Patient preference with respect to QoL and reduction in opioid-induced constipation (OIC) after treatment with prolonged-release (PR) oxycodone/naloxone compared with previous analgesic therapy [PREFER study]

Summary Objective The aim of this study was to assess patient preference in terms of quality of life (QoL), analgesia and bowel function for patients with moderate to severe chronic non‐malignant pain, when treated with oxycodone PR/naloxone PR compared with the previous WHO‐step I and/or WHO‐step II analgesic treatment . Study design This was a 3‐week open‐label phase 3b study conducted in Belgium and the Netherlands, after 3 weeks patients could enter an extension phase. Patient preference with respect to QoL for oxycodone PR/naloxone PR treatment compared with previous WHO‐step I and/or WHO‐step II analgesics was assessed. A patient was considered a responder with respect to QoL if this assessment was ‘better’ or ‘much better’ compared with previous WHO‐step I or II analgesics at any time point. Results Response rate with respect to QoL was 59.2% (95% CI: 51.7–66.8%) for the Full Analysis (FA)‐population, for the Per Protocol‐population response rate was 71.7% (95% CI: 63.1–80.3%). Explorative analysis showed that response rate with respect to QoL was highest in constipated patients pretreated with WHO‐step II analgesics (73.8%). Mean ± SD pain score in the FA‐population at start was 74.7 ± 16.6 decreasing to 53.9 ± 24.3 after a median (range) treatment period of 173.5 (31–771) days. For constipated subjects the significant reduction in constipation [improvement of the Bowel Function Index (BFI)], was −24.8 points (95% CI: −17.1 to −32.5). BFI for non‐constipated subjects remained well below 28.8. Adverse events with oxycodone PR/naloxone PR treatment were well‐known opioid‐related adverse events. Conclusion This study shows that the studied patients previously treated with WHO‐step I and/or WHO‐step II analgesics prefer treatment with oxycodone PR/naloxone PR with respect to QoL. Moreover, the study shows that treatment with oxycodone PR/naloxone PR significantly reduces OIC in constipated patients and that non‐constipated patients do not develop OIC during treatment with oxycodone PR/naloxone PR.