Prolonged-release oxycodone/naloxone reduces opioid-induced constipation and improves quality of life in laxative-refractory patients: results of an observational study.

BACKGROUND: Opioids are an effective treatment for moderate-to-severe pain. However, they are associated with a number of gastrointestinal side effects, most commonly constipation. Laxatives do not target the underlying mechanism of opioid-induced constipation (OIC), so many patients do not have their symptoms resolved. Fixed-dose prolonged-release (PR) oxycodone/naloxone (OXN) tablets contain the opioid agonist oxycodone and the opioid antagonist naloxone. Nal-oxone blocks the action of oxycodone in the gut without compromising its analgesic effects. AIM: To evaluate the effectiveness of PR OXN in patients with severe pain who had laxative-refractory OIC with their previous opioid. METHODS: The study was carried out in 13 centers across the UK and Ireland, using a bespoke online tool to capture patients' data. Patients were reviewed according to normal clinical practice of each center and rated any changes in their constipation and quality of life (QoL) since starting PR OXN. Any change in patients' laxative use was also recorded. RESULTS: One hundred and seven patients were entered into the database, and 81 went on to attend at least one review. Of these, 54 (66.7%) reported an improvement in constipation and 50 (61.7%) reported an improvement in QoL since starting PR OXN. Fifty-seven patients (70.4%) said they had reduced laxative intake; 48 (59.3%) only needed laxatives as required. CONCLUSION: PR OXN reduced symptoms of constipation, improved QoL and reduced laxative intake in patients with OIC. It has a potential place early in any treatment strategy for severe pain in patients using opioids, particularly in patients who may be predisposed to constipation.

Oxycodone and Naloxone Combination: A 12-Week Follow-up in 20 Patients Shows Effective Analgesia Without Opioid-Induced Bowel Dysfunction.

INTRODUCTION: Opioid analgesics are widely regarded to be highly effective but are equally known for their side effects on the bowel. A new combination of the opioid analgesic oxycodone and naloxone has been developed to combat opioid-induced bowel dysfunction (OIBD) whilst still being effective as an analgesic. The aim of this observational study was to assess the analgesic efficacy of this new combination and to analyze its effect on bowel function. METHODS: Twenty-six patients underwent a trial of this new combination, with 21 patients reaching week 8 and 18 reaching week 12. RESULTS: A significant reduction was seen in the pain severity score at weeks 4, 8, and 12 (P < 0.05), and a significant improvement in the bowel function index was again seen at these points (P < 0.001 at week 4 and 12, P < 0.05 at week 8). In the patients' global impression of change, 83.3% of patients rated the new medication as an improvement compared to their previous regimen, and 87.5% rated it overall as "good" or "very good." CONCLUSION: This small single-center study suggests that the use of ONC in selected patients could lead to an improvement in pain severity and pain interference with a significant improvement in OIBD. Compliance with the combination is good, and it is generally well tolerated.