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2016 ; 129
(16
): 1894-903
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gab.com Text
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Efficacy of Leflunomide, Telmisartan, and Clopidogrel for Immunoglobulin A
Nephropathy: A Randomized Controlled Trial
#MMPMID27503012
Wu J
; Duan SW
; Sun XF
; Li WG
; Wang YP
; Liu WH
; Zhang JR
; Lun LD
; Li XM
; Zhou CH
; Li JJ
; Liu SW
; Xie YS
; Cai GY
; Ma L
; Huang W
; Wu H
; Jia Q
; Chen XM
Chin Med J (Engl)
2016[Aug]; 129
(16
): 1894-903
PMID27503012
show ga
BACKGROUND: The efficacy and safety of telmisartan combined with clopidogrel,
leflunomide, or both drugs for immunoglobulin A nephropathy (IgAN) are unclear.
This study was designed to evaluate the efficacy and safety of telmisartan
combined with clopidogrel, leflunomide, or both drugs for IgAN. METHODS: It is a
multicenter, prospective, double-dummy randomized controlled trial. Primary IgAN
patients were recruited in 13 renal units across Beijing, China, from July 2010
to June 2012. After a 4-week telmisartan (80 mg/d) wash-in, 400 patients
continuing on 80 mg/d telmisartan were randomly assigned to additionally receive
placebo (Group A), 50 mg/d clopidogrel (Group B), 20 mg/d leflunomide (Group C),
or 50 mg/d clopidogrel and 20 mg/d leflunomide (Group D). The 24-week
intervention was completed by 360 patients. The primary endpoint was change in
24-h proteinuria at 24 weeks. A linear mixed-effect model was used to analyze the
changes at 4, 12, and 24 weeks. Generalized estimating equations were used to
evaluate changes in hematuria grade. This trial was registered at the Chinese
Clinical Trial Registry. RESULTS: The effects of telmisartan combined with
leflunomide on changes in proteinuria (0.36 [95% confidence interval (CI)
0.18-0.55] g/d, P < 0.001), in serum uric acid (76.96 [95% CI 57.44-96.49]
?mol/L, P < 0.001), in serum creatinine (9.49 [95% CI 6.54-12.44] ?mol/L, P <
0.001), and in estimated glomerular filtration rate (-6.72 [95% CI-9.46 to -3.98]
mlˇmin-1ˇ1.73 m-2, P < 0.001) were statistically significant, whereas they were
not statistically significant on changes in systolic and diastolic blood pressure
and weight (P > 0.05). Telmisartan combined with clopidogrel had no statistical
effect on any outcome, and there was no interaction between the interventions. No
obvious adverse reactions were observed. CONCLUSIONS: Telmisartan combined with
leflunomide, not clopidogrel, is safe and effective for decreasing proteinuria in
certain IgAN patients. TRIAL REGISTRATION: chictr.org.cn, ChiCTR-TRC-10000776;
http://www.chictr.org.cn/showproj.aspx?proj=8760.
|Adolescent
[MESH]
|Adult
[MESH]
|Benzimidazoles/adverse effects/*therapeutic use
[MESH]
|Benzoates/adverse effects/*therapeutic use
[MESH]