Long-term safety and efficacy of oxycodone/naloxone prolonged-release tablets in patients with moderate-to-severe chronic cancer pain

• Published in: Supportive care in cancer Vol. 23; no. 3; pp. 823 - 830
• Main Authors: Ahmedzai, Sam H., Leppert, Wojciech, Janecki, Marcin, Pakosz, Artur, Lomax, Mark, Duerr, Heike, Hopp, Michael
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.03.2015; Springer; Springer Nature B.V
• Subjects: Aged; Analgesics, Opioid - administration & dosage; Analgesics, Opioid - adverse effects; Cancer; Cancer pain; Care and treatment; Chronic Pain - drug therapy; Chronic Pain - etiology; Constipation; Constipation - chemically induced; Delayed-Action Preparations - administration & dosage; Delayed-Action Preparations - adverse effects; Double-Blind Method; Drug Combinations; Effectiveness; Female; Follow-Up Studies; Humans; Male; Medicine; Medicine & Public Health; Middle Aged; Naloxone - administration & dosage; Naloxone - adverse effects; Narcotics; Neoplasms - complications; Nursing; Nursing Research; Oncology; Original; Original Article; Oxycodone - administration & dosage; Oxycodone - adverse effects; Pain management; Pain Management - methods; Pain Measurement; Pain Medicine; Patient safety; Quality of Life; Rehabilitation Medicine; Severity of Illness Index; Tablets; Treatment Outcome; Opioid-induced constipation; Analgesia; Bowel function; Naloxone; Oxycodone
• ISSN: 0941-4355; 1433-7339
• DOI: 10.1007/s00520-014-2435-5

Aim To evaluate the long-term safety and efficacy of prolonged-release oxycodone/naloxone (OXN PR) and its impact on quality of life (QoL), in patients with moderate-to-severe cancer pain. Methods This was an open-label extension (OLE) of a 4 week, randomized, double-blind (DB) study in which patients with moderate-to-severe cancer pain had been randomized to OXN PR or oxycodone PR (OxyPR). During the OLE phase, patients were treated with OXN PR capsules (≤20/60 mg/day) for ≤24 weeks. Outcome measures included safety, efficacy and QoL. Results One hundred and twenty-eight patients entered the OLE, average pain scores based on the modified Brief Pain Inventory—Short Form were low and stable over the 24-week period. The improvement in bowel function and constipation symptoms as measured by the Bowel Function Index and patient assessment of constipation in patients treated with OXN PR during the 4-week DB study was maintained. In patients treated with OxyPR during the DB phase, bowel function and constipation symptoms were improved during the OLE. In the DB and in the OLE, health status and QoL were similar for patients treated with OXN PR and OxyPR. There were no unexpected safety or tolerability issues. Conclusions In patients with moderate-to-severe cancer pain, long-term use of OXN PR is well tolerated and effective, resulting in sustained analgesia, improved bowel function and improved symptoms of constipation.