Safety of Naldemedine for Opioid-Induced Constipation–A Systematic Review and Meta-Analysis

Wobbe B, Gerner M, Köhne CH (2024)

Publication Type: Journal article, Review article

Publication year: 2024

Journal

Journal of Pain and Palliative Care Pharmacotherapy The Haworth Medical Press

DOI: 10.1080/15360288.2024.2427324

Abstract

Naldemedine is a peripheral acting µ-opioid receptor antagonist approved by the Food and Drug Administration to treat opioid-induced constipation. Concerns about side effects like opioid withdrawal prevent its widespread use, especially for cancer patients. We performed this systematic review and meta-analysis to evaluate existing safety data of naldemedine treating opioid-induced constipation following the PRISMA guidelines. We searched PubMed and the Cochrane Library on April 16th 2024 to identify studies evaluating naldemedine treatment among patients with opioid-induced constipation. Our analysis found no differences between groups comparing naldemedine therapy with placebo-control for treatment-emergent adverse events (OR = 1.06; 95%-CI: 0.91–1.24), serious adverse events (OR = 1.02; 95%-CI: 0.76–1.38). We found no increased risk for opioid withdrawal, while an increased risk for gastrointestinal disorders (OR = 2.08; 95%-CI: 1.72–2.51), particularly higher incidences of diarrhea (OR = 2.44; 95%-CI: 1.81–3.29) and abdominal pain (OR = 3.31; 95%-CI: 2.16–5.06) were found. In the cancer subgroup, treatment-emergent and serious adverse events were more frequent. However, no increased risk for opioid withdrawal was observed. This analysis confirms naldemedine’s overall safety in treating opioid-induced constipation, with manageable gastrointestinal side effects. However, the higher adverse events in cancer patients require further investigation to ensure safe use in this population.

Authors with CRIS profile

Maximilian Gerner Department of Medicine 1 – Gastroenterology, Pneumology and Endocrinology

Involved external institutions

Klinikum Oldenburg DE Germany (DE)

How to cite

APA:

Wobbe, B., Gerner, M., & Köhne, C.H. (2024). Safety of Naldemedine for Opioid-Induced Constipation–A Systematic Review and Meta-Analysis. Journal of Pain and Palliative Care Pharmacotherapy. https://doi.org/10.1080/15360288.2024.2427324

MLA:

Wobbe, Bastian, Maximilian Gerner, and Claus Henning Köhne. "Safety of Naldemedine for Opioid-Induced Constipation–A Systematic Review and Meta-Analysis." Journal of Pain and Palliative Care Pharmacotherapy (2024).

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