Reversibility of fenofibrate therapy-induced renal function impairment in ACCORD type 2 diabetic participants.
Reversibility of fenofibrate therapy-induced renal function impairment in ACCORD type 2 diabetic participants.
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ACCORD 2 型糖尿病参与者非诺贝特治疗引起的肾功能损害的可逆性。
DOI：
10.2337/dc11-1811
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发表时间：
2012-05
期刊：
影响因子：
16.2
通讯作者：
Ginsberg HN
中科院分区：
文献类型：
--
作者：
Mychaleckyj JC;Craven T;Nayak U;Buse J;Crouse JR;Elam M;Kirchner K;Lorber D;Marcovina S;Sivitz W;Sperl-Hillen J;Bonds DE;Ginsberg HN
评估糖尿病患者连续接受非诺贝特治疗5年后血清肌酐水平升高的可逆性。控制糖尿病心血管风险措施（雅阁）血脂试验的一项在药/停药辅助研究，旨在研究血清肌酐和胱抑素C的试验后变化。基于回顾性试验期间血清肌酐水平，招募合格受试者参加前瞻性、巢式、三组研究：非诺贝特病例受试者（n = 321，治疗3个月后升高≥20%）;非诺贝特对照受试者（n = 175，升高≤2%）;安慰剂对照受试者（n = 565）。在试验结束时和停止试验治疗后6-8周测量血清肌酐和胱抑素C。试验结束时，病例受试者的校正血清肌酐（± SE）mg/dL最高（1.11 ± 0.02）和最低校正估计肾小球滤过率（eGFR）（± SE）mL/min/1.73 m2（68.4 ± 1.0）与对照组受试者（1.01 ± 0.02; 74.8 ± 1.3）和安慰剂组受试者（0.98 ± 0.01; 77.8 ± 0.7）。停药51天后，病例受试者的血清肌酐仍高于（0.97 ± 0.02），eGFR仍低于（77.8 ± 1.0）对照受试者（0.90 ± 0.02; 81.8 ± 1.3），但与安慰剂受试者（0.99 ± 0.01; 76.6 ± 0.7）无差异。血清半胱氨酸蛋白酶抑制剂C的变化概括了血清肌酐的变化。试验期间血清肌酐初始显著升高（≥20%）的受试者的肾功能恢复至与接受安慰剂的受试者相同的水平，而血清肌酐升高≤2%的受试者与相同的安慰剂对照组相比，肾功能净保留。非诺贝特相关的试验期间血清肌酐升高是可逆的，停药51天后完全逆转。半胱氨酸蛋白酶抑制剂C结果的相似性表明，这种变化的机制不是血清肌酐特异性的。
To assess the reversibility of the elevation of serum creatinine levels in patients with diabetes after 5 years of continuous on-trial fenofibrate therapy. An on-drug/off-drug ancillary study to the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid Trial to investigate posttrial changes in serum creatinine and cystatin C. Eligible participants were recruited into a prospective, nested, three-group study based on retrospective on-trial serum creatinine levels: fenofibrate case subjects (n = 321, ≥20% increase after 3 months of therapy); fenofibrate control subjects (n = 175, ≤2% increase); and placebo control subjects (n = 565). Serum creatinine and cystatin C were measured at trial end and 6–8 weeks after discontinuation of trial therapy. At trial end, case subjects had the highest adjusted serum creatinine (± SE) mg/dL (1.11 ± 0.02) and the lowest adjusted estimated glomerular filtration rate (eGFR) (± SE) mL/min/1.73 m2 (68.4 ± 1.0) versus control subjects (1.01 ± 0.02; 74.8 ± 1.3) and placebo subjects (0.98 ± 0.01; 77.8 ± 0.7). After 51 days off-drug, serum creatinine in case subjects was still higher (0.97 ± 0.02) and eGFR still lower (77.8 ± 1.0) than control subjects (0.90 ± 0.02; 81.8 ± 1.3) but not different from placebo subjects (0.99 ± 0.01; 76.6 ± 0.7). Changes in serum cystatin C recapitulated the serum creatinine changes. Participants with significant initial on-trial increases in serum creatinine (≥20%) returned to the same level of renal function as participants receiving placebo while participants who had ≤2% increase in serum creatinine had net preservation of renal function compared with the same unselected placebo reference group. The fenofibrate-associated on-trial increases in serum creatinine were reversible, and the reversal was complete after 51 days off-drug. The similarity of the cystatin C results suggests that the mechanism of this change is not specific for serum creatinine.
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影响因子：
16.2
作者：
Forsblom C;Hiukka A;Leinonen ES;Sundvall J;Groop PH;Taskinen MR
通讯作者：
Taskinen MR
影响因子：
6.1
作者：
Broeders, N;Knoop, C;Abramowicz, D
通讯作者：
Abramowicz, D
DOI：
10.1056/nejmoa1001282
发表时间：
2010-04-29
期刊：
The New England journal of medicine
影响因子：
--
作者：
ACCORD Study Group;Ginsberg HN;Elam MB;Lovato LC;Crouse JR 3rd;Leiter LA;Linz P;Friedewald WT;Buse JB;Gerstein HC;Probstfield J;Grimm RH;Ismail-Beigi F;Bigger JT;Goff DC Jr;Cushman WC;Simons-Morton DG;Byington RP
通讯作者：
Byington RP
影响因子：
13.2
作者：
Stevens, Lesley A.;Coresh, Josef;Levey, Andrew S.
通讯作者：
Levey, Andrew S.
影响因子：
13.2
作者：
Ansquer, JC;Foucher, C;Steiner, G
通讯作者：
Steiner, G