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Efficacy and safety of oxycodone/naloxone as add‐on therapy to gabapentin or pregabalin for the management of chemotherapy‐induced peripheral neuropathy in Korea
Aims To investigate the efficacy and safety of oxycodone/naloxone in patients with chemotherapy‐induced peripheral neuropathy (CIPN) inadequately controlled with pregabalin or gabapentin. Methods This 4‐week, multicenter, interventional, single‐arm phase IV study included 72 Korean patients with CIP...
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Published in: | Asia-Pacific journal of clinical oncology 2018-10, Vol.14 (5), p.e448-e454 |
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Main Authors: | , , , , , , , |
Format: | Article |
Language: | English |
Subjects: | |
Citations: | Items that this one cites Items that cite this one |
Online Access: | Get full text |
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Summary: | Aims
To investigate the efficacy and safety of oxycodone/naloxone in patients with chemotherapy‐induced peripheral neuropathy (CIPN) inadequately controlled with pregabalin or gabapentin.
Methods
This 4‐week, multicenter, interventional, single‐arm phase IV study included 72 Korean patients with CIPN inadequately controlled with pregabalin or gabapentin (Numeric Rating Scale 0–10; NRS ≥4 at baseline). In addition to pregabalin or gabapentin at existing doses, patients received 20/10 mg/day oxycodone/naloxone (up‐titrated to 80/40 mg/day as needed). The primary endpoint was change in NRS score after 4 weeks. Secondary endpoints included Functional Assessment of Cancer Therapy/Gynecologic Oncology Group‐Neurotoxicity (FACT/GOG‐NTX) scores and safety assessments.
Results
The mean ± standard deviation (SD) dose of oxycodone/naloxone was 23.3 ± 7.5 mg/day. At week 4, NRS score reduction was 1.29 ± 1.84 points (21.4% reduction; P |
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ISSN: | 1743-7555 1743-7563 |
DOI: | 10.1111/ajco.12822 |