Low-dose oral prolonged-release oxycodone/naloxone for chronic pain in elderly patients with cognitive impairment: An efficacy–tolerability pilot study

Emiliano Petrò, Elena Ruffini, Melania Cappuccio, Valeria Guerini, Gloria Belotti, Sara Fascendini, Cristina Licini, Claudio Marcassa

Research output: Contribution to journalArticlepeer-review

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

Original languageEnglish
Pages (from-to)559-569
Number of pages11
JournalNeuropsychiatric Disease and Treatment
Volume12
DOIs
Publication statusPublished - Mar 2 2016

Keywords

  • Alzheimer’s disease
  • Cognitive impairment
  • Dementia
  • Elderly
  • Oxycodone/naloxone

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Biological Psychiatry

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