Division of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, USA.
Pain Manag. 2020 Sep;10(5):301-306. doi: 10.2217/pmt-2020-0019. Epub 2020 Jun 19.
This review aims to summarize the efficacy data for naldemedine, a member of the novel peripherally acting μ-opioid receptor antagonists (PAMORAs), which gained US FDA approval for the treatment of opioid-induced constipation in adults with chronic noncancer pain-related syndromes in 2017. In Phase III trials, patients receiving naldemedine were significantly more likely to meet the primary end point ≥3 spontaneous bowel movements/week and an increase of ≥1 spontaneous bowel movement/week from baseline for at least 9/12 weeks compared to placebo (p < 0.0001). The most frequent adverse events were abdominal pain (8%) and diarrhea (7%). Based on available data, naldemedine appears to be an effective and safe first-line therapy for the treatment of opioid-induced constipation in adults with chronic noncancer pain.
本综述旨在总结纳洛美丁(naldemedine)的疗效数据,纳洛美丁是新型外周作用μ-阿片受体拮抗剂(PAMORAs)的成员,于 2017 年获得美国 FDA 批准,用于治疗慢性非癌痛相关综合征成人的阿片类药物诱发的便秘。在 III 期试验中,与安慰剂相比,接受纳洛美丁治疗的患者更有可能达到主要终点(每周至少有 3 次自发排便和基线时每周至少增加 1 次自发排便)(p < 0.0001)。最常见的不良事件是腹痛(8%)和腹泻(7%)。根据现有数据,纳洛美丁似乎是治疗慢性非癌痛成人阿片类药物诱发便秘的有效和安全的一线治疗药物。