Prolonged release oxycodone and naloxone treatment counteracts opioid-induced constipation in patients with severe pain compared to previous analgesic treatment

Abstract

Objective: Treatment with prolonged-release oxycodone/naloxone (PR OXN) has been shown to improve opioid induced constipation (OIC) in constipated patients. This publication reports on a real-life observational study investigating the efficacy of PR OXN with regard to bowel function in patients switching to PR OXN from WHO step 1, step 2 and step 3 opioids.

Methods: Patients with chronic pain experiencing insufficient pain relief and/or unacceptable side effects were switched to PR OXN and monitored in this observational study with respect to efficacy regarding bowel function and efficacy regarding pain relief in comparison with previous analgesic therapy. A patient was considered a responder with respect to efficacy if this assessment was “slightly better”, “better” or “much better” compared with previous therapy. Bowel function index, pain intensity, quality of life, laxative medication use, and safety analgesic were also evaluated.

Results: A total of 1338 patients (mean [SD] age 64.3 [14.9], 63% female) were observed for 43 [3–166] days (median [range]) during treatment with PR OXN. Overall response rate regarding bowel function efficacy was 82.5%. Patients with symptoms of constipation at study entry obtained a clinically relevant improvement of the bowel function index (BFI) within the first 2 weeks of PR OXN treatment. Non-constipated patients at study entry maintained normal bowel function despite switching to treatment with the opioid PR OXN.

Conclusion: In conclusion, treatment with PR OXN results in a significant and clinically relevant improvement of bowel function. During the observation of the treatment with PR OXN patients reported an improvement of quality of life (QoL). More interestingly, non-constipated patients maintained a normal bowel function, showing prevention of constipation despite the use of an opioid.

Keywords:

• Chronic pain
• oxycodone/naloxone
• opioid-induced constipation
• quality of life
• malignant pain
• non-malignant pain

Transparency

Declaration of funding

This study was designed by Mundipharma Pharmaceuticals BV and Mundipharma Comm VA, and conducted by qualified investigators under the sponsorship of Mundipharma Pharmaceuticals BV and Mundipharma Comm. VA. Data was gathered by the sponsor and evaluated jointly by the authors and the sponsor.

Author contributions: F.H. and I.M. provided scientific advice to Mundipharma Pharmaceuticals BV. H.P. participated as investigator in the study. All authors were involved in the development, writing, critical reviewing and approval of this manuscript.

Declaration of financial/other relationships

I.M., H.P. and F.H. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article. Y.v.M. and G.K.-K. have disclosed that they have personal fees from Mundipharma Pharmaceuticals BV during the conduct of the study and personal fees from Mundipharma Pharmaceuticals BV, outside the submitted work. J.V.O.d.B. has disclosed that he has received personal fees from Mundipharma Comm VA at the time of study conduct and article drafting and personal fees from Mundipharma Comm VA outside the submitted work.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgements

The authors would like to thank T. Mudde, Clinquest Services BV, for providing statistical analysis services and advice. The corresponding author takes responsibility for the integrity and the accuracy of the data analysis, and had final responsibility for the decision to submit for publication. The authors would also like to thank all physicians and their patients who have participated in the study.