Back to Search Start Over

Effect of Saxagliptin on Renal Outcomes in the SAVOR-TIMI 53 Trial.

Authors :
Mosenzon, Ofri
Leibowitz, Gil
Bhatt, Deepak L.
Cahn, Avivit
Hirshberg, Boaz
Wei, Cheryl
KyungAh Im
Rozenberg, Aliza
Yanuv, Ilan
Stahre, Christina
Ray, Kausik K.
Iqbal, Nayyar
Braunwald, Eugene
Scirica, Benjamin M.
Raz, Itamar
Im, KyungAh
Source :
Diabetes Care; Jan2017, Vol. 40 Issue 1, p69-76, 8p, 2 Charts, 2 Graphs
Publication Year :
2017

Abstract

<bold>Objective: </bold>Dipeptidyl peptidase 4 inhibitors may have a protective effect in diabetic nephropathy.<bold>Research Design and Methods: </bold>We 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.<bold>Results: </bold>At baseline, 9,696 (58.8%) subjects had normoalbuminuria (albumin/creatinine ratio [ACR] <30 mg/g), 4,426 (26.8%) had microalbuminuria (ACR 30-300 mg/g), and 1,638 (9.9%) had macroalbuminuria (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 -19.3 mg/g (P = 0.033) for estimated glomerular filtration rate (eGFR) >50 mL/min/body surface area per 1.73 m2 (BSA), -105 mg/g (P = 0.011) for 50 ≥ eGFR ≥ 30 mL/min/BSA, and -245.2 mg/g (P = 0.086) for eGFR <30 mL/min/BSA. Analyzing ACR as a continuous variable showed reduction in ACR with saxagliptin (1 year, P < 0.0001; 2 years, P = 0.0143; and EOT, P = 0.0158). The change in ACR did not correlate with that in HbA1c (r = 0.041, 0.052, and 0.036; 1 year, 2 years, and EOT, respectively). The change in eGFR was similar in the saxagliptin and placebo groups. Safety renal outcomes, including doubling of serum creatinine, initiation of chronic dialysis, renal transplantation, or serum creatinine >6.0 mg/dL, were similar as well.<bold>Conclusions: </bold>Treatment 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. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
01495992
Volume :
40
Issue :
1
Database :
Complementary Index
Journal :
Diabetes Care
Publication Type :
Academic Journal
Accession number :
120317926
Full Text :
https://doi.org/10.2337/dc16-0621