Naldemedine Efficacious Against Opioid-Induced Constipation in Patients With Cancer

Naldemedine may increase defecation frequency in patients with cancer and poor performance status who have opioid-induced constipation, according to a multicenter, retrospective study published in Journal of Palliative Medicine.

Researchers collected electronic clinical data for patients at 10 Japanese institutions from June 7, 2017 to August 31, 2019.

Patients met inclusion criteria for the study if they had cancer with poor performance status (defined as an Eastern Cooperative Oncology Group Performance Status [ECOG-PS] score ≥ 3); were hospitalized for more than 7 days before and after naldemedine administration, during which time defecation frequency was measured; and used naldemedine concomitantly with opioids (N=71).

The number of defecations during the 1-week period before naldemedine administration was considered baseline data. Changes in defecation frequency before and after initiating naldemedine treatment were evaluated for all patients.

The patients were given 0.2 mg of naldemedine with opioids once daily and were considered responders if defecation frequency increased to 3 or more times per week.

Of the 71 patients, 66.1% were responders (95% CI, 54.5%–76.1%). Defecation frequency increased significantly in the overall population after naldemedine initiation (P < .0001) and in those whose baseline defecation frequency measured at less than 3 times a week before administration of naldemedine (P < .0001).

Diarrhea was the most common adverse event observed in the cohort.

Limitations of the study included its retrospective design and the subjective nature of the ECOG-PS assessment. In addition, the study lacked data on laxative use.

“This study demonstrated that naldemedine is efficacious and can be feasibly administered in a clinical practice setting to treat cancer patients with poor PS; it should therefore be considered for the treatment of [opioid-induced constipation] in such patients. Further validation in clinical practice is necessary,” the study authors concluded.