Efficacy and safety of naldemedine for opioid-induced constipation in older patients with cancer: a retrospective study

Eur J Gastroenterol Hepatol. 2024 May 1;36(5):571-577. doi: 10.1097/MEG.0000000000002746. Epub 2024 Mar 4.

Abstract

Background: Opioids are pain relievers that are often associated with opioid-induced constipation (OIC) that worsens with age. We performed a multicenter, retrospective analysis on the efficacy and safety of naldemedine, an opioid receptor antagonist, in treating OIC in patients with cancer (age >75 years).

Methods: The electronic medical records of cancer patients who received naldemedine at 10 Japanese institutions between 7 June 2017 and August 31, 2019, were retrieved. Patients aged ≥75 years who were treated with naldemedine for the first time and hospitalized for at least 7 days before and after initiating naldemedine therapy were included in this analysis.

Results: Sixty patients were observed for at least 7 days before and after starting naldemedine. The response rate was 68.3%, and the frequency of bowel movements increased significantly after naldemedine administration in the overall population ( P < 0.0001) and among those who defecated <3 times/week before naldemedine administration ( P < 0.0001). Diarrhea was the most frequent adverse event in all grades, observed in 45% of patients, of which 92.6% were Grade 1 or 2. Grade 4 or higher adverse events, including death, were not observed.

Conclusion: Naldemedine exhibits significant efficacy and safety in OIC treatment in older patients with cancer.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Analgesics, Opioid / adverse effects
  • Constipation / chemically induced
  • Constipation / drug therapy
  • Humans
  • Naltrexone / analogs & derivatives*
  • Neoplasms* / complications
  • Neoplasms* / drug therapy
  • Opioid-Induced Constipation* / drug therapy
  • Retrospective Studies

Substances

  • naldemedine
  • Analgesics, Opioid
  • Naltrexone