Xu Ling, Chen Bo, Zhang Hua, Zhu Dan
Department of Cardiology, Peking University Third Hospital, NHC Key, Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Peking University, Beijing, China.
Research Center of Clinical Epidemiology, Peking University Third Hospital, Peking University, Beijing, China.
Front Endocrinol (Lausanne). 2024 Jan 11;14:1326611. doi: 10.3389/fendo.2023.1326611. eCollection 2023.
Angiotensin receptor/neprilysin inhibitor (ARNI) and sodium-glucose cotransporter 2 inhibitor (SGLT2i) have shown a significant protective role against cardiovascular diseases and type 2 diabetes mellitus (T2DM), and there is a growing proportion of patients who are undergoing combined therapy with the two drugs. However, the effect of this combination treatment on renal function has not yet been determined.
This study included 539 patients who were diagnosed with cardiovascular disease combined with T2DM. According to the use of SGLT2i and ARNI, patients were divided into the combination treatment group, SGLT2i group, ARNI group and control group. Primary outcomes were serum creatinine (Scr) and estimated glomerular filtration rate (eGFR) changes in the 6th month and 12th month.
In the ARNI group, no significant changes in Scr or eGFR were observed during the follow-up period, while the above indicators showed a trend of deterioration in the other three groups. The univariate analysis results showed that at 6 months of follow-up, the renal function indicators of patients treated with ARNI (either alone or in combination) were better than those treated with SGLT2i alone. After 12 months of follow-up, the Scr results were the same as before, while the difference in eGFR between groups disappeared. After multivariate analysis, in terms of delaying the progression of Scr, the ARNI group was superior to the other groups at the end of follow-up. No significant difference in eGFR was observed between groups during follow-up.
In patients with cardiovascular disease and T2DM, combination therapy with ARNI and SGLT2i did not show an advantage over monotherapy in delaying renal insufficiency progression, and renal function seems to be better preserved in patients treated with ARNI alone.
clinicaltrials.gov, identifier NCT05922852.
血管紧张素受体/中性肽链内切酶抑制剂（ARNI）和钠-葡萄糖协同转运蛋白2抑制剂（SGLT2i）已显示出对心血管疾病和2型糖尿病（T2DM）具有显著的保护作用，并且接受这两种药物联合治疗的患者比例正在增加。然而，这种联合治疗对肾功能的影响尚未确定。
本研究纳入了539例被诊断为心血管疾病合并T2DM的患者。根据SGLT2i和ARNI的使用情况，患者被分为联合治疗组、SGLT2i组、ARNI组和对照组。主要结局指标为第6个月和第12个月时血清肌酐（Scr）和估计肾小球滤过率（eGFR）的变化。
在ARNI组中，随访期间Scr或eGFR未观察到显著变化，而其他三组的上述指标呈恶化趋势。单因素分析结果显示，随访6个月时，接受ARNI治疗（单独或联合）的患者肾功能指标优于单独使用SGLT2i治疗的患者。随访12个月后，Scr结果与之前相同，而组间eGFR差异消失。多因素分析后，在延缓Scr进展方面，随访结束时ARNI组优于其他组。随访期间组间eGFR未观察到显著差异。
在患有心血管疾病和T2DM的患者中，ARNI和SGLT2i联合治疗在延缓肾功能不全进展方面未显示出优于单药治疗的优势，且单独使用ARNI治疗的患者肾功能似乎得到更好的保留。
clinicaltrials.gov，标识符NCT05922852。
