Evidence map›Paper›PMID 27042069›Full record

ArticleNeuropsychiatric disease and treatment2016

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

Open access · goldAbstract read
In one paragraph

Article in Neuropsychiatric disease and treatment, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
2.9field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 11 citations in OpenAlex.

  1. Review
  2. Opioid Prescribing in the Elderly: A Systematic Review.The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 2020
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Emiliano PetròRehabiliation and Alzheimer Unit, San Pietro Polyclinic, Ponte San Pietro, Italy.
Elena RuffiniRehabiliation and Alzheimer Unit, San Pietro Polyclinic, Ponte San Pietro, Italy.
Melania CappuccioAlzheimer Center, P. Gusmini Foundation, Vertova, Italy.
Valeria GueriniAlzheimer Center, P. Gusmini Foundation, Vertova, Italy.
Gloria BelottiSanta Maria Ausiliatrice Foundation, Bergamo, Italy.
Sara FascendiniAlzheimer Center, Briolini Hospital FERB ONLUS, Gazzaniga, Italy.
Cristina LiciniAlzheimer Center, Briolini Hospital FERB ONLUS, Gazzaniga, Italy.
Claudio MarcassaCardiology, Maugeri Foundation IRCCS, Veruno, Italy.
Fondazione Europea Ricerca Biomedica · ITIstituti di Ricovero e Cura a Carattere Scientifico · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis 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.

methodsThis 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.

resultsThe 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.

conclusionIn 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.

Indexed as

Alzheimer’s diseasecognitive impairmentdementiaelderlyoxycodone/naloxone

Identifiers

PMID27042069
PMCPMC4780665
OpenAlexW2290000235

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.