Observational studyDrug design, development and therapy2016
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.
Observational study in Drug design, development and therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed, 24 citations in OpenAlex.
- Efficacy of Acupuncture for Pain in Parkinson's Disease: Study Protocol for a Randomized Controlled Trial.Journal of pain research · 2026Article
- Insights into the Current and Possible Future Use of Opioid Antagonists in Relation to Opioid-Induced Constipation and Dysbiosis.Molecules (Basel, Switzerland) · 2023Review
- ENhANCE trial protocol: A multi-centre, randomised, phase IV trial comparing the efficacy of oxycodone/naloxone prolonged release (OXN PR) versus oxycodone prolonged release (Oxy PR) tablets in patients with advanced cancer.Contemporary clinical trials communications · 2022Article
- The effect of opioids on the cognitive function of older adults: results from the Personality and Total Health through life study.Age and ageing · 2021Article
- Efficacy and tolerability of tapentadol for the treatment of chronic low back pain in elderly patients.Aging clinical and experimental research · 2021Article
- Opioid Prescribing in the Elderly: A Systematic Review.The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 2020Review
- Cognitive Function During Opioid Tapering in Patients with Chronic Pain: A Prospective Cohort Study.Journal of pain research · 2020Article
- Update on treatments for nonmotor symptoms of Parkinson's disease-an evidence-based medicine review.Movement disorders : official journal of the Movement Disorder Society · 2019Review
- Guidance on opioids prescribing for the management of persistent non-cancer pain in older adults.World journal of clinical cases · 2017Review
- New opioid prescribing guidelines released in the US: what impact will they have in the care of older patients with persistent pain?Current medical research and opinion · 2017Article
Corrections and comments
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTwo-thirds of older people suffer from chronic pain and finding valid treatment options is essential. In this 1-yearlong investigation, we evaluated the efficacy and safety of prolonged-release oxycodone-naloxone (OXN-PR) in patients aged ≥70 (mean 81.7) years.
methodsIn this open-label prospective study, patients with moderate-to-severe noncancer chronic pain were prescribed OXN-PR for 1 year. The primary endpoint was the proportion of patients who achieved ≥30% reduction in pain intensity after 52 weeks of treatment, without worsening bowel function. The scheduled visits were at baseline (T0), after 4 weeks (T4), and after 52 weeks (T52).
resultsFifty patients completed the study. The primary endpoint was achieved in 78% of patients at T4 and 96% at T52 (P<0.0001). Pain intensity, measured on a 0-10 numerical rating scale, decreased from 6.0 at T0 to 2.8 at T4 and to 1.7 at T52 (P<0.0001). Mean daily dose of oxycodone increased from 10 to 14.4 mg (T4) and finally to 17.4 mg (T52). Bowel Function Index from 35.1 to 28.7 at T52. No changes were observed in cognitive functions (Mini-Mental State Examination evaluation), while daily functioning improved (Barthel Index from 53.1 to 61.0, P<0.0001). The Screener and Opioid Assessment for Patients with Pain-Revised score at 52 weeks was 2.6 (standard deviation 1.6), indicating a low risk of aberrant medication-related behavior. In general, OXN-PR was well tolerated.
conclusionThis study of the long-term treatment of chronic pain in a geriatric population with OXN-PR shows satisfying analgesic effects achieved with a stable low daily dose, coupled with a good safety profile and, in particular, with a reduction of constipation, often present during opioid therapy. Our findings support the indications of the American Geriatrics Society, suggesting the use of opioids to treat pain in older people not responsive to acetaminophen or nonsteroidal anti-inflammatory drugs.
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