title: Efficacy and tolerability of low-dose oral prolonged-release oxycodone/naloxone for chronic nononcological pain in older patients.
abstract: OBJECTIVE
  Chronic pain is highly prevalent in older adults. Increasing evidence indicates strong opioids as a valid option for chronic pain management in geriatrics. The aim of this study was to evaluate efficacy and safety of low-dose oral prolonged-release oxycodone-naloxone (OXN-PR) in patients aged ≥70 years.
  
  
  METHODS
  This open-label prospective study assessed older patients naïve to strong opioids presenting with moderate-to-severe chronic pain. Patients were prescribed OXN-PR at an initial dose of 10/5 mg/day for 28 days. In case of insufficient analgesia, the initial daily dose could be increased gradually. The primary efficacy measure was change in pain intensity from baseline, assessed by a ten-point Numeric Rating Scale (NRS) at day 28 (T28). Changes in cognitive state, daily functioning, quality of life, constipation, and other adverse events were assessed.
  
  
  RESULTS
  Of 53 patients enrolled (mean 81.7±6.2 years [range 70-92 years]), 52 (98.1%) completed the 28-day observation. At T28, the primary end point (≥30% reduction in mean pain from baseline in the absence of bowel function deterioration) was achieved in 38 patients (71.7%). OXN-PR significantly relieved pain (NRS score -3.26; P<0.0001), as well as daily need for rescue paracetamol (from 86.8% at baseline to 40.4% at T28; P<0.001), and reduced impact of pain on daily activities (Brief Pain Inventory Short Form from 6.2±1.5 to 3.4±2.1; P<0.0001). OXN-PR was also associated with significant improvement in daily functioning (Barthel Index from 53.3±14.1 to 61.3±14.3; P<0.01). No changes were observed in cognitive status and bowel function. OXN-PR was well tolerated; only one patient (1.9%) prematurely withdrew from treatment, due to drowsiness.
  
  
  CONCLUSIONS
  Findings from this open-label prospective study suggest that low-dose OXN-PR may be effective and well tolerated for treatment of moderate-to-severe chronic pain in older patients. Besides its effectiveness, these data indicate that low-dose OXN-PR may be considered a safe analgesic option in this fragile population and warrants further investigation in randomized controlled studies.
authors.affiliation: Azienda di Servizi alla Persona of Pavia, Istituto di Cura Santa Margherita, Pavia, Italy ; Department of Internal Medicine and Medical Therapy, University of Pavia, Pavia, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Guerriero
authors.affiliation: Department of Internal Medicine and Medical Therapy, University of Pavia, Pavia, Italy.
authors.forename: Carmelo
authors.initials: C
authors.lastname: Sgarlata
authors.affiliation: Fondazione Salvatore Maugeri IRCCS, Veruno, Novara, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Marcassa
authors.affiliation: Azienda di Servizi alla Persona of Pavia, Istituto di Cura Santa Margherita, Pavia, Italy ; Department of Internal Medicine and Medical Therapy, University of Pavia, Pavia, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Ricevuti
authors.affiliation: Azienda di Servizi alla Persona of Pavia, Istituto di Cura Santa Margherita, Pavia, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Rollone
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D059350:Chronic Pain / Q000175:diagnosis / Q000188:drug therapy / Q000209:etiology / Q000523:psychology; D003248:Constipation / Q000139:chemically induced / Q000517:prevention & control; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D009270:Naloxone / Q000008:administration & dosage / Q000009:adverse effects; D010098:Oxycodone / Q000008:administration & dosage / Q000009:adverse effects; D059408:Pain Management; D010147:Pain Measurement; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology*; D016896:Treatment Outcome
chemical_list: D003692:Delayed-Action Preparations; D004338:Drug Combinations; D009270:Naloxone; D010098:Oxycodone
keywords: chronic pain; constipation; elderly; opioid; oxycodone