Naloxone as part of a prolonged release oxycodone/naloxone combination reduces oxycodone-induced slowing of gastrointestinal transit in healthy volunteers

Smith, Kevin J.; Hopp, Michael; Mundin, Gill; Bond, Simon; Bailey, Paul; Woodward, Jo; Palaniappan, K.; Church, Ann; Limb, Marie C.; Connor, Alyson

doi:10.1517/13543784.2011.563236

Cited by 47 publications

(35 citation statements)

References 17 publications

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“…11 For the PR naloxone period, our results are somewhat in contrast to a scintigraphic transit study by Smith et al, 22 who showed that a single dose of 10 mg PR naloxone in combination with 20 mg PR oxycodone significantly reduced colonic transit compared to PR oxycodone alone. The reason for this discrepancy between the studies remains obscure, but may reflect the different methodologies used to assess transit times.…”

Section: Gastrointestinal Transitcontrasting

confidence: 99%

“…The reason for this discrepancy between the studies remains obscure, but may reflect the different methodologies used to assess transit times. In our study, measurements rely on transport of a nondigestable solid, whereas Smith et al 22 used a radiolabelled resin to measure transit. Moreover, the dosage regimen and the drugs differed between the studies.…”

Section: Gastrointestinal Transitmentioning

confidence: 99%

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Colorectal Transit and Volume During Treatment With Prolonged-release Oxycodone/Naloxone Versus Oxycodone Plus Macrogol 3350

Poulsen

Mark

Brock

et al. 2018

J Neurogastroenterol Motil

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Background/AimsOpioid-induced constipation (OIC) is the most common gastrointestinal (GI) side effect to opioid treatment. Opioid receptor antagonists against OIC have been introduced, but their efficacy has not been directly compared to conventional laxatives. Our aim was to compare symptoms and objective parameters of gut function in an experimental model of OIC during treatment with the opioid antagonist naloxone and oxycodone in prolonged-release (PR) formulation versus oxycodone plus macrogol 3350. MethodsIn this randomized, double-blind, crossover trial 20 healthy men received a 5-day treatment of combined PR oxycodone/naloxone or PR oxycodone plus macrogol 3350. Regional GI transit times and segmental colorectal transit were assessed with the Motilis 3D-Transit electromagnetic capsule system. Colorectal volumes were determined by MRI. OIC symptoms were assessed with validated questionnaires, along with stool frequency and consistency. ResultsTotal colorectal volume did not change after 5 days' treatment with PR oxycodone/naloxone (941 vs 1036 mL; P = 0.091), but increased significantly after PR oxycodone plus macrogol treatment (912 vs 1123 mL; P < 0.001). Neither regional GI transit times nor segmental colorectal transit differed between the treatments (all P > 0.05). The Patient Assessment of Constipation Symptom Questionnaire abdominal symptoms score was lower during PR oxycodone/naloxone compared to PR oxycodone plus macrogol (0.2 vs 3.2; P = 0.002). Stool frequency was lower during PR oxycodone/naloxone compared to PR oxycodone plus macrogol (4.2 vs 5.4; P = 0.035). ConclusionsPR oxycodone plus macrogol increases colorectal volume, but does not improve GI transit compared to PR oxycodone/naloxone. However, PR oxycodone/naloxone results in a lower abdominal symptom burden, despite higher stool frequency during macrogol treatment.

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Section: Gastrointestinal Transitcontrasting

confidence: 99%

Section: Gastrointestinal Transitmentioning

confidence: 99%

Colorectal Transit and Volume During Treatment With Prolonged-release Oxycodone/Naloxone Versus Oxycodone Plus Macrogol 3350

Poulsen

Mark

Brock

et al. 2018

J Neurogastroenterol Motil

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“…The coadministration of OX and N optimal ratio in a fixed ratio of 2:1 did not significantly alter the bioavailability of either of its constituents [6]. A scintigraphic analysis showed that 20 mg of OX significantly increased colon arrival time and PR OXN 20/10 mg significantly reduced mean colonic transit time at values similar to placebo [7]. Two studies provided information about the optimal ratio of OX and N to obtain a significant improvement in bowel transit without influencing analgesia.…”

Section: Overview Of the Marketmentioning

confidence: 96%

Combined oral prolonged-release oxycodone and naloxone in chronic pain management

Mercadante

Giarratano

2012

Expert Opinion on Investigational Drugs

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“…Naloxone improved opioidinduced constipation symptoms and also reduced the laxative use with only mild opioid withdrawal symptoms such as yawning, sweating and shivering [Meissner et al 2000]. Naloxone PR reduced mean colonic transit time by 2.1 h when used in combination with oxycodone PR (20 mg oxycodone/10 mg naloxone) compared with oxycodone PR alone (20 mg) [Smith et al 2011]. …”

Section: Oxycodone and Naloxonementioning

confidence: 99%

Opioid-induced constipation: advances and clinical guidance

Nelson

Camilleri

2016

Therapeutic Advances in Chronic Disease

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Currently opioids are the most frequently used medications for chronic noncancer pain. Opioid-induced constipation is the most common adverse effect associated with prolonged use of opioids, having a major impact on quality of life. There is an increasing need to treat opioid-induced constipation. With the recent approval of medications for the treatment of opioid-induced constipation, there are several therapeutic approaches. This review addresses the clinical presentation and diagnosis of opioid-induced constipation, barriers to its diagnosis, effects of opioids in the gastrointestinal tract, differential tolerance to opiates in different gastrointestinal organs, medications approved and in development for the treatment of opioid-induced constipation, and a proposed clinical management algorithm for treating opioid-induced constipation in patients with noncancer pain.

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Naloxone as part of a prolonged release oxycodone/naloxone combination reduces oxycodone-induced slowing of gastrointestinal transit in healthy volunteers

Abstract: A single dose of oxycodone 20 mg significantly prolonged GI transit time but this effect was reduced by co-administration of naloxone.

Cited by 47 publications

References 17 publications

Colorectal Transit and Volume During Treatment With Prolonged-release Oxycodone/Naloxone Versus Oxycodone Plus Macrogol 3350

Colorectal Transit and Volume During Treatment With Prolonged-release Oxycodone/Naloxone Versus Oxycodone Plus Macrogol 3350

Combined oral prolonged-release oxycodone and naloxone in chronic pain management

Opioid-induced constipation: advances and clinical guidance

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