Prolonged-release oxycodone/naloxone in opioid-naïve patients – subgroup analysis of a prospective observational study

Abstract

Objective: Prolonged-release oxycodone/naloxone (OXN PR) showed improved gastrointestinal tolerability and equivalent analgesic efficacy compared to oxycodone alone in patients with non-cancer pain or cancer pain. This is the first dataset to demonstrate its effectiveness and safety compared to other strong opioids in opioid-naïve patients.

Methods: This is a subgroup analysis of a 4- to 6-week multicenter, observational study. A total of 162 opioid-naïve patients with moderate-to-severe pain of varying etiologies received either OXN PR or other strong opioids (control group). Documented parameters include pain relief (numeric rating scale), bowel function (Bowel Function Index [BFI]), pain-related functional impairment (Brief Pain Inventory Short Form), quality of life (QoL; EuroQol EQ-5D-3L) and a global therapy assessment.

Results: OXN group patients experienced a substantial clinically important reduction in mean pain intensity of 51.4%, compared to a 28.6% reduction in control patients. Although the BFI remained in the reference range in both groups, there was a difference between BFI changes during treatment in favor of OXN PR. The superior effectiveness of OXN PR was paralleled by greater improvements of pain interference and QoL and fewer adverse drug reactions compared to other strong opioids.

Conclusion: The favorable outcomes under real-life conditions suggest that OXN PR provides a valuable option for treatment of moderate-to-severe pain without using weak opioids first.

Keywords:

• naloxone
• opioid
• opioid-induced bowel dysfunction
• oxycodone
• pain
• quality of life

Acknowledgments

The authors are indebted to the physicians who documented the patients in this trial. Copyright for the Bowel Function Index is owned by Mundipharma Laboratories GmbH, Switzerland, 2002; the BFI is also the subject of European Patent Application Publication No. EP 1,860,988 and corresponding patents and applications in other countries. The study is registered with the German Federal Institute for Drugs and Medical Devices (BfArM) under study code OXN9505.

Declaration of interest

The study was supported by Mundipharma GmbH, Limburg, Germany, who designed the study with support from IZKS, Johannes-Gutenberg-University Mainz, Germany, and provided funding for data analysis and medical writing support. S Hesselbarth declares receiving payments for lectures from Mundipharma, Grünenthal, Pharm Allergan, Pfizer and Teva. K Hermanns has received payments for lectures from Mundipharma, Janssen-Cilag, Pfizer and AWD/Teva. P Oepen is an employee of Mundipharma. Medical writing assistance and editorial support was funded by Mundipharma and was carried out by J Walstab, Physicians World Europe GmbH, Mannheim, Germany. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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