Long term efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of non-cancer pain

• Authors: SANDER-KIESILING A.; LEYENDECKER P.; HOPP M.; TARAU L.; LEJCKO J.; ŠEVČÍK Pavel; HAKL Marek; HŘIB Radovan; UHL R.; DUERR H.; REIMER K.; MEISSNER W.
• Year of publication: 2010
• Type: Article in Periodical
• Magazine / Source: International Journal of Clinical Practice
• MU Faculty or unit: Faculty of Medicine
• Doi: http://dx.doi.org/10.1111/j.1742-1241.2010.02360.x
• Field: Pharmacology and pharmaceutical chemistry
• Keywords: RANDOMIZED CONTROLLED-TRIAL; OPIOID-INDUCED CONSTIPATION; DIABETIC-NEUROPATHY; BOWEL DYSFUNCTION; CANCER PAIN; COMBINATION; MODERATE; PREVALENCE
• Description: 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.