title: Switching to low-dose oral prolonged-release oxycodone/naloxone from WHO-Step I drugs in elderly patients with chronic pain at high risk of early opioid discontinuation.
abstract: OBJECTIVE
  Chronic pain has a high prevalence in the aging population. Strong opioids also should be considered in older people for the treatment of moderate to severe pain or for pain that impairs functioning and the quality of life. This study aimed to assess the efficacy and safety of the direct switch to low-dose strong opioids (World Health Organization-Step III drugs) in elderly, opioid-naive patients.
  
  
  METHODS
  This was a single-center, retrospective, observational study in opioid-naive patients aged ≥75 years, with moderate to severe chronic pain (>6-month duration) and constipation, who initiated treatment with prolonged-release oxycodone/naloxone (OXN-PR). Patients were re-evaluated after 15, 30, and 60 days (T60, final observation). Response to treatment was defined as an improvement in pain of ≥30% after 30 days of therapy without worsening of constipation.
  
  
  RESULTS
  One-hundred and eighty-six patients (mean ± SD age 80.7±4.7 years; 64.5% women) with severe chronic pain (mean average pain intensity 7.1±1.0 on the 11-point numerical rating scale) and constipation (mean Bowel Function Index 64.1±24.4; 89.2% of patients on laxatives) were initiated treatment with OXN-PR (mean daily dose 11.3±3.5 mg). OXN-PR reduced pain intensity rapidly and was well tolerated; 63.4% of patients responded to treatment with OXN-PR. At T60 (mean daily OXN-PR dose, 21.5±9.7 mg), the pain intensity was reduced by 66.7%. In addition, bowel function improved (mean decrease of Bowel Function Index from baseline to T60, -28.2, P<0.0001) and the use of laxatives decreased. Already after 15 days and throughout treatment, ~70% of patients perceived their status as much/extremely improved. Only 1.6% of patients discontinued treatment due to adverse events.
  
  
  CONCLUSIONS
  Low-dose OXN-PR in elderly patients naive to opioids proved to be an effective option for the treatment of moderate to severe chronic pain. Large-scale trials are needed to improve clinical guidance in the assessment and treatment of pain in older people.
authors.affiliation: Department of Emergency and Critical Care Medicine, Pain Medicine and Anaesthesiology, Tor Vergata Polyclinic, University of Rome, Rome, Italy.
authors.forename: Marzia
authors.initials: M
authors.lastname: Lazzari
authors.affiliation: Cardiology Division, Fondazione Maugeri IRCCS Veruno, Novara, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Marcassa
authors.affiliation: Department of Emergency and Critical Care Medicine, Pain Medicine and Anaesthesiology, Tor Vergata Polyclinic, University of Rome, Rome, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Natoli
authors.affiliation: Department of Emergency and Critical Care Medicine, Pain Medicine and Anaesthesiology, Tor Vergata Polyclinic, University of Rome, Rome, Italy.
authors.forename: Roberta
authors.initials: R
authors.lastname: Carpenedo
authors.affiliation: Department of Emergency and Critical Care Medicine, Pain Medicine and Anaesthesiology, Tor Vergata Polyclinic, University of Rome, Rome, Italy.
authors.forename: Clarissa
authors.initials: C
authors.lastname: Caldarulo
authors.affiliation: Department of Emergency and Critical Care Medicine, Pain Medicine and Anaesthesiology, Tor Vergata Polyclinic, University of Rome, Rome, Italy.
authors.forename: Maria B
authors.initials: MB
authors.lastname: Silvi
authors.affiliation: Department of Emergency and Critical Care Medicine, Pain Medicine and Anaesthesiology, Tor Vergata Polyclinic, University of Rome, Rome, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Dauri
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000009:adverse effects*; D059350:Chronic Pain / Q000188:drug therapy*; D003248:Constipation / Q000139:chemically induced*; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D009270:Naloxone / Q000008:administration & dosage* / Q000009:adverse effects; D010098:Oxycodone / Q000008:administration & dosage* / Q000009:adverse effects; D010147:Pain Measurement; D011788:Quality of Life; D012189:Retrospective Studies; D012720:Severity of Illness Index
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D009270:Naloxone; D010098:Oxycodone
keywords: chronic pain; elderly; naloxone; opioid; oxycodone