Journal
DIABETES CARE
Volume 38, Issue 4, Pages 696-705Publisher
AMER DIABETES ASSOC
DOI: 10.2337/dc14-1850
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Categories
Funding
- AstraZeneca/Bristol-Myers Squibb
- AstraZeneca
- Bristol-Myers Squibb
- Amarin
- Eisai
- Ethicon
- Medtronic
- Roche
- Sanofi
- Medicines Company
- TIMI Study Group
- Merck Sharp Dohme
- Hadassah Hebrew University Hospital from AstraZeneca
- Eli Lilly
- Novartis
- Novo Nordisk
- Bayer
- Pfizer
- Daiichi-Sankyo
- Servier
- Vivus
- Janssen
- Johnson Johnson
- President of WorldWIDE Diabetes
- Executive Committee CME of The University of Texas Southwestern Medical Center
- editorial boards of The Journal of Diabetes and ALAD
- Journal of the Latin American Diabetes Association
- Heart Institute (InCor) at the University of Sao Paulo Medical School from AstraZeneca
- Brigham and Women's Hospital
- Boehringer Ingelheim
- Janssen Research and Development LLC
- Duke Clinical Research Institute
- Cleveland Clinic Coordinating Center for Clinical Research
- University of Oxford
- Eli Lilly USA
- F. Hoffmann-La Roche
- GlaxoSmithKline
- Takeda Pharmaceuticals North America
- Omthera
- Regeneron
- Gilead Sciences
- Takeda
- Keenan Research Centre in the Li Ka Shing Knowledge Institute of St. Michael's Hospital
- University of Toronto, from AstraZeneca
- Brigham and Women's Hospital from AstraZeneca
- Bayer Healthcare
- Gilead
- Lexicon
- Arena
- St. Jude's Medical
- Forest Pharmaceuticals
- Boston Clinical Research Institute
- Decision Resources
- University of Calgary
- Elsevier Practice Update Cardiology
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OBJECTIVEThe glycemic management of patients with type 2 diabetes mellitus (T2DM) and renal impairment is challenging, with few treatment options. We investigated the effect of saxagliptin in the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR)-Thrombolysis in Myocardial Infarction (TIMI) 53 trial according to baseline renal function.RESEARCH DESIGN AND METHODSPatients with T2DM at risk for cardiovascular events were stratified as having normal or mildly impaired renal function (estimated glomerular filtration rate [eGFR] >50 mL/min/1.73 m(2); n = 13,916), moderate renal impairment (eGFR 30-50 mL/min/1.73 m(2); n = 2,240), or severe renal impairment (eGFR <30 mL/min/1.73 m(2); n = 336) and randomized to receive saxagliptin or placebo. The primary end point was cardiovascular death, myocardial infarction, or ischemic stroke.RESULTSAfter a median duration of 2 years, saxagliptin neither increased nor decreased the risk of the primary and secondary composite end points compared with placebo, irrespective of renal function (all P for interactions 0.19). Overall, the risk of hospitalization for heart failure among the three eGFR groups of patients was 2.2% (referent), 7.4% (adjusted hazard ratio [HR] 2.38 [95% CI 1.95-2.91], P < 0.001), and 13.0% (adjusted HR 4.59 [95% CI 3.28-6.28], P < 0.001), respectively. The relative risk of hospitalization for heart failure with saxagliptin was similar (P for interaction = 0.43) in patients with eGFR >50 mL/min/1.73 m(2) (HR 1.23 [95% CI 0.99-1.55]), eGFR 30-50 mL/min/1.73 m(2) (HR 1.46 [95% CI 1.07-2.00]), and in patients with eGFR <30 (HR 0.94 [95% CI 0.52-1.71]). Patients with renal impairment achieved reductions in microalbuminuria with saxagliptin (P = 0.041) that were similar to those of the overall trial population.CONCLUSIONSSaxagliptin did not affect the risk of ischemic cardiovascular events, increased the risk of heart failure hospitalization, and reduced progressive albuminuria, irrespective of baseline renal function.
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