Prolonged-release Oxycodone/Naloxone in Postoperative Pain Management: From a Randomized Clinical Trial to Usual Clinical Practice

Kuusniemi, Kristiina; Zöllner, Jan; Sjövall, S.; Huhtala, J.; Karjalainen, Pasi A.; Kokki, Merja; Lemken, Julia; Oppermann, Johannes; Kokki, Hannu

doi:10.1177/030006051204000516

Cited by 29 publications

(23 citation statements)

References 27 publications

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“…Controlled-release oxycodone formulations provide relatively constant plasma concentrations [11] and seem to be feasible options in the treatment of postoperative pain [12, 13]. Oxycodone-naloxone controlled-release tablets are increasingly used for postoperative pain in order to decrease the risk of OIC [14], and preliminary experience suggests that this combination may also decrease other opioid-induced adverse events, like urinary retention [13].…”

Section: Introductionmentioning

confidence: 99%

“…Oxycodone-naloxone controlled-release tablets are increasingly used for postoperative pain in order to decrease the risk of OIC [14], and preliminary experience suggests that this combination may also decrease other opioid-induced adverse events, like urinary retention [13]. Long-term efficacy and safety of oxycodone-naloxone has been demonstrated in palliative care, indicating that the combination product results in sustained analgesia, improved bowel function and improved symptoms of constipation [15].…”

Section: Introductionmentioning

confidence: 99%

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Opioid-Induced Bowel Dysfunction in Patients Undergoing Spine Surgery: Comparison of Oxycodone and Oxycodone-Naloxone Treatment

et al. 2016

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IntroductionOpioids are needed for postoperative pain in spine surgery patients, but opioid-induced constipation is a harmful adverse event. The aim of this clinical trial was to compare the use of a controlled-release oxycodone-naloxone combination product with oxycodone controlled-release tablets in these patients. The main outcome measure was the prevalence of constipation at 7 days postoperatively assessed with a Bowel Function Index questionnaire. A follow-up assessment at 21 days after surgery was also included.MethodsA total of 180 patients undergoing spine surgery, 91 having preoperative opioids in use and 89 opioid-naïve, were randomized to receive twice-daily oxycodone 10 mg or oxycodone-naloxone 10/5 mg controlled-release tablets for the first 7 postoperative days. Patients were followed-up for 21 days after surgery.ResultsAt baseline, prevalence of constipation was common both in the opioid-naïve—25/87 (29%) and on-opioid groups 43/90 (48%) (P = 0.009). This increased at 7 days postoperatively with no difference between the groups, 54/89 with oxycodone and 54/88 with oxycodone-naloxone had constipation. At 21 days, constipation was less than in the baseline in both groups, in the opioid-naïve group the prevalence of constipation was 3/43 (7%) in patients with oxycodone-naloxone compared to 9/44 (21%) with oxycodone (effect size 0.68; P = 0.068). Both study compounds provided similar pain relief and were well tolerated.ConclusionIn patients presented for back surgery, the prevalence of constipation was significantly higher than that in the community. In opioid-naïve subjects, oxycodone-naloxone was beneficial concerning constipation; but this was not distinguishable in subjects with chronic opioid use. The analgesic efficacy of oxycodone and oxycodone-naloxone was similar. Trial registration: European Clinical Trials Database (EudraCT no. 2012-001816-42) and ClinicalTrials.gov database (Identifier: NCT02573922).

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Opioid-Induced Bowel Dysfunction in Patients Undergoing Spine Surgery: Comparison of Oxycodone and Oxycodone-Naloxone Treatment

et al. 2016

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“…In four published studies, two showed equivocal results. However, two studies documented significant improvement in postoperative bowel functions, one also improved the passing of urine, an often neglected adverse effect of postoperative pain treatment with opioids [11][12][13]. The study by Comelon and co-workers [13] on bowel functions after laparoscopic hysterectomies did not find effects on postoperative bowel function when comparing OxyContin ® 10 mg without naloxone with OxyContin ® 10 mg with 5 mg naloxone added (= Targin ® , Targiniq ® , Targinact ® ) twice daily.…”

Section: Oral Prolonged Release Naloxonementioning

confidence: 99%

Oral immediate and prolonged release oxycodone for safe and effective patient controlled analgesia after surgery Can opioid for acute postoperative pain be improved by adding a peripheral opioid antagonist?

Ræder

Breivik

2015

Scandinavian Journal of Pain

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“…Four trials attempted to demonstrate noninferiority of OXN or co-administration of oxycodone and naloxone for analgesia, but failed to establish the boundary for inferiority or achieve adequate power in study design [13, 56, 61, 63]. Calculated P values between treatment arms of OXN and oxycodone PR did not achieve statistical significance, indicating failure to reject the null hypothesis for superiority rather than illustrating equivalence or noninferiority [64, 65].…”

Section: Oxycodone/naloxone Sustained Release Formulationsmentioning

confidence: 99%

“…Three published studies have addressed use of OXN for postoperative pain following orthopedic, gynecological, and cardiac surgery, with mixed results [63, 71, 72]. Improvement in bowel function has not been unequivocally demonstrated, potentially complicated by the low doses and brief treatment courses used and impact of gastrointestinal surgery on bowel function; analgesia was similar to intravenous (IV) opioids [63, 71, 72]. OXN is not recommended before surgery or for 12 to 24 h in the immediate postoperative period [46].…”

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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Prolonged-release Oxycodone/Naloxone in Postoperative Pain Management: From a Randomized Clinical Trial to Usual Clinical Practice

Cited by 29 publications

References 27 publications

Opioid-Induced Bowel Dysfunction in Patients Undergoing Spine Surgery: Comparison of Oxycodone and Oxycodone-Naloxone Treatment

Opioid-Induced Bowel Dysfunction in Patients Undergoing Spine Surgery: Comparison of Oxycodone and Oxycodone-Naloxone Treatment

Oral immediate and prolonged release oxycodone for safe and effective patient controlled analgesia after surgery Can opioid for acute postoperative pain be improved by adding a peripheral opioid antagonist?

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

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