PT  - JOURNAL ARTICLE
AU  - Bastian Wobbe
AU  - Maximilian Gerner
AU  - Claus-Henning Köhne
TI  - Naldemedine versus placebo in opioid-induced constipation: a meta-analysis
AID  - 10.1136/spcare-2022-003896
DP  - 2023 Dec 01
TA  - BMJ Supportive & Palliative Care
PG  - e578--e584
VI  - 13
IP  - e3
4099  - http://spcare.bmj.com/content/13/e3/e578.short
4100  - http://spcare.bmj.com/content/13/e3/e578.full
SO  - BMJ Support Palliat Care2023 Dec 01; 13
AB  - Objective Opioid-induced constipation (OIC) is a frequent adverse event among patients receiving chronic pain therapy that is requiring opioids. Naldemedine was approved by the Food and Drug Administration to treat OIC and appears to be more efficient than any other peripherally acting µ-opioid receptor antagonist. This meta-analysis aimed at assessing the available data on naldemedine in terms of efficacy.Methods We searched the Cochrane Library, PubMed and ClinicalTrials on 24 May 2022 to identify randomised controlled trials (RCTs) comparing naldemedine to placebo among patients reporting OIC.Results Evaluation of 6 RCTs enrolling 2769 participants showed significantly greater respondence to treatment (OR=2.48; 95% CI: 2.02 to 3.06; p<0.00001), change in weekly spontaneous bowel movements (SBMs) (mean difference=1.45; 95% CI: 1.14 to 1.76; p<0.00001), complete SBMs (mean difference=0.89; 95% CI: 0.62 to 1.17; p<0.00001) and SBMs without straining (mean difference=0.89; 95% CI: 0.61 to 1.17; p<0.00001) for patients treated with naldemedine. We found no difference in numeric pain rating scales after one (mean difference=0.05; 95% CI: −0.22 to 0.31; p=0.73) and two weeks of treatment (mean difference= −0.04; 95% CI: −0.31 to 0.22; p=0.75). Funding and clinical diversity were possible risks of bias.Conclusions Naldemedine improves a variety of bowel function parameters while preserving analgesia, confirming its efficacy for patients with OIC. However, head-to-head trials are needed to establish naldemedine as treatment of first choice for laxative-refractory OIC.PROSPERO registration number CRD42022281353.Data are available in a public, open access repository. All data relevant to the study are included in the article or uploaded as online supplemental information.