期刊
JOURNAL OF CLINICAL MEDICINE
卷 11, 期 9, 页码 -出版社
MDPI
DOI: 10.3390/jcm11092672
关键词
clinical practice; efficacy; naldemedine; opioid-induced constipation
A multicenter, retrospective study was conducted to assess the effects of naldemedine on opioid-induced constipation in cancer patients. The results showed that naldemedine significantly increased the number of defecations and its efficacy and safety in clinical practice were comparable to prospective studies.
The efficacy and safety of naldemedine for opioid-induced constipation in patients with cancer has not been investigated in clinical practice. We conducted a multicenter, retrospective study to assess the effects of naldemedine among 10 Japanese institutions between June 2017 and August 2019. We evaluated the number of defecations 7 days before and after naldemedine administration. A total of 149 patients (89 male) with a median age of 72 years (range, 38-96) were included. The performance status was 0-1, 2, and >= 3 in 40, 38, and 71 patients, respectively. The median opioid dose in oral morphine equivalents was 30 mg/day (range: 7.5-800 mg). We observed 98 responders and 51 non-responders. The median number of defecations increased significantly in the 7 days following naldemedine administration from three to six (p < 0.0001). Multivariate analysis revealed that an opioid dose <30 mg/day [odds ratio, 2.08; 95% confidence interval, 1.01-4.32; p = 0.042] was significantly correlated with the effect of naldemedine. Diarrhea was the most common adverse event (38.2%) among all grades. The efficacy and safety of naldemedine in clinical practice are comparable to those of prospective studies, suggesting that it is effective in most patients.
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