Wu Ping-Hsun, Lin Ming-Yen, Huang Teng-Hui, Lee Tien-Ching, Lin Sung-Yen, Chen Chung-Hwan, Kuo Mei-Chuan, Chiu Yi-Wen, Chang Jer-Ming, Hwang Shang-Jyh
Department of Internal Medicine, Division of Nephrology, Kaohsiung Medical University Hospital, Kaohsiung 80756, Taiwan.
Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung 80708, Taiwan.
J Pers Med. 2022 Jan 31;12(2):185. doi: 10.3390/jpm12020185.
Denosumab is approved for osteoporosis treatment in subjects with and without chronic kidney disease (CKD). Confirmation is required for its safety, treatment adherence, renal function effect, and mortality in patients with CKD. A retrospective cohort study was conducted to compare new users of denosumab in terms of their two-year drug adherence in all participants (overall cohort) and CKD participants (CKD subcohort), which was defined as baseline estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m. The eGFR was calculated using the 2021 CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation. We defined high adherence (HA) users as receiving three or four doses and low adherence (LA) users as receiving one or two doses. All-cause mortality was analyzed using Kaplan-Meier curves and Cox regression models. In total, there were 1142 subjects in the overall cohort and 500 subjects in the CKD subcohort. HA users had better renal function status at baseline than LD users in the overall cohort. A decline in renal function was only observed among LD users in the overall cohort. In the CKD subcohort, no baseline renal function difference or renal function decline was demonstrated. The all-cause mortality rate of HA users was lower than LA users in both the overall cohort and CKD. A randomized control trial is warranted to target this unique population to confirm our observations.
地诺单抗被批准用于治疗患有和未患有慢性肾脏病（CKD）的骨质疏松症患者。需要确认其在CKD患者中的安全性、治疗依从性、对肾功能的影响以及死亡率。进行了一项回顾性队列研究，比较了所有参与者（总体队列）和CKD参与者（CKD亚组）中地诺单抗新使用者的两年药物依从性，CKD亚组定义为基线估计肾小球滤过率（eGFR）低于60 mL/min/1.73 m²。eGFR使用2021年CKD-EPI（慢性肾脏病流行病学协作组）方程计算。我们将高依从性（HA）使用者定义为接受三剂或四剂药物的使用者，低依从性（LA）使用者定义为接受一剂或两剂药物的使用者。使用Kaplan-Meier曲线和Cox回归模型分析全因死亡率。总体队列中共有1142名受试者，CKD亚组中有500名受试者。在总体队列中，HA使用者在基线时的肾功能状况优于LA使用者。仅在总体队列中的LA使用者中观察到肾功能下降。在CKD亚组中，未显示出基线肾功能差异或肾功能下降。总体队列和CKD中，HA使用者的全因死亡率均低于LA使用者。有必要针对这一独特人群进行一项随机对照试验，以证实我们的观察结果。
