Low-dose oral prolonged-release oxycodone/naloxone for chronic pain in elderly patients with cognitive impairment: an efficacy–tolerability pilot study
Emiliano Petrò,1 Elena Ruffini,1 Melania Cappuccio,2 Valeria Guerini,2 Gloria Belotti,3 Sara Fascendini,4 Cristina Licini,4 Claudio Marcassa51Rehabiliation and Alzheimer Unit, San Pietro Polyclinic, Ponte San Pietro, 2Alzheimer Center, P. Gusmini Foundation, Vertova, 3Santa Maria Ausiliat...
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Dove Medical Press
2016
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oai:doaj.org-article:60cdf00a51494fd190863e05c41541af2021-12-02T06:24:14ZLow-dose oral prolonged-release oxycodone/naloxone for chronic pain in elderly patients with cognitive impairment: an efficacy–tolerability pilot study1178-2021https://doaj.org/article/60cdf00a51494fd190863e05c41541af2016-03-01T00:00:00Zhttps://www.dovepress.com/low-dose-oral-prolonged-release-oxycodonenaloxone-for-chronic-pain-in--peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Emiliano Petrò,1 Elena Ruffini,1 Melania Cappuccio,2 Valeria Guerini,2 Gloria Belotti,3 Sara Fascendini,4 Cristina Licini,4 Claudio Marcassa51Rehabiliation and Alzheimer Unit, San Pietro Polyclinic, Ponte San Pietro, 2Alzheimer Center, P. Gusmini Foundation, Vertova, 3Santa Maria Ausiliatrice Foundation, Bergamo, 4Alzheimer Center, Briolini Hospital FERB ONLUS, Gazzaniga, 5Cardiology, Maugeri Foundation IRCCS, Veruno, ItalyObjective: 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.Conclusion: 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.Keywords: dementia, Alzheimer’s disease, oxycodone/naloxone, elderly, cognitive impairmentPetrò ERuffini ECappuccio MGuerini VBelotti GFascendini SLicini CMarcassa CDove Medical Pressarticledementiaprolonged-releaseoxycodone/naloxoneelderlycognitive impairmentNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol 2016, Iss Issue 1, Pp 559-569 (2016) |
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DOAJ |
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DOAJ |
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EN |
| topic |
dementia prolonged-release oxycodone/naloxone elderly cognitive impairment Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 |
| spellingShingle |
dementia prolonged-release oxycodone/naloxone elderly cognitive impairment Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Petrò E Ruffini E Cappuccio M Guerini V Belotti G Fascendini S Licini C Marcassa C Low-dose oral prolonged-release oxycodone/naloxone for chronic pain in elderly patients with cognitive impairment: an efficacy–tolerability pilot study |
| description |
Emiliano Petrò,1 Elena Ruffini,1 Melania Cappuccio,2 Valeria Guerini,2 Gloria Belotti,3 Sara Fascendini,4 Cristina Licini,4 Claudio Marcassa51Rehabiliation and Alzheimer Unit, San Pietro Polyclinic, Ponte San Pietro, 2Alzheimer Center, P. Gusmini Foundation, Vertova, 3Santa Maria Ausiliatrice Foundation, Bergamo, 4Alzheimer Center, Briolini Hospital FERB ONLUS, Gazzaniga, 5Cardiology, Maugeri Foundation IRCCS, Veruno, ItalyObjective: 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.Conclusion: 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.Keywords: dementia, Alzheimer’s disease, oxycodone/naloxone, elderly, cognitive impairment |
| format |
article |
| author |
Petrò E Ruffini E Cappuccio M Guerini V Belotti G Fascendini S Licini C Marcassa C |
| author_facet |
Petrò E Ruffini E Cappuccio M Guerini V Belotti G Fascendini S Licini C Marcassa C |
| author_sort |
Petrò E |
| title |
Low-dose oral prolonged-release oxycodone/naloxone for chronic pain in elderly patients with cognitive impairment: an efficacy–tolerability pilot study |
| title_short |
Low-dose oral prolonged-release oxycodone/naloxone for chronic pain in elderly patients with cognitive impairment: an efficacy–tolerability pilot study |
| title_full |
Low-dose oral prolonged-release oxycodone/naloxone for chronic pain in elderly patients with cognitive impairment: an efficacy–tolerability pilot study |
| title_fullStr |
Low-dose oral prolonged-release oxycodone/naloxone for chronic pain in elderly patients with cognitive impairment: an efficacy–tolerability pilot study |
| title_full_unstemmed |
Low-dose oral prolonged-release oxycodone/naloxone for chronic pain in elderly patients with cognitive impairment: an efficacy–tolerability pilot study |
| title_sort |
low-dose oral prolonged-release oxycodone/naloxone for chronic pain in elderly patients with cognitive impairment: an efficacy–tolerability pilot study |
| publisher |
Dove Medical Press |
| publishDate |
2016 |
| url |
https://doaj.org/article/60cdf00a51494fd190863e05c41541af |
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