scholarly journals Comparison of efficacy and safety of three novel hypoglycemic agents in patients with severe diabetic kidney disease

Author(s):  
Yijun Li ◽  
◽  
Ying Hu ◽  
Kang Chen ◽  
Bing Li ◽  
...  
2021 ◽  
Author(s):  
Jingxin Zhou ◽  
Wenhua Zhang ◽  
Jie Yang ◽  
Qiaoqiao Liu ◽  
Yizhen Lu ◽  
...  

Abstract Background: Diabetic kidney disease (DKD), which is a serious complication of diabetes and the leading cause of end-stage renal disease, becomes a major health concern worldwide. Keluoxin capsule, a Chinese patent medicine used for DKD, has been widely used in diabetic kidney disease, but its efficacy and safety have not yet been clarified. Therefore, the aim of this systematic review and meta-analysis is to summarize the efficacy and safety of Keluoxin capsule in the treatment of DKD. Methods: A systematic literature search will be conducted in PubMed, Cochrane Library, EMBASE, China National Knowledge Infrastructure, WANFANG database, VIP, SinoMED, and Chinese Biomedical Literature Database (CBM) to ensure all possible randomized controlled trials (RCT) studies on K eluoxin capsule to November 1, 2021. The primary outcome to be assessed will include the change in albuminuria and estimated glomerular filtration rate (eGFR), while secondary outcomes will be serum creatinine, blood urea nitrogen, glycated hemoglobin, total cholesterol, low-density lipoprotein cholesterol, and triglycerides, etc and adverse events. The quality of the included studies and the risk of bias will be independently assessed by two reviewers using the risk of bias assessment tool from Cochrane Handbook. We will conduct random-effects model meta-analysis using Review Manager software (Revman5.3). Discussion: This systematic review and meta-analysis will objectively evaluate the effect of Keluoxin capsule for DKD, and provide evidence for Keluoxin capsule in the treatment of DKD. Ethics and dissemination : Ethics approval is not required for this study. We aim to publish the results of this systematic review in a peer-reviewed journal. INPLASY registration number: INPLASY 2021110067.


Author(s):  
Yaning Zheng ◽  
Sheng Ma ◽  
Qiaomu Huang ◽  
Yu Fang ◽  
Hongjin Tan ◽  
...  

Background: The Phase III clinical trial of the non-steroidal mineralocorticoid receptor antagonist finerenone (BAY 94-8862) has been completed, aiming to investigate renal and cardiovascular (CV) outcomes in type 2 diabetes (T2D) with chronic kidney disease (CKD). However, the efficacy and safety of finerenone in renal function remain controversial. The purpose of this study was to explore the efficacy and safety of finerenone in treating the patients with diabetic kidney disease (DKD). Methods: Databases of PubMed, Cochrane Library, Embase, and Web of Science were searched for randomized controlled trials (RCTs) on patients with DKD receiving finerenone treatment from inception to September 2021. Data including patient characteristics and interested outcomes were extracted, and the dichotomous data and continuous variables were evaluated using risk ratio (RR) with 95% confidence intervals (CIs) and mean differences (MD) with 95% CIs, respectively. Results: A total of 4 RCTs involving 13945 patients were included in this meta-analysis. Analysis results demonstrated that patients receiving finerenone showed a significant decrease in changing urinary albumin-to-creatinine ratio (UACR) from baseline (MD: ﹣0.30; 95%CI [﹣0.33, ﹣0.27] P=0.46, I2=0%) (P<0.05). The number of patients with ≥40% reduction in estimated glomerular filtration rate (eGFR) from baseline in the finerenone group was significantly smaller than that in the placebo group (RR: 0.85; 95%CI [0.78, 0.93] P=0.60, I2=0%) (P<0.05). No difference was found in adverse events between the finerenone and placebo groups (RR: 1.00; 95%CI [0.98, 1.01] P = 0.94, I2=0%) (P=0.65). The incidence of hyperkalemia was higher in the finerenone group than that in the placebo group (RR: 2.03; 95%CI [1.83, 2.26] P = 0.95, I2=0%) (P<0.05). Conclusion: Finerenone contributes to the reduction of UACR and can ameliorate the deterioration of renal function in patients with T2D and CKD. The higher risk of hyperkalemia was found in the finerenone group compared with placebo, however, there was no difference in the risk of overall adverse events.


2020 ◽  
Author(s):  
Yebei Li ◽  
Zhipeng Yan ◽  
Kang Wang ◽  
Tianlun Huang ◽  
Xin Liu ◽  
...  

Abstract Background: The present study aims to explore the relative efficacy and safety of Yi-Shen-Hua-Shi (YSHS) granule in diabetic kidney disease (DKD) patients. Methods: A total of 260 DKD patients with the urinary albumin-to-creatinine ratio (UACR) ≥ 30 mg/g and estimated glomerular filtration rate (eGFR) > 30 ml/min/1.73 m2 were included. 130 patients receiving YSHS plus irbesartan and 130 patients with irbesartan alone. The primary outcomes were included serum creatinine (Scr), 24-hour urinary protein (24h UTP), UACR, and the overall response rate (ORR). The secondary outcomes included fasting blood glucose (FBG), hemoglobin A1c (HbA1c), total cholesterol (TC), triglyceride (TG), and low-density lipoprotein (LDL-C). Results: At the end of 12 weeks, compared with the controls, the YSHS group could effectively improve the level of 24h UTP (P = 0.007), UACR (P = 0.001), FBG (P = 0.024), HbA1c (P = 0.005), TC (P = 0.018), TG (P = 0.001), and LDL-C (P = 0.034). The ORR in the YSHS group and control group was 47 % versus 30 % at 12 weeks (P = 0.005), respectively. There was no statistical difference in major adverse reactions between the two groups during treatment.Conclusions: The YSHS granule has significant curative effects on DKD, especially in reducing proteinuria, improving blood glucose and lipid metabolism, with no obvious adverse reactions.


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