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

• DOI: 10.2337/dc16-0621
• Publication Date: 2016-10-18T20:14:11Z
• Authors: Ofri Mosenzon; Gil Leibowitz; Deepak L. Bhatt; Avivit Cahn; Boaz Hirshberg; Cheryl Wei; KyungAh Im; Aliza Rozenberg; Ilan Yanuv; Christina Stahre; Kausik K. Ray; Nayyar Iqbal; Eugene Braunwald; Benjamin M. Scirica; Itamar Raz
• Keywords: Saxagliptin; TIMI

Dipeptidyl peptidase 4 inhibitors may have a protective effect in diabetic nephropathy.We studied renal outcomes of 16,492 patients with type 2 diabetes, randomized to saxagliptin versus placebo and followed for median 2.1 years the Saxagliptin Assessment Vascular Outcomes Recorded Patients Diabetes Mellitus-Thrombolysis Myocardial Infarction 53 (SAVOR-TIMI 53) trial.At baseline, 9,696 (58.8%) subjects had normoalbuminuria (albumin/creatinine ratio [ACR] <30 mg/g), 4,426 (26.8%) microalbuminuria (ACR 30-300 1,638 (9.9%) macroalbuminuria >300 mg/g). Treatment was associated improvement and/or less deterioration ACR categories from baseline end trial (EOT) (P = 0.021, P < 0.001, 0.049 individuals normoalbuminuria, microalbuminuria, macroalbuminuria, respectively). At years, difference mean change between arms -19.3 mg/g 0.033) estimated glomerular filtration rate (eGFR) >50 mL/min/body surface area per 1.73 m2 (BSA), -105 0.011) 50 ≥ eGFR 30 mL/min/BSA, -245.2 0.086) mL/min/BSA. Analyzing as continuous variable showed reduction (1 year, 0.0001; 0.0143; EOT, 0.0158). The did not correlate that HbA1c (r 0.041, 0.052, 0.036; 1 similar groups. Safety outcomes, including doubling serum creatinine, initiation chronic dialysis, transplantation, or creatinine >6.0 mg/dL, were well.Treatment improved ACR, even normoalbuminuric range, without affecting eGFR. beneficial on albuminuria could be explained by its glycemic control.