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Oxycodone/Naloxone: role in chronic pain management, opioid-induced constipation, and abuse deterrence.

ABSTRACT: The use of opioids in the treatment of chronic pain is widespread; the prevalence of specific opioids varies from country to country and depends on product availability, national formulary systems, and provider preferences. Patients often receive opioids for legitimate treatment of pain conditions, but on the opposite side of the spectrum, nonmedical use of opioids is a significant public health concern. Opioids are associated with several side effects, and constipation is the most commonly reported and persistent symptom. Unlike some adverse effects associated with opioid use, tolerance does not develop to constipation. Opioid-induced constipation (OIC) is the most prevalent patient complaint associated with opioid use and has been associated with declines in various quality of life measures. OIC can be extremely difficult for patients to tolerate and may prompt patients to decrease or discontinue opioid treatment. Current management strategies for OIC are often insufficient. A prolonged-release formulation of oxycodone/naloxone (OXN) has been investigated for the treatment of nonmalignant and cancer pain and mitigation of OIC, and evidence is largely favorable. Studies have demonstrated the capability of OXN to alleviate OIC while maintaining pain control comparable to oxycodone-only regimens. There is insufficient evidence for OXN efficacy for patients with mild OIC or patients maintained on high doses of opioids, and use in these populations is controversial. The reduction of costs associated with OIC may provide overall cost effectiveness with OXN. Additionally, the presence of naloxone may deter abuse/misuse by those seeking to misuse the formulation by modes of administration other than oral ingestion. Most studies to date have occurred in European countries, and phase 3 trials continue in the United States. This review will include current therapeutic options for pain and constipation, unique characteristics of OXN, evidence related to use of OXN and its place in therapy, discussion of opioid abuse/misuse, and various abuse-deterrent mechanisms, and areas of continuing research.

SUBMITTER: DePriest AZ

PROVIDER: S-EPMC4108020 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:AimsTo assess whether naloxone prescribing in clinical contexts targeted pain patients most at risk for opioid overdose.DesignA retrospective cohort study using data from the Health Facts Database.SettingOver 600 United States healthcare facilities.ParticipantsThree patient groups were followed for 2 years during 2009 to 2017: individuals with shoulder or long bone fractures (n = 252 424), chronic pain syndrome (CPS) (n = 76 141), or non-traumatic low back pain (n = 792 956) who received an opioid prescription. Groups were chosen based on previous work.MeasurementsThe outcome was opioid overdose identified by International Classification of Diseases codes (ICDs) and the primary predictor was number of naloxone prescriptions identified by National Drug Codes (NDCs).FindingsOpioid overdoses occurred among 0.16% of fracture patients (average follow-up time to overdose [AFU] = 240 days), 1.28% of CPS patients (AFU = 244 days), and 0.30% low back pain patients (AFU = 264 days). A total of 58 083 bone fracture patients received naloxone prescriptions, and naloxone prescription was associated with subsequent opioid overdose (hazard ratio [HR] = 1.87, 95% CI = 1.68-2.09), and number of subsequent overdoses (incidence rate ratio [IRR] = 1.89, 95% CI = 1.69-2.12). A total of 19 529 CPS patients received naloxone prescriptions, and naloxone prescription was associated with subsequent opioid overdose (HR = 1.69, 95% CI = 1.61-1.78) and number of subsequent overdoses (IRR = 1.74, 95% CI = 1.67-1.83). A total of 110 608 low back pain patients received naloxone prescriptions, and naloxone prescription was associated with subsequent opioid overdose (HR = 1.33, 95% CI = 1.27-1.40) and number of subsequent overdoses (IRR = 1.35, 95% CI = 1.29-1.41).ConclusionsReceiving a naloxone prescription appears to be associated with increased risk of subsequent opioid overdose among patients with acute and chronic pain, suggesting prescribers often identify patients most in need of naloxone.

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Oxycodone/Naloxone: role in chronic pain management, opioid-induced constipation, and abuse deterrence.

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