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Войти в исследования Expert opinion on drug safety · 2026
The effectiveness and safety of naldemedine in treating opioid-induced constipation among non-cancer adult patients: updated meta-analysis.
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Alnaeem Mohammad M, Suleiman Khaled H
Аннотация
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).
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).