title: Impact of prolonged-release oxycodone/naloxone on outcomes affecting patients' daily functioning in comparison with extended-release tapentadol: a systematic review.
abstract: OBJECTIVE
  The objective of this systematic review was to assess the clinical efficacy, safety, tolerability, and health-related quality of life outcomes associated with management of moderate-to-severe chronic pain with oxycodone/naloxone and tapentadol, focusing on the effect of these treatments on patients' daily functioning.
  
  
  METHODS
  Literature from a wide range of sources, including Embase, MEDLINE, MEDLINE In-Process, and the Cochrane Central Register of Controlled Trials, was searched to identify randomized controlled trials investigating tapentadol or oxycodone/naloxone for the treatment of patients with chronic pain. A network meta-analysis was conducted to determine the relative efficacy and safety profiles of these treatments.
  
  
  RESULTS
  Oxycodone/naloxone was significantly better than tapentadol with respect to the Patient Assessment of Constipation Symptoms total score (risk ratio = -3.60; 95% credible interval, -5.36 to -2.11) and revealed a significantly lower risk of dizziness (risk ratio = 0.72; 95% credible interval, 0.42-0.98). Oxycodone/naloxone was directionally favored, although not significantly superior to tapentadol for headache, fatigue, dry mouth, dyspepsia, and withdrawals due to lack of efficacy. For the AE outcomes of constipation, nausea, and vomiting, as well as pain efficacy and all-cause withdrawals from studies, tapentadol was directionally favored without any statistical difference from oxycodone/naloxone. However, the two treatments were not wholly comparable for the evaluation of pain efficacy because of differences in on-study rescue medication and a higher baseline pain severity in the tapentadol studies.
  
  
  CONCLUSIONS
  Oxycodone/naloxone offers significant improvements in Patient Assessment of Constipation Symptoms total score and dizziness and was directionally favored for fatigue and headache compared with extended-release tapentadol, which may translate to improved patient daily functioning and health-related quality of life.
authors.affiliation: HERON Commercialization, PAREXEL Consulting, Chandigarh, India.
authors.forename: Deepika
authors.initials: D
authors.lastname: Thakur
authors.affiliation: Napp Pharmaceuticals Ltd, Cambridge, United Kingdom. Electronic address: Sara.Dickerson@napp.co.uk.
authors.forename: Sara
authors.initials: S
authors.lastname: Dickerson
authors.affiliation: HERON Commercialization, PAREXEL Consulting, Chandigarh, India.
authors.forename: Mohit
authors.initials: M
authors.lastname: Kumar Bhutani
authors.affiliation: Napp Pharmaceuticals Ltd, Cambridge, United Kingdom.
authors.forename: Rod
authors.initials: R
authors.lastname: Junor
mesh_terms: D059350:Chronic Pain / Q000188:drug therapy; D003248:Constipation / Q000139:chemically induced; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D004338:Drug Combinations; D006261:Headache / Q000139:chemically induced; D006801:Humans; D009270:Naloxone / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D009325:Nausea / Q000139:chemically induced; D010098:Oxycodone / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D010636:Phenols / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D011788:Quality of Life; D000077432:Tapentadol; D014839:Vomiting / Q000139:chemically induced
chemical_list: D003692:Delayed-Action Preparations; D004338:Drug Combinations; D010636:Phenols; D009270:Naloxone; D010098:Oxycodone; D000077432:Tapentadol
keywords: chronic pain; constipation; dizziness; oxycodone/naloxone; tapentadol