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.
Highlights
Almost one in five adults within the European Union suffers from chronic pain [1], imposing a significant burden on their quality of life (QoL)
The primary disadvantage associated with these agents is the development of opioid-induced bowel dysfunction (OIBD) in many patients, which commonly manifests as significant constipation [10]
Bowel function study The objective of this study was to assess whether patients with moderate-to-severe non-cancer pain taking oxycodone prolonged release (PR) ⁄ naloxone PR had improvements in bowel function, as measured by the validated Bowel Function Index (BFI) [30, 32] at each study visit over 52 weeks
Summary
Almost one in five adults within the European Union suffers from chronic pain [1], imposing a significant burden on their quality of life (QoL). Persistent chronic pain is associated with depression and anxiety, interference with work and personal relationships and loss of independence [2]. Oxycodone is a semi-synthetic, opioid analgesic that has demonstrated effectiveness in treating cancer and non-cancer related pain [4,5,6,7,8,9]. The primary disadvantage associated with these agents is the development of opioid-induced bowel dysfunction (OIBD) in many patients, which commonly manifests as significant constipation [10]. Constipation is the most frequently-reported adverse event in patients receiving opioid treatment
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have