The effectiveness and safety of naldemedine in treating opioid-induced constipation among non-cancer adult patients: updated meta-analysis.
Mohammad M Alnaeem, Khaled H Suleiman
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In 30 seconds
This systematic review and meta-analysis assessed naldemedine for opioid-induced constipation in non-cancer adults, pooling eight randomised controlled trials from six studies. Compared with control, naldemedine was associated with more serious treatment-emergent adverse events (RR = 1.07; 95% CI: 1.00-1.14) and higher rates of drug-related, gastrointestinal, and opioid withdrawal-related events. The authors concluded that naldemedine 0.2 mg is effective and generally well tolerated, with adverse events primarily mild to moderate; however, the abstract does not report a quantitative efficacy estimate.
Key findings
- Serious treatment-emergent adverse events were more frequent with naldemedine (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) and gastrointestinal adverse events (RR = 1.61, 95% CI: 1.40-1.86) increased with naldemedine.
- Opioid withdrawal-related events were more frequent with naldemedine (RR = 1.65, 95% CI: 1.42-1.91).
- The authors concluded that naldemedine 0.2 mg is effective for opioid-induced constipation, with adverse events primarily mild to moderate.
Why it matters
The review brings together randomised-trial evidence on both constipation treatment and safety in non-cancer patients receiving opioids. Its findings highlight that a treatment considered effective may also increase gastrointestinal symptoms and withdrawal-related events, alongside a small increase in serious treatment-emergent events. Weighing these outcomes is relevant when considering the overall benefit–harm profile.
What to keep in mind
The abstract does not provide a pooled quantitative efficacy result or details on follow-up duration, limiting assessment of the magnitude and longer-term balance of benefits and harms.