Author: Leo
Keywords: IgA nephropathy, mycophenolate mofetil, prednisone
IgA nephropathy (IgAN) is a common clinical glomerular disease, is also an important cause of global renal failure; clinical manifestations, from solitary hematuria - acute renal failure ranging. At present, what type of patients need what kind of immunosuppressive agents and the timing of treatment is still a major problem faced by clinicians.
Recently, a multicentre randomized controlled trial was conducted to compare the efficacy and safety of mycophenolate mofetil (MMF) + prednisone combination therapy with complete prednisone in the treatment of proliferative IgA nephropathy (active disease) The
The study included 176 patients with IgAN with active proliferative lesions (cell and fibrous crescent, capillary endothelial cell hyperplasia or necrosis), proteinuria (urinary protein excretion ≥ 1.0 g / 24 h, estimated glomerular Filtration rate> 30 mL / min / 1.73 m2). Were randomly divided into MMF group (n = 87) and prednisone group (n = 89). MMF group: given MMF 1.5 g / d treatment for 6 months + prednisone 0.4-0.6 mg / kg / d treatment for 2 months, after 20% per month for 4 months; prednisone group: prednisone 0.8-1.0 mg / kg / d treatment for 2 months, after a monthly reduction of 20% for 4 months. Primary end point: 6 months and 12 months complete remission rate.
The main result
At the 6th month of follow-up, the complete remission rate was 37% (95% CI: 27% -48%) in the MMF group and 38% (95% CI: 27% -49%) in the prednisone group. There was no statistically significant difference between the two groups (P = 0.9), and further sensitivity analysis showed no significant statistical difference between the two groups. Subgroup analysis (gender, age, hypertension, body mass index, serum albumin levels, eGFR, hypercholesterolemia, hypertriglyceridemia, and proliferative and sclerotic lesions) were also not statistically significant.
6 months and 12 months full response rate and total response rate
Complete response rate Kaplan Meier analysis
The median time to complete remission in the MMF group was 8.7 months (95% CI: 6.0-9.3) and the prednisone group was 8.5 months (95% CI: 4.2-9.3) (difference 0.2 months, 95% CI : -2.8-3.4, P = 0.6). The total response rate was 63% (95% CI: 65% -85%) in the MMF group and 81% (95% CI: 71% -89%) in the prednisone group. There was no statistically significant difference between the two groups (P = 0.5).
The cumulative dose of prednisone in the MMF group was 4,360 mg and the prednisone group was 6,970 mg (difference -2,610.0 [95% CI: -2,952.5 to -2,024.4] mg, P <0.001).
The complete remission rate was 95% (95% CI: 36% -60%) in the MMF group and 53% (95% CI: 41% -65%) in the prednisone group at the 12th month of follow-up -5; 95% CI: -21% -12%, P = 0.6). The total response rate in the MMF group was 82% (95% CI: 72% -90%), and the prednisone group was 85% (95% CI: 74% -92%) (difference -3,95% CI: % -14%, P = 0.7)
There was no significant difference in the overall incidence of adverse events between the two groups (78% vs 77%). There was no significant difference in the incidence of adverse events (6% vs 7%). (18% vs 48%, [difference: -29, 95% CI: -43 to -15]) and the incidence of new-onset diabetes (1% vs 14%, [Differences in the incidence of diabetes mellitus : -13,95% CI: -27-2]) was significantly lower than the prednisone group.
"The results of this study show that there is no statistically significant difference in total remission rate between MMF + prednisone and prednisone in patients with proliferative IgAN, but the incidence of adverse events in patients receiving MMF + prednisone is low," the researchers conclude. "
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