Yang Xinyue, Jin Jingjing, Cheng Meijuan, Xu Jinsheng, Bai Yaling
Department of Nephrology, Hebei Key Laboratory of Vascular Calcification in Kidney Disease, Hebei Clinical Research Center for Chronic Kidney Disease, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
Ren Fail. 2024 Dec;46(1):2349135. doi: 10.1080/0886022X.2024.2349135. Epub 2024 Jun 13.
This study aimed to investigate the efficacy and safety of sacubitril/valsartan in abnormal renal function (eGFR < 60 ml/min/1.73m) patients combined with heart failure based on randomized controlled trials (RCTs) and observational studies.
The Embase, PubMed and the Cochrane Library were searched for relevant studies from inception to December 2023. Dichotomous variables were described as event counts with the odds ratio (OR) and 95% confidence interval (CI) values. Continuous variables were expressed as mean standard deviation (SD) with 95% CIs.
A total of 6 RCTs and 8 observational studies were included, involving 17335 eGFR below 60 ml/min/1.73m patients combined with heart failure. In terms of efficacy, we analyzed the incidence of cardiovascular events and found that sacubitril/valsartan significantly reduced the risk of cardiovascular death or heart failure hospitalization in chronic kidney disease (CKD) stages 3-5 patients with heart failure (OR: 0.65, 95%CI: 0.54-0.78). Moreover, sacubitril/valsartan prevented the serum creatinine elevation (OR: 0.81, 95%CI: 0.68-0.95), the eGFR decline (OR: 0.83, 95% CI: 0.73-0.95) and the development of end-stage renal disease in this population (OR:0.73, 95%CI:0.60-0.89). As for safety outcomes, we did not find that the rate of hyperkalemia (OR:1.31, 95%CI:0.79-2.17) and hypotension (OR:1.57, 95%CI:0.94-2.62) were increased in sacubitril/valsartan group among CKD stages 3-5 patients with heart failure.
Our meta-analysis proves that sacubitril/valsartan has a favorable effect on cardiac function without obvious risk of adverse events in abnormal renal function patients combined with heart failure, indicating that sacubitril/valsartan has the potential to become perspective treatment for these patients.
本研究旨在基于随机对照试验（RCT）和观察性研究，探讨沙库巴曲缬沙坦在合并心力衰竭的肾功能异常（估算肾小球滤过率[eGFR]<60ml/min/1.73m²）患者中的疗效和安全性。
检索Embase、PubMed和Cochrane图书馆，查找从创刊至2023年12月的相关研究。二分类变量以事件计数描述，并给出比值比（OR）和95%置信区间（CI）值。连续变量以均数±标准差（SD）及95%CI表示。
共纳入6项RCT和8项观察性研究，涉及17335例eGFR低于60ml/min/1.73m²且合并心力衰竭的患者。在疗效方面，我们分析了心血管事件的发生率，发现沙库巴曲缬沙坦显著降低了3-5期慢性肾脏病（CKD）合并心力衰竭患者心血管死亡或心力衰竭住院的风险（OR：0.65，95%CI：0.54-0.78）。此外，沙库巴曲缬沙坦可防止该人群血清肌酐升高（OR：0.81，95%CI：0.68-0.95）、eGFR下降（OR：0.83，95%CI：0.73-0.95）以及终末期肾病的发生（OR：0.73，95%CI：0.60-0.89）。在安全性方面，我们未发现3-5期CKD合并心力衰竭患者中，沙库巴曲缬沙坦组高钾血症发生率（OR：1.31，95%CI：0.79-2.17）和低血压发生率（OR：1.57，95%CI：0.94-2.62）增加。
我们的荟萃分析证明，沙库巴曲缬沙坦对合并心力衰竭的肾功能异常患者的心功能有良好影响，且无明显不良事件风险，表明沙库巴曲缬沙坦有潜力成为这些患者的理想治疗药物。
