title: Prolonged-release oxycodone/naloxone in opioid-naïve patients - subgroup analysis of a prospective observational study.
abstract: OBJECTIVE
  Prolonged-release oxycodone/naloxone (OXN PR) showed improved gastrointestinal tolerability and equivalent analgesic efficacy compared to oxycodone alone in patients with non-cancer pain or cancer pain. This is the first dataset to demonstrate its effectiveness and safety compared to other strong opioids in opioid-naïve patients.
  
  
  METHODS
  This is a subgroup analysis of a 4- to 6-week multicenter, observational study. A total of 162 opioid-naïve patients with moderate-to-severe pain of varying etiologies received either OXN PR or other strong opioids (control group). Documented parameters include pain relief (numeric rating scale), bowel function (Bowel Function Index [BFI]), pain-related functional impairment (Brief Pain Inventory Short Form), quality of life (QoL; EuroQol EQ-5D-3L) and a global therapy assessment.
  
  
  RESULTS
  OXN group patients experienced a substantial clinically important reduction in mean pain intensity of 51.4%, compared to a 28.6% reduction in control patients. Although the BFI remained in the reference range in both groups, there was a difference between BFI changes during treatment in favor of OXN PR. The superior effectiveness of OXN PR was paralleled by greater improvements of pain interference and QoL and fewer adverse drug reactions compared to other strong opioids.
  
  
  CONCLUSIONS
  The favorable outcomes under real-life conditions suggest that OXN PR provides a valuable option for treatment of moderate-to-severe pain without using weak opioids first.
authors.affiliation: Regionales Schmerz- und PalliativZentrum DGS Mainz , Mainz, Rheinstraße 4 F/ Fort Malakoff, 55116 Mainz , Germany +49 6131 6693401 ; +49 6131 6693402 ; sabinehesselbarth@t-online.de.
authors.forename: Sabine
authors.initials: S
authors.lastname: Hesselbarth
authors.forename: Kai
authors.initials: K
authors.lastname: Hermanns
authors.forename: Petra
authors.initials: P
authors.lastname: Oepen
mesh_terms: D000368:Aged; D003248:Constipation / Q000209:etiology / Q000517:prevention & control; D003672:Defecation / Q000187:drug effects; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009270:Naloxone / Q000009:adverse effects / Q000627:therapeutic use*; D009294:Narcotics / Q000009:adverse effects / Q000627:therapeutic use*; D009369:Neoplasms / Q000150:complications / Q000503:physiopathology; D010098:Oxycodone / Q000009:adverse effects / Q000627:therapeutic use*; D010146:Pain / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D059408:Pain Management; D011446:Prospective Studies; D011788:Quality of Life
chemical_list: D003692:Delayed-Action Preparations; D004338:Drug Combinations; D009294:Narcotics; C557247:oxycodone naloxone combination; D009270:Naloxone; D010098:Oxycodone
keywords: naloxone; opioid; opioid-induced bowel dysfunction; oxycodone; pain; quality of life