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Randomized Controlled Trial
. 2010 May;64(6):763-74.
doi: 10.1111/j.1742-1241.2010.02360.x. Epub 2010 Mar 29.

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

A Sandner-Kiesling  1 , P Leyendecker, M Hopp, L Tarau, J Lejcko, W Meissner, P Sevcik, M Hakl, R Hrib, R Uhl, H Dürr, K Reimer
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Free PMC article
Randomized Controlled Trial

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

A Sandner-Kiesling et al. Int J Clin Pract. 2010 May.
Free PMC article

Abstract

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.

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Figures

Figure 1
Figure 1
Study design of (A) the analgesia study and (B) the bowel function study. OXN, oxycodone PR/naloxone PR; OXY, oxycodone PR; OXYIR, oxycodone immediate-release; R, randomisation
Figure 2
Figure 2
Patient disposition in (A) the analgesia study and (B) the bowel function study
Figure 3
Figure 3
Brief Pain Inventory-Short Form item ‘average pain over the last 24 h’– mean score by visit: analgesia study (n = 379). BPI-SF, Brief Pain Inventory – Short Form
Figure 4
Figure 4
Mean BFI by visit: bowel function study for the LOCF full extension population (n = 258) and score according to double-blind phase treatment. BFI, Bowel Function Index; LOCF, last observation carried forward; PR, prolonged-release
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References

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