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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

Authors Lazzari M, Marcassa C, Natoli S, Carpenedo R, Caldarulo C, Silvi M, Dauri M

Received 4 February 2016

Accepted for publication 10 March 2016

Published 13 May 2016 Volume 2016:11 Pages 641—649

DOI https://doi.org/10.2147/CIA.S105821

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Supriya Swarnkar

Peer reviewer comments 4

Editor who approved publication: Dr Richard Walker


Marzia Lazzari,1 Claudio Marcassa,2 Silvia Natoli,1 Roberta Carpenedo,1 Clarissa Caldarulo,1 Maria B Silvi,1 Mario Dauri1

1Department of Emergency and Critical Care Medicine, Pain Medicine and Anaesthesiology, Tor Vergata Polyclinic, University of Rome, Rome, 2Cardiology Division, Fondazione Maugeri IRCCS Veruno, Novara, Italy

Purpose: Chronic pain has a high prevalence in the aging population. Strong opioids also should be considered in older people for the treatment of moderate to severe pain or for pain that impairs functioning and the quality of life. This study aimed to assess the efficacy and safety of the direct switch to low-dose strong opioids (World Health Organization-Step III drugs) in elderly, opioid-naive patients.
Patients and methods: This was a single-center, retrospective, observational study in opioid-naive patients aged ≥75 years, with moderate to severe chronic pain (>6-month duration) and constipation, who initiated treatment with prolonged-release oxycodone/naloxone (OXN-PR). Patients were re-evaluated after 15, 30, and 60 days (T60, final observation). Response to treatment was defined as an improvement in pain of ≥30% after 30 days of therapy without worsening of constipation.
Results: One-hundred and eighty-six patients (mean ± SD age 80.7±4.7 years; 64.5% women) with severe chronic pain (mean average pain intensity 7.1±1.0 on the 11-point numerical rating scale) and constipation (mean Bowel Function Index 64.1±24.4; 89.2% of patients on laxatives) were initiated treatment with OXN-PR (mean daily dose 11.3±3.5 mg). OXN-PR reduced pain intensity rapidly and was well tolerated; 63.4% of patients responded to treatment with OXN-PR. At T60 (mean daily OXN-PR dose, 21.5±9.7 mg), the pain intensity was reduced by 66.7%. In addition, bowel function improved (mean decrease of Bowel Function Index from baseline to T60, -28.2, P<0.0001) and the use of laxatives decreased. Already after 15 days and throughout treatment, ~70% of patients perceived their status as much/extremely improved. Only 1.6% of patients discontinued treatment due to adverse events.
Conclusion: Low-dose OXN-PR in elderly patients naive to opioids proved to be an effective option for the treatment of moderate to severe chronic pain. Large-scale trials are needed to improve clinical guidance in the assessment and treatment of pain in older people.

Keywords: chronic pain, elderly, naloxone, opioid, oxycodone

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