The effectiveness and safety of naldemedine in treating opioid-induced constipation among non-cancer adult patients: updated meta-analysis.

INTRODUCTION

This meta-analysis evaluated the efficacy and safety of naldemedine for treating opioid-induced constipation (OIC) in non-cancer patients, focusing on SBM, serious TEAEs, GI side effects, opioid withdrawal, and other adverse events (AEs).

METHODS

A systematic review was conducted using PubMed, ScienceDirect, CINAHL, and the Cochrane Library. Two reviewers independently screened studies, extracted data, and assess methodological quality. Pooled risk ratios (RRs) and 95% confidence intervals (CIs) were calculated. A random-effects model was applied to analyze outcomes using Review Manager 5.3.

RESULTS

Eight RCTs from six studies were included, with 3879 patients in the intervention group and 3868 in the control group. Naldemedine significantly increased the incidence of serious TEAEs (RR = 1.07; 95% CI: 1.00-1.14, p < 0.05), drug-related adverse events (RR = 1.44, 95% CI: 1.26-1.65, p < 0.05), GI adverse events (RR = 1.61, 95% CI: 1.40-1.86, p < 0.0), and opioid withdrawal-related events (RR = 1.65, 95% CI: 1.42-1.91, p < 0.05). Specific AEs include abdominal pain (RR = 3.71, CI: 2.87-3.71, p < 0.01), nausea (RR = 1.51, CI: 1.38-1.65, p < 0.01), and diarrhea (RR = 2.57, CI: 2.08-3.16, p < 0.01) were also significantly higher in the naldemedine group.

CONCLUSIONS

Naldemedine 0.2 mg is effective for treating OIC in non-cancer patients and is generally well tolerated, with primarily mild-moderate AEs. Further studies should explore long-term safety and comparisons with other PAMORAs.This review was registered in the PROSPERO databases (CRD42023472575).