Clinical trial registry number: 2005-002398-57 and 2004-003752-19 (Eudra-CT).
Long-term efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of non-cancer chronic pain
Version of Record online: 29 MAR 2010
© 2010 Blackwell Publishing Ltd
International Journal of Clinical Practice
Volume 64, Issue 6, pages 763–774, May 2010
How to Cite
Sandner-Kiesling, A., Leyendecker, P., Hopp, M., Tarau, L., Lejcko, J., Meissner, W., Sevcik, P., Hakl, M., Hrib, R., Uhl, R., Dürr, H. and Reimer, K. (2010), Long-term efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of non-cancer chronic pain. International Journal of Clinical Practice, 64: 763–774. doi: 10.1111/j.1742-1241.2010.02360.x
Disclosures P. Leyendecker, M. Hopp, R. Uhl, H. Dürr and K. Reimer are employed by Mundipharma Research GmbH & Co. KG at the time of study conduct and article drafting. W. Meissner was involved as scientific advisor to this study and during the development and drafting of this article. A. Sander-Kiesling, L. Tarau, P. Sevcik, M. Hakl and R. Hrib, were involved as investigators in the clinical studies reported here. There is no financial interest linked to the preparation and authorship of the article.
Re-use of this article is permitted in accordance with the Terms and Conditions set out at http://www3.interscience.wiley.com/authorresources/onlineopen.html
- Issue online: 9 APR 2010
- Version of Record online: 29 MAR 2010
- Paper received December 2009, accepted January 2010
Objective: The aim of this study was to assess safety and efficacy of fixed combination oxycodone prolonged release (PR)/naloxone PR in terms of both analgesia and improving opioid-induced bowel dysfunction (OIBD) and associated symptoms, such as opioid-induced constipation (OIC), in adults with chronic non-cancer pain.
Study design: These were open-label extension studies in which patients who had previously completed a 12-week, double-blind study received oxycodone PR/naloxone PR for up to 52 weeks. The analgesia study assessed pain using the modified Brief Pain Inventory-Short Form (BPI-SF). The bowel function study assessed improvements in constipation using the Bowel Function Index (BFI).
Results: At open-label baseline in the analgesia study (n = 379), mean score [± standard deviation (SD)] for the BPI-SF item ‘average pain over the last 24 h’ was 3.9 ± 1.52, and this remained low at 6 months (3.7 ± 1.59) and 12 months (3.8 ± 1.72). Mean scores for BPI-SF item ‘sleep interference’, and the BPI-SF ‘pain’ and ‘interference with activities’ subscales also remained low throughout the 52-week study. In the bowel function study (n = 258), mean BFI score (± SD) decreased from 35.6 ± 27.74 at the start of the extension study to 20.6 ± 24.01 after 12 months of treatment with oxycodone PR/naloxone PR. Pain scores also remained low and stable during this study. Adverse events in both extension phases were consistent with those associated with opioid therapy; no additional safety concerns were observed.
Conclusion: Results from these two open-label extension studies demonstrate the long-term efficacy and tolerability of fixed combination oxycodone PR/naloxone PR in the treatment of chronic pain. Patients experienced clinically relevant improvements in OIBD while receiving effective analgesic therapy.