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Cancer pain therapy with a fixed combination of prolonged-release oxycodone/naloxone: results from a non-interventional study

Authors Nolte T, Schutter U, Loewenstein O

Received 12 June 2013

Accepted for publication 17 September 2013

Published 19 December 2013 Volume 2014:5 Pages 1—13

DOI https://doi.org/10.2147/POR.S49793

Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 2


Thomas Nolte,1 Ulf Schutter,2 Oliver Loewenstein3

1Pain and Palliative Care Centre Wiesbaden, Wiesbaden, Germany; 2Clinical Office for Pain Therapy, Marienhospital Marl, Marl, Germany; 3Regional Pain and Palliative Care Centre, Mainz, Germany

Background: Strong opioids, including oxycodone, are the most effective analgesics used to combat moderate to severe cancer pain, but opioid-induced bowel dysfunction is a relevant problem associated with the therapy. Clinical studies have demonstrated equivalent analgesic efficacy and improved bowel function in treatment with a fixed combination of prolonged-release (PR) oxycodone and PR naloxone compared to oxycodone alone in patients with nonmalignant pain. Here, we report of a prospective, non-interventional study evaluating the effectiveness and safety of PR oxycodone/PR naloxone in a subgroup of patients with severe cancer pain.
Patients and methods: Within the non-interventional multicenter study, 1,178 cancer patients with severe chronic pain received PR oxycodone/PR naloxone, dosed according to pain intensity, for 4 weeks. Recorded variables included pain intensity, patient-reported bowel function (Bowel Function Index), and pain-related functional impairment as a measure of quality of life (QoL).
Results: During treatment with PR oxycodone/PR naloxone, clinically relevant improvements in pain intensity were observed in opioid-naïve patients and in patients pretreated with weak or strong opioids, as reflected by reductions in pain scores of 51%, 53%, and 33%, respectively. Improvement in analgesia was paralleled by a significant reduction of opioid-induced bowel dysfunction in opioid-pretreated patients. The reductions in the mean Bowel Function Index of −20.5 and −36.5 in patients pretreated with weak and strong opioids, respectively, represent clinically relevant improvements in bowel function. Pain-related functional impairment decreased consistently across all seven domains, which is equivalent to a substantial improvement in QoL.
Conclusion: This subgroup analysis of cancer patients within a large non-interventional study demonstrates that treatment with PR oxycodone/PR naloxone provides effective analgesia with minimization of bowel dysfunction and improved QoL. These data extend our knowledge of the effectiveness and tolerability of PR oxycodone/PR naloxone to the population of patients with cancer under real-life conditions.

Keywords: neoplasms, pain, oxycodone, naloxone, constipation, quality of life

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