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      Pathophysiology and management of opioid-induced constipation: European expert consensus statement

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          Abstract

          Opioid-induced bowel dysfunction is a complication of opioid therapy, in which constipation is the most common and problematic symptom. However, it is frequently under-recognised and thus effective management is often not instituted despite a number of treatment options.

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          Most cited references 69

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          Naloxegol for opioid-induced constipation in patients with noncancer pain.

          Opioid-induced constipation is common and debilitating. We investigated the efficacy and safety of naloxegol, an oral, peripherally acting, μ-opioid receptor antagonist, for the treatment of opioid-induced constipation.
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            Opioid receptors in the gastrointestinal tract.

             Peter Holzer (2009)
            Opium is arguably one of the oldest herbal medicines, being used as analgesic, sedative and antidiarrheal drug for thousands of years. These effects mirror the actions of the endogenous opioid system and are mediated by the principal mu-, kappa- and delta-opioid receptors. In the gut, met-enkephalin, leu-enkephalin, beta-endorphin and dynorphin occur in both neurons and endocrine cells. When released, opioid peptides activate opioid receptors on the enteric circuitry controlling motility and secretion. As a result, inhibition of gastric emptying, increase in sphincter tone, induction of stationary motor patterns and blockade of peristalsis ensue. Together with inhibition of ion and fluid secretion, these effects cause constipation, one of the most frequent and troublesome adverse reactions of opioid analgesic therapy. Although laxatives are most frequently used to ameliorate opioid-induced bowel dysfunction, their efficacy is unsatisfactory. Specific antagonism of peripheral opioid receptors is a more rational approach. This goal is addressed by the use of opioid receptor antagonists with limited absorption such as oral prolonged-release naloxone and opioid receptor antagonists that do not penetrate the blood-brain barrier such as methylnaltrexone and alvimopan. Preliminary evidence indicates that peripherally restricted opioid receptor antagonists may act as prokinetic drugs in their own right.
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              Validation of the Bowel Function Index to detect clinically meaningful changes in opioid-induced constipation.

              The Bowel Function Index (BFI) is a clinician-administered, patient-reported, 3-item questionnaire to evaluate opioid-induced constipation in cancer and non-cancer chronic pain patients. The objective of the present analysis was to evaluate the psychometric characteristics of the BFI using data from clinical studies of oral prolonged release (PR) oxycodone/naloxone. OXN2401 was a multicenter, controlled, randomized, double-blind, parallel-group study including oral PR oxycodone combined with oral PR naloxone as well as oral PR oxycodone combined with corresponding naloxone placebo. OXN3401 and OXN3001 were 12-week multicenter, controlled, randomized, double-blind, parallel-group studies of a fixed combination of oral PR oxycodone/naloxone versus PR oxycodone. In addition, a placebo group was included in study OXN3401. BFI psychometric characteristics (reliability, reproducibility, convergent/known groups validity, and responsiveness) were evaluated. Demographic data (n=985) were comparable and analyses indicated a high degree of internal consistency (Cronbach's alpha >0.7). Change of less than 5 points in BFI was indicative of high reproducibility. Correlations between BFI item and total scores to stool frequency were statistically significant and in the low-to-moderate range (OXN2401 -0.23 to -0.29, p < 0.001; OXN3401 range -0.26 to -0.40, p < 0.001; OXN3001 -0.14 to -0.15, p < 0.05). Data indicate that a BFI score change of ≥12 points represents a clinically meaningful change in constipation. This publication for validation of BFI only includes data from three clinical trials. However, another publication of an additional specifically designed cross-sectional validation study is in preparation. The BFI is a valid and reliable instrument for the assessment of opioid-induced constipation in chronic pain patients. Psychometric analyses from clinical trials support the BFI's psychometric properties.
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                Author and article information

                Journal
                United European Gastroenterology Journal
                United European Gastroenterology Journal
                SAGE Publications
                2050-6406
                2050-6414
                October 03 2018
                February 2019
                December 14 2018
                February 2019
                : 7
                : 1
                : 7-20
                Affiliations
                [1 ]Institute of Applied Clinical Science, Keele University, Keele, UK
                [2 ]Department of Gastroenterology, Aalborg University Hospital, Aalborg, Denmark
                [3 ]Centre for Trauma and Neuroscience, Queen Mary University of London, London, UK
                [4 ]Division of Gastroenterology, Azienda Ospedaliera Universitaria Integrata, Verona, Italy
                [5 ]Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, USA
                [6 ]Department of Medical Sciences, University of Ferrara, Ferrara, Italy
                [7 ]Marymount University Hospital and Hospice, Curraheen, Ireland
                [8 ]Cork University Hospital, Wilton, Ireland
                [9 ]Leuven Centre for Algology and Pain Management, University of Leuven, Leuven, Belgium
                [10 ]Translational Research Center for Gastrointestinal Disorders (TARGID), University of Leuven, Leuven, Belgium
                Article
                10.1177/2050640618818305
                6374852
                30788113
                © 2019

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