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

Abstract

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. 124 eligible DN patients were randomly assigned into two groups to receive either valsartan 160mg/d treatment (control group) or TWHF 60mg/d plus valsartan 160mg/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. After treatment, there was a more significant decrease in proteinuria in patients who received TWHF treatment (from 4.95±1.27g/24h to 3.36±0.83g/24h) compared to valsartan monotherapy (from 5.21±1.59g/24h to 4.52±1.06g/24h). 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±5.24g/L to 36.91±4.42g/L) was higher than that in control group (from 33.18±4.87g/L to 34.67±4.75g/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. 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.