Multicenter placebo-controlled trial of naldemedine for opioid-induced constipation in patients with cancer

Opioid-induced constipation is a frequent and non-self limiting adverse effect opioid analgesia. A placebo-controlled trial af four academic centers in Japan evaluated naldemedine for opioid-induced constipation in patients with cancer pain. The primary endpoint was proportion of patients with Bowel Function Index of < 28.8 on day 14. This percentage was 64.6% (95% CI 51.1-78.1) in the naldemedine group versus 17.0% (6.3-27.8) in the placebo group. Naldemedine was also associated with better spontaneous bowel movements, quality of life, and frequency of opioid-induced nausea and vomiting. The authors conclude that naldemedine prevented constipation and improved constipation-related quality of life in patients with cancer starting regularly dosed opioids therapy.