Denosumab依从性对2型糖尿病合并骨质疏松患者肾功能和死亡率的影响

IF 3.1
Yu-Chuan Chang, Jian-Chih Chen, Sung-Yen Lin, Kun-Der Lin, Pei-Shan Ho, Chung-Hwan Chen, Yin-Chih Fu, Tien-Ching Lee
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摘要

2型糖尿病(T2DM)与骨质疏松和骨折的风险增加有关,而denosumab是一种非肾脏排泄的抗吸收药物,是治疗T2DM患者骨质疏松症的可行替代方案。本研究旨在探讨denosumab依从性、肾功能和T2DM合并骨质疏松患者全因死亡率之间的关系。从电子健康记录数据库中确定2010年至2017年期间的新denosumab用户,排除后,根据其2年药物依从性筛选和分析536名参与者:高依从性(HA)定义为3或4次剂量,低依从性(LA)定义为1或2次剂量。计算1年平均估计肾小球滤过率(eGFR),并使用Kaplan-Meier曲线和Cox回归模型分析全因死亡率。该研究分别纳入了HA组和LA组的286名和250名受试者,尽管两组的eGFR均有所下降,但两组之间的肾功能仍具有可比性。与LA组相比,HA组的全因死亡率显著降低(校正风险比:0.52,95%可信区间:0.29-0.92)。研究发现,在T2DM和骨质疏松患者中,高程度的地诺单抗依从性与全因死亡风险较低相关,而不会显著影响肾功能,这突出了在这一高危人群中维持常规地诺单抗治疗的潜在益处。然而,这项观察性研究的设计表明了关联而不是因果关系,需要进一步的前瞻性研究来验证这些结果并阐明本研究中观察到的关系的潜在机制。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Impact of Denosumab Adherence on Renal Function and Mortality Rates in Type 2 Diabetes Patients With Osteoporosis.

Type 2 diabetes mellitus (T2DM) is associated with an increased risk of osteoporosis and fractures, and denosumab, a non-kidney-excreted antiresorptive medication, represents a viable alternative to bisphosphonates for osteoporosis treatment in patients with T2DM. This study aimed to investigate the association among denosumab adherence, renal function, and all-cause mortality in patients with T2DM and osteoporosis. New denosumab users between 2010 and 2017 were identified from an electronic health record database, and after exclusion, 536 participants were screened and analyzed based on their 2-year drug adherence: high adherence (HA) defined as three or four doses, and low adherence (LA) defined as one or two doses. The 1-year average estimated glomerular filtration rate (eGFR) was calculated, and all-cause mortality was analyzed using Kaplan-Meier curves and Cox regression models. The study included 286 and 250 subjects in the HA and LA groups, respectively, and although eGFR declined in both groups, renal function remained comparable between the groups. The all-cause mortality rate was significantly lower in the HA group compared to the LA group (adjusted hazard ratio: 0.52, 95% confidence interval: 0.29-0.92). High denosumab adherence was found to be associated with a lower risk of all-cause mortality among patients with T2DM and osteoporosis without significantly impacting renal function, highlighting the potential benefits of maintaining regular denosumab treatment in this high-risk population. Nevertheless, this observational study design indicates association rather than causation, and further prospective research is warranted to validate these results and elucidate the mechanisms underlying the relationships observed in this study.

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