Naldemedine for Opioid-Induced Constipation in Patients With Cancer: A Multicenter, Double-Blind, Randomized,...

Area of Science:

• Oncology
• Gastroenterology
• Clinical Pharmacology

Background:

• Opioid-induced constipation (OIC) is a common, persistent adverse effect of opioid analgesia.
• OIC negatively impacts patient adherence to pain management and overall quality of life.
• Effective strategies are needed to manage OIC in patients receiving opioid therapy.

Purpose of the Study:

• To evaluate the preventive efficacy of naldemedine compared to placebo for OIC in cancer patients initiating strong opioid therapy.
• To assess the impact of naldemedine on bowel function, quality of life, and opioid-induced nausea and vomiting (OINV).

Main Methods:

• A multicenter, double-blinded, randomized, placebo-controlled trial involving 99 cancer patients aged 20+ years starting strong opioids.
• Patients were randomized to receive either naldemedine (0.2 mg) or placebo for 14 days.
• The primary endpoint was the proportion of patients achieving a Bowel Function Index (BFI) <28.8 on day 14; secondary endpoints included spontaneous bowel movements (SBM), quality of life (QOL), and OINV frequency.

Main Results:

• Naldemedine significantly increased the proportion of patients with BFI <28.8 on day 14 (64.6%) compared to placebo (17.0%) (P < .0001).
• The naldemedine group showed statistically significant improvements in SBM frequency and QOL.
• A potential preventive effect on OINV was also observed in the naldemedine group.

Conclusions:

• Naldemedine effectively prevents OIC in cancer patients initiating strong opioid therapy.
• Naldemedine improves constipation-related quality of life and may reduce OINV.
• Naldemedine represents a valuable therapeutic option for managing OIC in this patient population.