title: Low-dose oral prolonged-release oxycodone/naloxone for chronic pain in elderly patients with cognitive impairment: an efficacy-tolerability pilot study.
abstract: OBJECTIVE
  This pilot study evaluated the efficacy and safety of prolonged-release oxycodone/naloxone (OXN-PR) in older subjects with chronic pain and mild-to-moderate cognitive impairment.
  
  
  METHODS
  This was a prospective, observational, open-label study of 45-day duration. Patients with moderate-to-severe chronic pain and naïve to strong opioids were recruited from nursing homes and Alzheimer's disease centers. OXN-PR was initiated at low doses (5 mg od or bid) and increased to a maximum of 20 mg bid. The primary efficacy endpoint was a pain intensity reduction of ≥30% from baseline (T0) to 15 days after OXN-PR initiation, as assessed by a numerical rating scale or the Pain Assessment in Advanced Dementia scale. Other assessments included the Barthel activities of daily living index, Neuropsychiatric Inventory, Bowel Function Index, and adverse events.
  
  
  RESULTS
  The analysis included 53 patients (mean age, 83.0 years; mean Mini-Mental State Examination score, 18.6) with severe pain (median Numerical Rating Scale/Pain Assessment in Advanced Dementia 6) and substantial impairment in daily functioning (mean Barthel index, 32.2). The primary endpoint was achieved by 92.4% of patients. OXN-PR significantly reduced mean pain intensity from baseline to study end (numerical rating scale, 6.6±1.0 vs 2.3±1.1, P<0.0001; Pain Assessment in Advanced Dementia, 6.9±1.6 vs 0.9±0.8, P<0.0001). Substantial improvements from T0 to T45 in daily functioning (mean Barthel index, 32.2±16.8 vs 53.7±23.9, P<0.0001) and neuropsychiatric symptoms (mean Neuropsychiatric Inventory, 25.5±27.3 vs 8.8±9.0, P<0.0001) were also reported. OXN-PR was well tolerated and did not worsen bowel function.
  
  
  CONCLUSIONS
  In this pilot study, OXN-PR was effective in improving pain and other symptoms associated with dementia, with a favorable safety and tolerability profile. Large-scale trials in people with dementia are needed to improve clinical guidance for the assessment and treatment of pain in these fragile individuals.
authors.affiliation: Rehabiliation and Alzheimer Unit, San Pietro Polyclinic, Ponte San Pietro, Italy.
authors.forename: Emiliano
authors.initials: E
authors.lastname: Petrò
authors.affiliation: Rehabiliation and Alzheimer Unit, San Pietro Polyclinic, Ponte San Pietro, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Ruffini
authors.affiliation: Alzheimer Center, P. Gusmini Foundation, Vertova, Italy.
authors.forename: Melania
authors.initials: M
authors.lastname: Cappuccio
authors.affiliation: Alzheimer Center, P. Gusmini Foundation, Vertova, Italy.
authors.forename: Valeria
authors.initials: V
authors.lastname: Guerini
authors.affiliation: Santa Maria Ausiliatrice Foundation, Bergamo, Italy.
authors.forename: Gloria
authors.initials: G
authors.lastname: Belotti
authors.affiliation: Alzheimer Center, Briolini Hospital FERB ONLUS, Gazzaniga, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Fascendini
authors.affiliation: Alzheimer Center, Briolini Hospital FERB ONLUS, Gazzaniga, Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Licini
authors.affiliation: Cardiology, Maugeri Foundation IRCCS, Veruno, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Marcassa
keywords: Alzheimer’s disease; cognitive impairment; dementia; elderly; oxycodone/naloxone