Effect of Saxagliptin on Renal Outcomes in the SAVOR-TIMI 53 Trial
Effect of Saxagliptin on Renal Outcomes in the SAVOR-TIMI 53 Trial
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DOI：
10.2337/dc16-0621
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发表时间：
2017-01-01
期刊：
影响因子：
16.2
通讯作者：
Raz, Itamar
中科院分区：
文献类型：
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作者：
Mosenzon, Ofri;Leibowitz, Gil;Raz, Itamar
目的探讨二肽基肽酶4抑制剂对糖尿病肾病的保护作用。研究设计和方法：我们研究了16492例2型糖尿病患者的肾脏结局，随机分为沙格列汀组和安慰剂组，并在沙格列汀评估糖尿病-心肌梗死溶栓患者血管结局53 （SAVOR-TIMI 53）试验中进行了中位随访2.1年。结果基线时，9696例（58.8%）受试者尿白蛋白正常（白蛋白/肌酐比值[ACR] 300 mg/g）。从基线到试验结束（EOT），沙格列汀治疗与ACR类别的改善和/或较少恶化相关（P = 0.021, P < 0.001和P = 0.049，分别适用于基线正常蛋白尿、微量蛋白尿和大量蛋白尿的个体）。2年后，沙格列汀组和安慰剂组的平均ACR变化差异为肾小球滤过率（eGFR）估计为219.3 mg/g (P = 0.033)，每1.73 m(2) （BSA）估计为50ml /min/体表面积，50> = eGFR >= 30ml /min/BSA为2105 mg/g (P = 0.011), eGFR 6.0 mg/dL估计为2245.2 mg/g （P = 0.086）。结论沙格列汀治疗可改善ACR，即使在正常蛋白尿范围内，但不影响eGFR。沙格列汀对蛋白尿的有益作用不能用它对血糖控制的作用来解释。
OBJECTIVEDipeptidyl peptidase 4 inhibitors may have a protective effect in diabetic nephropathy.RESEARCH DESIGN AND METHODSWe studied renal outcomes of 16,492 patients with type 2 diabetes, randomized to saxagliptin versus placebo and followed for a median of 2.1 years in the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus-Thrombolysis in Myocardial Infarction 53 (SAVOR-TIMI 53) trial.RESULTSAt baseline, 9,696 (58.8%) subjects had normoalbuminuria (albumin/creatinine ratio [ACR] 300 mg/g). Treatment with saxagliptin was associated with improvement in and/or less deterioration in ACR categories from baseline to end of trial (EOT) (P = 0.021, P < 0.001, and P = 0.049 for individuals with baseline normoalbuminuria, microalbuminuria, and macroalbuminuria, respectively). At 2 years, the difference in mean ACR change between saxagliptin and placebo arms was 219.3 mg/g (P = 0.033) for estimated glomerular filtration rate (eGFR) >50 mL/min/body surface area per 1.73 m(2) (BSA), 2105 mg/g (P = 0.011) for 50 >= eGFR >= 30 mL/min/BSA, and 2245.2 mg/g (P = 0.086) for eGFR 6.0 mg/dL, were similar as well.CONCLUSIONSTreatment with saxagliptin improved ACR, even in the normoalbuminuric range, without affecting eGFR. The beneficial effect of saxagliptin on albuminuria could not be explained by its effect on glycemic control.