Center for Experiential Pharmacy Practice, School of Pharmacy, Tokyo University of Pharmacy and Life Science, Tokyo, Japan;, Email:
Center for Experiential Pharmacy Practice, School of Pharmacy, Tokyo University of Pharmacy and Life Science, Tokyo, Japan.
Pharmazie. 2021 Oct 1;76(10):515-518. doi: 10.1691/ph.2021.1624.
The incidence of hyperglycemia and diabetes induced by everolimus has been shown in previous studies. Our study analyzed diabetes time-to-onset profiles after everolimus use in patients who underwent transplantation and patients with cancer. Using data from April 2007 to December 2018 in the Japanese Adverse Drug Event Report database, the reports with everolimus were classified according to its use as an immunosuppressant or anticancer drug. The median (25%-75%) days of diabetes time-to-onset in patients who underwent transplantation and patients with cancer were 172 (56-315) and 32 (18.5-57), respectively. There were no significant variations among patients with breast cancer, neuroendocrine tumor, and renal cell carcinoma. By conducting a Weibull shape parameter test, the lower limits of the 95% confidence intervals of the shape parameter β values for the indications of the cancer types were >1, indicating the wear out failure type profile, whereas those for transplantation data indicated a random failure type profile. The diabetes time-to-onset profiles after everolimus use differed between usage as an anticancer drug and immunosuppressant and there were no significant variations among the type of cancer. It was suggested that the incidence of diabetes should be monitored for 1-2 months in patients with cancer, whereas continuous monitoring is needed in patients who undergo transplantation.
在先前的研究中已经显示依维莫司可导致高血糖和糖尿病。我们的研究分析了接受移植和患有癌症的患者使用依维莫司后糖尿病发病时间的分布。使用 2007 年 4 月至 2018 年 12 月期间日本药品不良反应报告数据库中的数据，根据其作为免疫抑制剂或抗癌药物的用途对报告中的依维莫司进行分类。接受移植和患有癌症的患者的糖尿病发病时间中位数（25%-75%）分别为 172（56-315）和 32（18.5-57）天。乳腺癌、神经内分泌肿瘤和肾细胞癌患者之间无显著差异。通过进行威布尔形状参数检验，癌症类型适应证的形状参数β值的 95%置信区间下限>1，表明为耗损失效类型分布，而移植数据则表明为随机失效类型分布。依维莫司作为抗癌药物和免疫抑制剂使用后糖尿病发病时间的分布不同，且癌症类型之间无显著差异。建议在癌症患者中监测 1-2 个月的糖尿病发病情况，而在接受移植的患者中需要持续监测。
