Analgesic Efficacy and Safety of Oxycodone in Combination With Naloxone as Prolonged Release Tablets in Patients With Moderate to Severe Chronic Pain |
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| Affiliation: | 2. Mundipharma Research GmbH & Co. KG, Limburg (Lahn), Germany;3. Klinik für Anaesthesiologie und Intensivmedizin, Universitätsklinikum Jena, Jena, Germany;4. Diagnostic Units Hungary, Budapest, Hungary;6. Praxis für Schmerztherapie, Berlin, Germany;5. University Witten/Herdecke, Witten, Germany;1. Laboratory of Neuromodulation, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts;2. Department of Biomedical Engineering, The City College of the City University of New York, New York, New York;3. Postgraduate Program in Interactive Processes of Organs and Systems, Federal University of Bahia, Salvador, Bahia, Brazil;4. Soterix Medical, Inc, New York, New York;5. ElMindA Ltd, Herzliya, Israel;7. Ben Gurion University, Beersheba, Israel;1. Department of Physical Therapy, University of Florida, Gainesville, Florida;2. Brooks Rehabilitation–College of Public Health and Health Professions (University of Florida) Research Collaboration, University of Florida, Gainesville, Florida;3. Arthritis Research UK Primary Care Centre, Research Institute of Primary Care and Health Sciences, Keele University, Staffordshire, United Kingdom;1. Department of Neuroscience & Padova Neuroscience Center, University of Padova, Padova Italy;2. IRCCS Istituto delle Scienze Neurologiche di Bologna, Programma Neuroimmagini Funzionali e Molecolari, Bologna, Italy;3. Cognitive Neuroscience Research Group, IRCCS San Camillo Hospital, Venice, Italy;4. Department of Neuroscience, University of Sheffield, Sheffield, UK;5. Research Center for Motor Control and Neuroplasticity, KU Leuven, Leuven, Belgium;6. Brain Imaging and Neural Dynamics Research Group, IRCCS San Camillo Hospital, Venice, Italy;1. Centre for Applied Psychology, Faculty of Health, University of Canberra, Canberra, Australian Capital Territory, Australia;3. Discipline of Physiotherapy, Faculty of Health, University of Canberra, Canberra, Australian Capital Territory, Australia;2. University of Canberra Research Institute for Sport and Exercise, University of Canberra, Canberra, Australian Capital Territory, Australia |
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| Abstract: | This randomized, double-blind, placebo- and active-controlled, parallel-group study was designed to demonstrate the superiority of oxycodone in combination with naloxone in a prolonged release (PR) formulation over placebo with respect to analgesic efficacy. The active control group was included for sensitivity and safety analyses, and furthermore to compare the analgesic efficacy and bowel function of oxycodone PR/naloxone PR with oxycodone PR alone. The analgesic efficacy was measured as the time from the initial dose of study medication to multiple pain events (ie, inadequate analgesia) in patients with moderate to severe chronic low back pain. The full analysis population consisted of 463 patients. The times to recurrent pain events were significantly longer in the oxycodone PR/naloxone PR group compared with placebo (P < .0001–.0003); oxycodone PR/naloxone PR reduced the risk of pain events by 42% (P < .0001; full analysis population). The appearance of pain events was comparable for oxycodone PR/naloxone PR versus oxycodone PR, confirming that the addition of naloxone PR to oxycodone PR in a combination tablet did not negatively affect analgesic efficacy of the opioid. Furthermore, oxycodone PR/naloxone PR offers benefits in terms of an improvement in bowel function. In a therapeutic area of great unmet need, therefore, the combination tablet of oxycodone PR/naloxone PR offers patients effective analgesia while improving opioid-induced bowel dysfunction. Taken together with the observation that the safety profile of oxycodone PR/naloxone PR is consistent with that expected from other opioid analgesics except opioid-induced constipation, these findings indicate that the addition of naloxone to oxycodone in a PR combination tablet offers improved tolerability. Oxycodone PR/naloxone PR is therefore a promising new treatment approach for the management of chronic pain.PerspectiveThis study evaluated the analgesic efficacy and safety of the combination of oxycodone PR/naloxone PR in chronic nonmalignant pain. Opioids are often reduced in dosage or even discontinued as a result of impaired bowel function, leading to insufficient pain treatment. Not only does oxycodone PR/naloxone PR demonstrate analgesic efficacy comparable with oxycodone PR, but it also improves opioid-induced bowel dysfunction, and may therefore improve the acceptability of long-term opioid treatment for chronic pain. |
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