Safety of Naldemedine for Opioid-Induced Constipation - A Systematic Review and Meta-Analysis.

Bastian Wobbe, Maximilian Gerner, Claus-Henning Köhne
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Abstract

Naldemedine is a peripheral acting µ-opioid receptor antagonist approved by the Food and Drug Administration to treat opioid-induced constipation. Concerns about side effects like opioid withdrawal prevent its widespread use, especially for cancer patients. We performed this systematic review and meta-analysis to evaluate existing safety data of naldemedine treating opioid-induced constipation following the PRISMA guidelines. We searched PubMed and the Cochrane Library on April 16th 2024 to identify studies evaluating naldemedine treatment among patients with opioid-induced constipation. Our analysis found no differences between groups comparing naldemedine therapy with placebo-control for treatment-emergent adverse events (OR = 1.06; 95%-CI: 0.91-1.24), serious adverse events (OR = 1.02; 95%-CI: 0.76-1.38). We found no increased risk for opioid withdrawal, while an increased risk for gastrointestinal disorders (OR = 2.08; 95%-CI: 1.72-2.51), particularly higher incidences of diarrhea (OR = 2.44; 95%-CI: 1.81-3.29) and abdominal pain (OR = 3.31; 95%-CI: 2.16-5.06) were found. In the cancer subgroup, treatment-emergent and serious adverse events were more frequent. However, no increased risk for opioid withdrawal was observed. This analysis confirms naldemedine's overall safety in treating opioid-induced constipation, with manageable gastrointestinal side effects. However, the higher adverse events in cancer patients require further investigation to ensure safe use in this population.

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纳德美定治疗阿片类药物引起的便秘的安全性:一项系统综述和荟萃分析。
Naldemedine是一种外周作用的微阿片受体拮抗剂,经美国食品和药物管理局批准用于治疗阿片类药物引起的便秘。对阿片类药物戒断等副作用的担忧阻止了它的广泛使用,尤其是对癌症患者。我们按照PRISMA指南进行了这项系统回顾和荟萃分析,以评估纳尔地美定治疗阿片类药物引起的便秘的现有安全性数据。我们于2024年4月16日检索PubMed和Cochrane图书馆,以确定评估naldemedine治疗阿片类药物引起的便秘患者的研究。我们的分析发现,在治疗后出现的不良事件方面,两组间比较纳尔地米定治疗与安慰剂对照无差异(OR = 1.06;95%-CI: 0.91-1.24),严重不良事件(OR = 1.02;95% ci: 0.76—-1.38)。我们发现阿片类药物戒断的风险没有增加,而胃肠道疾病的风险增加(OR = 2.08;95%-CI: 1.72-2.51),特别是腹泻的发生率较高(OR = 2.44;95% ci: 1.81-3.29)和腹痛(OR = 3.31;95%-CI: 2.16-5.06)。在癌症亚组中,治疗后出现的严重不良事件更为频繁。然而,没有观察到阿片类药物戒断的风险增加。该分析证实了纳尔地美定治疗阿片类药物引起的便秘的总体安全性,胃肠道副作用可控。然而,癌症患者较高的不良事件需要进一步调查,以确保在这一人群中安全使用。
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来源期刊
CiteScore
1.60
自引率
9.10%
发文量
40
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