Prolonged-Release Oxycodone/Naloxone in Nonmalignant Pain: Single-Center Study in Patients with Constipation

Gatti, Antonio; Casali, Massimiliano; Lazzari, Marzia; Tufaro, Giuseppe; Gafforio, P.; Silvestri, Claudia; Marcassa, Claudio; Sabato, Alessandro

doi:10.1007/s12325-012-0074-0

Cited by 25 publications

(23 citation statements)

References 21 publications

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“…The new formulation of combined oral prolonged-release (PR) oxycodone/naloxone has demonstrated, both in randomized controlled trials and in post-marketing studies, full analgesic efficacy together with reduced OIC incidence, and a consequent decrease in the use of rescue medications and laxatives. 27 PR oxycodone/naloxone has potential advantages particularly for the elderly, and it is estimated to be a cost-effective analgesic option. 28 …”

Section: Discussionmentioning

confidence: 99%

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Opioid use for chronic pain management in Italy: results from the Orthopedic Instant Pain survey project

2014

Orthop Rev

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Pain is a common symptom in orthopedic patients, but is managed sub-optimally, partly due to scarce opioid use in severe cases. The aim of the Orthopedic Instant Pain Survey (POIS) was to evaluate changes in pain management in Italian orthopedic practice 2 years after a legislative change (Law 38/2010) simplifying opioid access for pain control. A web-based survey on the knowledge of this law and trends observed in clinical practice for severe pain treatment was administered to 143 Italian orthopedic specialists. In total, 101 (70%) respondents showed a high level of knowledge. Nevertheless, 54.5% stated that they do not use opioids for severe osteo-articular pain management. Main barriers to opioid use are fear of adverse events (61.4%), especially nausea/vomiting and constipation, and patient resistance (29.7%). A modest knowledge of pain classification was also demonstrated. Opioid use remains very limited in Italian orthopedic practice. Physicians’ fear of side effects showed poor knowledge of strategies for effective management of opioid-related adverse events, such as combined oral prolonged-release oxycodone/naloxone. Continuing educational programs could improve delivery of evidence-based pain management.

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Section: Discussionmentioning

confidence: 99%

“…In the orthopedic setting, our survey indicates a lack of knowledge of the new treatment options available today such as the co-administration of an opioid agonist with a µ-opioid receptor antagonist with negligible systemic availability, such as oral naloxone, to provide effective simplify and cost-effective analgesia. 27,28 …”

Section: Discussionmentioning

confidence: 99%

Opioid use for chronic pain management in Italy: results from the Orthopedic Instant Pain survey project

2014

Orthop Rev

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“…Despite this limitation, patient and provider preference for efficacy and tolerability indicate preference for OXN versus oxycodone PR [55]. Several observational studies have demonstrated successful use of OXN in clinical practice for a large number of patients, including geriatric populations [9, 60, 66–70]. …”

Section: Oxycodone/naloxone Sustained Release Formulationsmentioning

confidence: 99%

Oxycodone/Naloxone: Role in Chronic Pain Management, Opioid-Induced Constipation, and Abuse Deterrence

DePriest

Miller

2014

Pain Ther

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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.Electronic supplementary materialThe online version of this article (doi:10.1007/s40122-014-0026-2) contains supplementary material, which is available to authorized users.

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“…[34] in a retrospective, single center, observational study assessed the effectiveness and safety of OXN in consecutive patients with constipation and chronic non-malignant pain, both in opioid-naive and opioid-tolerant patients. Efficacy was assessed by pain intensity, bowel function, effective OXN dose, the Patient Global Impression of Change (PGIC) scale, rescue paracetamol, and laxative use.…”

Section: Oxycodone/naloxone Clinical Studiesmentioning

confidence: 99%

Reviews The place of oxycodone/naloxone in chronic pain management

Leppert¹

2013

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Opioid analgesics are usually effective in the management of severe chronic pain. However, symptoms of opioid-induced bowel dysfunction (OIBD) are common during opioid therapy. Opioid-induced bowel dysfunction is often unsuccessfully managed due to limited effectiveness and numerous adverse effects of traditional laxatives. Newer treatment possibilities directed at the pathomechanism of OIBD comprise combined prolonged-release oxycodone with prolonged-release naloxone (oxycodone/naloxone) tablets. Oxycodone/naloxone provides effective analgesia with limited impact on bowel function as oxycodone displays high oral bioavailability and naloxone act as local antagonist on opioid receptors in the gastrointestinal tract due to nearly complete inactivation in the liver. Oxycodone/naloxone is administered to opioid-naive patients with severe pain and those unsuccessfully treated with weak opioids. Oxycodone/naloxone may be also administered to patients treated with strong opioids who experience intense symptoms of OIBD. Studies conducted to date indicate that oxycodone/naloxone is an important drug in chronic pain management, prevention and treatment of OIBD.

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Prolonged-Release Oxycodone/Naloxone in Nonmalignant Pain: Single-Center Study in Patients with Constipation

Cited by 25 publications

References 21 publications

Opioid use for chronic pain management in Italy: results from the Orthopedic Instant Pain survey project

Opioid use for chronic pain management in Italy: results from the Orthopedic Instant Pain survey project

Oxycodone/Naloxone: Role in Chronic Pain Management, Opioid-Induced Constipation, and Abuse Deterrence

Reviews The place of oxycodone/naloxone in chronic pain management

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