Evaluation of the efficacy and safety of TWHF in diabetic nephropathy patients with overt proteinuria and normal eGFR

Abstract

Background/purpose: The aim of this study was to evaluate the efficacy and safety of Tripterygium Wilfordii Hook F (TWHF) in DN patients with overt proteinuria and normal eGFR. Methods: 124 eligible DN patients were randomly assigned into two groups to receive either valsartan 160 mg/d treatment (control group) or TWHF 60 mg/d plus valsartan 160 mg/d treatments (TWHF group) for 24 weeks. The changes of clinical, biochemical data and adverse events during observation period were all analyzed. The primary endpoint was a reduction in 24-h urine protein excretion between baseline and the end of study, the secondary endpoint was to observe the change in estimated glomerular filtration rate (eGFR) between two groups. Results: After treatment, there was a more significant decrease in proteinuria in patients who received TWHF treatment (from 4.95 ± 1.27 g/24 h to 3.36 ± 0.83 g/24 h) compared to valsartan monotherapy (from 5.21 ± 1.59 g/24 h to 4.52 ± 1.06 g/24 h). The percentage change in urine protein excretion was −32.12% in TWHF group and −13.24% in valsartan group. Patients’ plasma albumin in TWHF group (from 32.53 ± 5.24 g/L to 36.91 ± 4.42 g/L) was higher than that in control group (from 33.18 ± 4.87 g/L to 34.67 ± 4.75 g/L). No significant change in blood pressure, blood glucose, eGFR, and serum potassium was observed. But the adverse events in TWHF group were higher than those in control group. Conclusion: TWHF is more effective than valsartan monotherapy in reduction of proteinuria in DN patients with overt proteinuria and normal eGFR, but with more adverse effects. Keywords: Diabetes mellitus, Diabetic nephropathy, Tripterygium wilfordii hook F, Valsartan