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Table 1 Overview of SGLT2 inhibitor CVOTs

From: SGLT2 inhibitors in T2D and associated comorbidities — differentiating within the class

Study Trial # Completion Primary outcome(s) Main reported secondary CV and renal outcomes
EMPA-REG OUTCOME (empagliflozin) [16, 33] NCT01131676 Completed 2015; results published Time to first occurrence of 3P-MACE 4P-MACE; CV death; death by any cause; symptomatic MI; symptomatic non-fatal MI; silent MI; hospitalisation for unstable angina; coronary revascularisation procedure; stroke; non-fatal stroke; TIA; HHF; HHF or CV death excluding stroke; incident or worsening nephropathy or CV death; incident or worsening nephropathy; progression to macroalbuminuria; dSCr and eGFR ≤45 ml/min/1.73m2; initiation of RRT; dSCr and eGFR ≤45 ml/min/1.73m2, initiation of RRT or renal death; incident albuminuria in patients with normal albumin at baseline
CANVAS Program (canagliflozin) [17, 34] NCT01032629 (CANVAS) & NCT01989754 (CANVAS-R) Completed 2017; results published Time to first occurrence of 3P-MACE Death by any cause; CV death; progression of albuminuria; CV death or HHF; non-fatal MI; non-fatal stroke; MI; stroke; hospitalisation for any cause; HHF; new-onset albuminuria; new-onset microalbuminuria; new-onset macroalbuminuria; dSCr, ESRD or renal death; dSCr, ESRD, renal death or new-onset macroalbuminuria; dSCr, ESRD, renal death or CV death; ≥40% decrease in eGFR, ESRD or renal death; ≥40% decrease in eGFR, ESRD, renal death or new-onset macroalbuminuria; ≥40% decrease in eGFR, ESRD, renal death or CV death; 40% reduction in eGFR; dSCr; ESRD; ESRD or renal death
DECLARE-TIMI 58 (dapagliflozin) [18] NCT01730534 Completed 2018; results published Time to first occurrence of 3P-MACE Time to first occurrence of CV death or HHF ≥40% decrease in eGFR to eGFR < 60 ml/min/1.73m2, ESRD, renal death or CV death; death by any cause; ≥40% decrease in eGFR to eGFR < 60 ml/min/1.73m2, ESRD or renal death; HHF; MI; ischaemic stroke; CV death; non-CV death
VERTIS-CV (ertugliflozin) [35] NCT01986881 Estimated completion 2019 Time to first occurrence of 3P-MACE Results not yet reported
  1. Definitions differed between trials. 3P-MACE is a composite of CV death, MI and stroke. 4P-MACE is a composite of CV death, MI, stroke and hospitalisation for unstable angina. Study names: EMPA-REG OUTCOME [cardiovascular outcomes trial of empagliflozin]; CANVAS, Canagliflozin Cardiovascular Assessment Study; CANVAS-R, Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM; DECLARE-TIMI, Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events; VERTIS-CV Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Cardiovascular Outcomes Following Treatment With Ertugliflozin (MK-8835/PF-04971729) in Subjects With Type 2 Diabetes Mellitus and Established Vascular Disease. 3/4P-MACE, 3/4-point major adverse CV event; CV, cardiovascular; dSCr, doubling of serum creatinine; eGFR, estimated glomerular filtration rate; ESRD, end-stage renal disease; HHF, hospitalisation for heart failure; MI, myocardial infarction; RRT, renal replacement therapy; TIA, transient ischaemic attack