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Clinical Trial
. 2015 Mar;23(3):823-30.
doi: 10.1007/s00520-014-2435-5. Epub 2014 Sep 14.

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

Sam H Ahmedzai  1 , Wojciech Leppert, Marcin Janecki, Artur Pakosz, Mark Lomax, Heike Duerr, Michael Hopp
Affiliations
Clinical Trial

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

Sam H Ahmedzai et al. Support Care Cancer. 2015 Mar.

Abstract

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.

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Figures

Fig 1
Fig 1
Study design (A) and patient disposition (B). AEs adverse events, n number of patients; OLE open-label extension, OXN PR prolonged-release oxycodone/naloxone tablets, OxyPR prolonged-release oxycodone tablets, R randomization, V visit, WK week. Superscript letter a indicates day or week since the beginning of the open-label extension phase; V9a was the first visit of the open-label extension phase and typically occurred on the same day as visit 9 (end of double-blind phase). Superscript letter b includes two patients who discontinued from the double-blind phase due to constipation and entered the OLE phase
Fig 2
Fig 2
BPI-SF average pain scores (LOCF) by study visit (OLE safety population). BPI-SF Brief Pain Inventory-Short Form, LOCF last observation carried forward, OLE open-label extension, OXN PR prolonged-release oxycodone/naloxone tablets, OxyPR prolonged-release oxycodone tablets, SD standard deviation. Superscript letter a indicates day or week since the beginning of the open-label extension phase. Data for the DB period are based on the per protocol population (LOCF): OXN PR, n = 62 OxyPR, n = 71; higher scores indicate more severe pain (0 no pain, 10 most severe pain)
Fig 3
Fig 3
BFI scores (LOCF) by study visit (OLE safety population). BFI bowel function index, LOCF last observation carried forward, OLE open-label extension, OXN PR prolonged-release oxycodone/naloxone tablets, OxyPR prolonged-release oxycodone tablets, SD standard deviation. Superscript letter a indicates day or week since the beginning of the open-label extension phase. Data for the DB period are based on the full analysis population (LOCF); OXN PR, n = 77; OxyPR, n = 80; higher scores indicate more severe constipation
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