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Abstract：
Introduction Naldemedine and magnesium oxide are common first-line early laxative medications used in the real-world scenario in Japan, for patients with cancer pain who receive opioid prescriptions, as per a nationwide hospital claims database study. However, the real-world prescription patterns and associated outcomes are unknown. Methods In this retrospective, cohort study using the Medical Data Vision (MDV) database (January 2018 to December 2020), data were collected from eligible patients (who had a long-term prescription of strong opioids, for >30 days) in Japan with naldemedine or magnesium oxide as the first-line laxative prescription, for a long-term opioid prescription for cancer pain with ≥6 months post-opioid observation period. A laxative prescription within three days after the opioid prescription date was termed an \"early\" prescription. The composite incidence of dose increase or addition/change of laxatives at three months after the start of the opioid prescription was the primary endpoint after adjusting baseline characteristics between the treatment arms by propensity score matching. Results After propensity score matching, 1717 and 544 patients who were prescribed naldemedine and magnesium oxide each were included in the early prescription and non-early prescription groups, respectively. Even after matching, the incidence of death was not adjusted enough and was significantly higher in the naldemedine arm than in the magnesium oxide arm in the non-early group but comparable in the early group. The incidence of addition, change, or dose increase was significantly higher in the naldemedine arm than in the magnesium oxide arm of the early prescription group (hazard ratio (95% confidence interval), 1.08 (1.00, 1.17); p=0.0402); the incidence was comparable between the arms of the non-early group. Conclusion These findings may provide valuable insights into real-world clinical treatment patterns and preliminary evidence for the selection of first-line medications to mitigate opioid-induced constipation in Japanese patients with cancer pain.
摘要：
Naldemedine和氧化镁是日本现实世界中常见的一线早期泻药，对于接受阿片类药物处方的癌症疼痛患者，根据全国医院索赔数据库研究。然而,真实世界的处方模式和相关结果未知.方法在这项回顾性研究中，使用医学数据视觉（MDV）数据库的队列研究（2018年1月至2020年12月），数据是从符合条件的患者(长期处方强阿片类药物，>30天）在日本使用纳地米定或氧化镁作为一线泻药处方，用于阿片类药物观察期后≥6个月的癌症疼痛的长期阿片类药物处方。阿片类药物处方日期后三天内的泻药处方被称为“早期”处方。在阿片类药物处方开始后三个月，剂量增加或添加/改变泻药的复合发生率是通过倾向评分匹配调整治疗组之间的基线特征后的主要终点。结果倾向评分匹配后，1717例和544例分别服用纳地米定和氧化镁的患者被纳入早期处方组和非早期处方组，分别。即使在匹配之后，在非早期组中,naldemedine组的死亡发生率未得到足够的调整,显著高于氧化镁组,但在早期组相当.加法的发生率，改变,或剂量增加显著高于早期处方组的氧化镁组（风险比（95%置信区间），1.08（1.00，1.17）；p=0.0402）；非早期组的手臂之间的发生率相当。结论这些发现可能为现实世界的临床治疗模式提供有价值的见解，并为选择一线药物以减轻日本癌痛患者的阿片类药物引起的便秘提供初步证据。
