.forename: Uwe
authors.initials: U
authors.lastname: Kern
authors.affiliation: Medical Affairs Europe & Australia, Grünenthal GmbH, Aachen, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Müller
authors.affiliation: Global Biometrics in Grünenthal Innovation, Grünenthal GmbH, Aachen, Germany.
authors.forename: Cecile
authors.initials: C
authors.lastname: Dubois
authors.affiliation: Medical Affairs Europe & Australia, Grünenthal GmbH, Aachen, Germany.
authors.forename: Dietmar
authors.initials: D
authors.lastname: Falke
authors.affiliation: Medical Affairs Europe & Australia, Grünenthal GmbH, Aachen, Germany.
authors.forename: Ilona
authors.initials: I
authors.lastname: Steigerwald
mesh_terms: D000328:Adult; D000368:Aged; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009437:Neuralgia / Q000175:diagnosis / Q000188:drug therapy*; D059408:Pain Management / Q000379:methods*; D010636:Phenols / Q000008:administration & dosage*; D011788:Quality of Life; D012720:Severity of Illness Index; D000077432:Tapentadol; D016896:Treatment Outcome
chemical_list: D003692:Delayed-Action Preparations; D010636:Phenols; D000077432:Tapentadol
keywords: chronic pain; low back pain; neuropathic pain; tapentadol prolonged release; tolerability