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二肽基肽酶-4 抑制剂与磺酰脲类药物在 2 型糖尿病合并晚期慢性肾脏病患者中的肾脏和心血管安全性比较。

Association of Renal and Cardiovascular Safety With DPP-4 Inhibitors vs. Sulfonylureas in Patients With Type 2 Diabetes and Advanced Chronic Kidney Disease.

机构信息

Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, Taiwan.

Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.

出版信息

Clin Pharmacol Ther. 2021 Aug;110(2):464-472. doi: 10.1002/cpt.2262. Epub 2021 May 11.

Abstract

This study assessed the effects of dipeptidyl peptidase-4 inhibitors (DPP4is) vs. sulfonylureas (SUs) on composite renal, cardiovascular, and hospitalized hypoglycemia outcomes in type 2 diabetes (T2D) patients with advanced chronic kidney disease (CKD) who were underrepresented in previous clinical studies. The National Health Insurance Research Database was utilized. Patients with T2D and advanced CKD (stages 3b-5) with stable use of DPP4is or SUs were identified during 2011-2015 and followed until death or December 31, 2016. The primary outcome was the composite renal outcome. Secondary outcomes included hospitalized heart failure (HHF), major adverse cardiovascular event (MACE), hospitalized hypoglycemia, and all-cause death. Subdistribution hazard models were employed to assess treatment effects on clinical outcomes. A total of 1,204 matched pairs of DPP4i and SU users were analyzed. Compared with SUs, DPP4is had no significant difference in the risks of the composite renal outcome, HHF, and three-point and four-point MACE (hazard ratios (95% confidence intervals): 1.10 (0.93-1.31), 1.11 (0.95-1.30), 0.97 (0.79-1.19), and 1.08 (0.94-1.24), respectively), but reduced risks of hospitalized hypoglycemia (0.53 (0.43-0.64)) and all-cause death (0.71 (0.53-0.96)). In conclusion, among patients with T2D and advanced CKD, the use of DPP4is vs. SUs was associated with comparable safety profiles on renal and cardiovascular outcomes, and reduced risks of hospitalized hypoglycemia and all-cause death. DPP4is may be preferred for patients with T2D and advanced CKD, and the regular monitoring on cardiac function remains crucial among this population who are at a higher risk of HHF.

摘要

本研究评估了二肽基肽酶-4 抑制剂(DPP4i)与磺酰脲类药物(SUs)在接受二肽基肽酶-4 抑制剂或磺酰脲类药物稳定治疗的 2 型糖尿病(T2D)合并晚期慢性肾脏病(CKD)患者中的复合肾脏、心血管和住院低血糖结局方面的影响,这些患者在之前的临床研究中代表性不足。使用了国家健康保险研究数据库。在 2011 年至 2015 年期间确定了 T2D 合并晚期 CKD(3b-5 期)且稳定使用 DPP4i 或 SUs 的患者,并随访至死亡或 2016 年 12 月 31 日。主要结局为复合肾脏结局。次要结局包括住院心力衰竭(HHF)、主要不良心血管事件(MACE)、住院低血糖和全因死亡。亚分布风险模型用于评估治疗对临床结局的影响。共分析了 1204 对 DPP4i 和 SU 使用者。与 SUs 相比,DPP4i 在复合肾脏结局、HHF 和三点和四点 MACE 的风险方面无显著差异(风险比(95%置信区间):1.10(0.93-1.31)、1.11(0.95-1.30)、0.97(0.79-1.19)和 1.08(0.94-1.24)),但住院低血糖(0.53(0.43-0.64))和全因死亡(0.71(0.53-0.96))的风险降低。总之,在 T2D 合并晚期 CKD 患者中,与 SUs 相比,使用 DPP4i 与肾脏和心血管结局的安全性相似,并且降低了住院低血糖和全因死亡的风险。DPP4i 可能更适合 T2D 合并晚期 CKD 的患者,而在该人群中,HFH 风险较高,因此定期监测心脏功能仍然至关重要。

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