![]() ![]() 3 The extent of increased glucosuria, and therefore the glucose-lowering efficacy of an SGLT2i, is attenuated in patients with worse kidney function, as reflected by a lower estimated GFR (eGFR). Sodium-glucose cotransporter 2 inhibitor (SGLT2i) therapy, which promotes urinary glucose excretion, decreases the risk for CV death and hospitalization for heart failure (HHF) among patients with type 2 diabetes. 1, 2 Patients with both type 2 diabetes and kidney dysfunction, a frequent comorbidity, therefore represent a particularly vulnerable patient population. Kidney dysfunction, including both reduced glomerular filtration rate (GFR) and albuminuria, is associated with increased risk for cardiovascular (CV) outcomes. DECLARE TIMI 58 REGISTRATIONTrial Registration Identifier: NCT01730534 The numbers of amputations, cases of diabetic ketoacidosis, fractures, and major hypoglycemic events were balanced or numerically lower with dapagliflozin compared with placebo for patients with an eGFR below 60 mL/min/1.73 m 2 and an UACR of 30 mg/g or higher.Ĭonclusions and Relevance The effect of dapagliflozin on the relative risk for CV events was consistent across eGFR and UACR groups, with the greatest absolute benefit for the composite of CV death or HHF observed among patients with both reduced eGFR and albuminuria. The absolute risk difference for the composite of CV death or HHF was greater for patients with more markers of CKD (0 markers, −0.5% 1 marker, −1.0% and 2 markers, −8.3% P = .02 for interaction). Patients were categorized according to prespecified subgroups of baseline eGFR ( .24 for interaction), although greater absolute risk reductions were observed with more markers of CKD. Objective To assess the CV efficacy and safety of dapagliflozin according to baseline estimated glomerular filtration rate (eGFR) and urinary albumin to creatinine ratio (UACR).ĭesign, Setting, and Participants This secondary analysis of the randomized clinical trial Dapagliflozin Effect on Cardiovascular Events–Thrombolysis in Myocardial Infarction 58 compared dapagliflozin vs placebo in 17 160 patients with type 2 diabetes and a baseline creatinine clearance of 60 mL/min or higher. The relative CV efficacy and safety of dapagliflozin according to baseline kidney function and albuminuria status are unknown. Importance Sodium-glucose cotransporter 2 inhibitors, such as dapagliflozin, promote renal glucose excretion and reduce cardiovascular (CV) deaths and hospitalizations for heart failure (HHF) among patients with type 2 diabetes. Meaning In this study, the effect of dapagliflozin on the relative risk for CV events was consistent across kidney function and albuminuria status, with the greatest absolute benefit for the composite of CV death or HHF observed among patients with both reduced estimated glomerular filtration rate and albuminuria. However, the absolute risk reduction of CV death and HHF was significantly larger for dapagliflozin-treated patients who had more markers of chronic kidney disease. Question What is the relative cardiovascular (CV) efficacy and safety of dapagliflozin according to the baseline estimated glomerular filtration rate and urinary albumin to creatinine ratio in patients with type 2 diabetes?įindings In this secondary analysis of 17 160 participants included in the DECLARE-TIMI 58 trial, the effect of dapagliflozin (vs placebo) on the relative risk of a composite of CV death and hospitalization for heart failure (HHF) and of major adverse cardiovascular events was similar.
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