Observational studyClinical interventions in aging2015
Efficacy and tolerability of low-dose oral prolonged-release oxycodone/naloxone for chronic nononcological pain in older patients.
Observational study in Clinical interventions in aging, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
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Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.
- The effect of naloxone treatment on opioid-induced side effects: A meta-analysis of randomized and controlled trails.Medicine · 2016Pooled it
- Article
- Efficacy of duloxetine compared with opioid for postoperative pain control following total knee arthroplasty.PloS one · 2021Article
- Cognitive Function During Opioid Tapering in Patients with Chronic Pain: A Prospective Cohort Study.Journal of pain research · 2020Article
- Linking Persistent Pain and Frailty in Older Adults.Pain medicine (Malden, Mass.) · 2020Article
- Guidance on opioids prescribing for the management of persistent non-cancer pain in older adults.World journal of clinical cases · 2017Review
- Switching to low-dose oral prolonged-release oxycodone/naloxone from WHO-Step I drugs in elderly patients with chronic pain at high risk of early opioid discontinuation.Clinical interventions in aging · 2016Observational
- Long-term efficacy and safety of oxycodone-naloxone prolonged release in geriatric patients with moderate-to-severe chronic noncancer pain: a 52-week open-label extension phase study.Drug design, development and therapy · 2016Observational
- Low-dose oral prolonged-release oxycodone/naloxone for chronic pain in elderly patients with cognitive impairment: an efficacy-tolerability pilot study.Neuropsychiatric disease and treatment · 2016Article
- Developments in managing severe chronic pain: role of oxycodone-naloxone extended release.Drug design, development and therapy · 2015Review
- Is oxycodone/naloxone effective and safe in managing chronic pain of a fragile elderly patient with multiple skin ulcers of the lower limbs? A case report.Clinical interventions in aging · 2015Article
Corrections and comments
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Authors and funding
5 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeChronic 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.
methodsThis 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.
resultsOf 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.
conclusionFindings 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.
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