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Abstract：
OBJECTIVE: To investigate the efficacy and safety of tadalafil (TAD) versus pentoxifylline (PTX) in the management of diabetic kidney disease (DKD). Some animal studies and clinical trials reported that tadalafil and pentoxifylline have a reducing effect on different blood glucose parameters and lipid profiles which contribute to progress the patients with diabetes mellitus (DM) to DKD.
METHODS: From February 2022 to March 2023, 90 patients with type 2 DM and DKD (micro-albuminuria) were enrolled in this randomized-controlled study. The patients were randomized into three equal groups: control group, TAD group, and PTX group. The three groups received traditional blood glucose lowering therapy + ramipril 10 mg PO. The TAD group also received tadalafil 20 mg PO every other day. The PTX group also received pentoxifylline 400 mg PO twice daily.
RESULTS: Both TAD and PTX groups produced statistically significant improvement in the primary outcomes by a significant reduction in Urinary albumin/creatinine ratio (UACR) which was pronounced by a reduction percentage of-47.47%, -53.73% respectively. In addition to a significant decrease in Hemoglobin A1C (HbA1c) (mmol/mol), Fasting blood glucose (FBG), 2-h postprandial blood glucose (2-h PPG) (p < 0.001). Only the PTX group showed a significant increase in Cr Cl and a significant decrease in S. Cr (p < 0.001). Only the TAD group showed a significant increase in high-density lipoprotein-cholesterol (HDL-C) (p < 0.001), while the PTX group showed a significant decrease in low-density lipoprotein-cholesterol (LDL-C) (p-value 0.011), and triglyceride (p-value 0.002). Both TAD and PTX groups showed a decrease in tumor necrosis factor-α (TNF-α) which was significant only in the PTX group (p < 0.001). There was a significant increase in malondialdehyde (MDA) (p < 0.001), and an increase in urinary neutrophil gelatinase-associated Lipocalin (uNGAL) (p-value 0.850, 0.014 respectively) which was significant only in the PTX group.
CONCLUSIONS: The use of tadalafil or pentoxifylline may serve as an effective adjuvant therapy for patients with diabetic kidney disease.
BACKGROUND: ClinicalTrials.gov identifier NCT05487755, July 25, 2022.
METHODS: From February 2022 to March 2023, 90 patients with type 2 DM and DKD (micro-albuminuria) were enrolled in this randomized-controlled study. The patients were randomized into three equal groups: control group, TAD group, and PTX group. The three groups received traditional blood glucose lowering therapy + ramipril 10 mg PO. The TAD group also received tadalafil 20 mg PO every other day. The PTX group also received pentoxifylline 400 mg PO twice daily.
RESULTS: Both TAD and PTX groups produced statistically significant improvement in the primary outcomes by a significant reduction in Urinary albumin/creatinine ratio (UACR) which was pronounced by a reduction percentage of-47.47%, -53.73% respectively. In addition to a significant decrease in Hemoglobin A1C (HbA1c) (mmol/mol), Fasting blood glucose (FBG), 2-h postprandial blood glucose (2-h PPG) (p < 0.001). Only the PTX group showed a significant increase in Cr Cl and a significant decrease in S. Cr (p < 0.001). Only the TAD group showed a significant increase in high-density lipoprotein-cholesterol (HDL-C) (p < 0.001), while the PTX group showed a significant decrease in low-density lipoprotein-cholesterol (LDL-C) (p-value 0.011), and triglyceride (p-value 0.002). Both TAD and PTX groups showed a decrease in tumor necrosis factor-α (TNF-α) which was significant only in the PTX group (p < 0.001). There was a significant increase in malondialdehyde (MDA) (p < 0.001), and an increase in urinary neutrophil gelatinase-associated Lipocalin (uNGAL) (p-value 0.850, 0.014 respectively) which was significant only in the PTX group.
CONCLUSIONS: The use of tadalafil or pentoxifylline may serve as an effective adjuvant therapy for patients with diabetic kidney disease.
BACKGROUND: ClinicalTrials.gov identifier NCT05487755, July 25, 2022.
摘要：
目的：探讨他达拉非（TAD）与己酮可可碱（PTX）治疗糖尿病肾病（DKD）的疗效和安全性。一些动物研究和临床试验报道，他达拉非和己酮可可碱对不同的血糖参数和血脂谱具有降低作用，这有助于糖尿病（DM）患者发展为DKD。
方法：从2022年2月至2023年3月，90例2型DM和DKD（微量白蛋白尿）患者纳入本随机对照研究。将患者随机分为3组:对照组,TAD组,和PTX组。三组均接受传统降糖治疗+雷米普利10mgPO。TAD组还每隔一天接受他达拉非20mgPO。PTX组还每天两次接受己酮可可碱400mgPO。
结果：TAD组和PTX组均通过尿白蛋白/肌酐比值（UACR）显着降低，显著降低了-47.47％，在主要结局方面有统计学意义的改善。-分别为53.73%。除了血红蛋白A1C（HbA1c）显着降低（mmol/mol），空腹血糖（FBG），餐后2小时血糖（2小时PPG）（p<0.001）。只有PTX组表现出CrCl的显著增加和S.Cr的显著降低(p<0.001)。只有TAD组显示高密度脂蛋白胆固醇（HDL-C）显着增加（p<0.001），而PTX组显示低密度脂蛋白胆固醇（LDL-C）显着降低（p值0.011），和甘油三酯（p值0.002）。TAD和PTX组均显示肿瘤坏死因子-α（TNF-α）降低，仅在PTX组中显着（p<0.001）。丙二醛(MDA)显著增加(p<0.001),尿中性粒细胞明胶酶相关脂质运载蛋白（uNGAL）增加（p值分别为0.850，0.014），仅在PTX组中显着。
结论：他达拉非或己酮可可碱可作为糖尿病肾病患者的有效辅助治疗。
背景：ClinicalTrials.gov标识符NCT05487755，2022年7月25日。
方法：从2022年2月至2023年3月，90例2型DM和DKD（微量白蛋白尿）患者纳入本随机对照研究。将患者随机分为3组:对照组,TAD组,和PTX组。三组均接受传统降糖治疗+雷米普利10mgPO。TAD组还每隔一天接受他达拉非20mgPO。PTX组还每天两次接受己酮可可碱400mgPO。
结果：TAD组和PTX组均通过尿白蛋白/肌酐比值（UACR）显着降低，显著降低了-47.47％，在主要结局方面有统计学意义的改善。-分别为53.73%。除了血红蛋白A1C（HbA1c）显着降低（mmol/mol），空腹血糖（FBG），餐后2小时血糖（2小时PPG）（p<0.001）。只有PTX组表现出CrCl的显著增加和S.Cr的显著降低(p<0.001)。只有TAD组显示高密度脂蛋白胆固醇（HDL-C）显着增加（p<0.001），而PTX组显示低密度脂蛋白胆固醇（LDL-C）显着降低（p值0.011），和甘油三酯（p值0.002）。TAD和PTX组均显示肿瘤坏死因子-α（TNF-α）降低，仅在PTX组中显着（p<0.001）。丙二醛(MDA)显著增加(p<0.001),尿中性粒细胞明胶酶相关脂质运载蛋白（uNGAL）增加（p值分别为0.850，0.014），仅在PTX组中显着。
结论：他达拉非或己酮可可碱可作为糖尿病肾病患者的有效辅助治疗。
背景：ClinicalTrials.gov标识符NCT05487755，2022年7月25日。
