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Table 3 Risk associated with study drug compared to placebo for adverse events in the Dapagliflozin Effect on CardiovascuLAR Events (DECLARE-TIMI 58), CANagliflozin CardioVascular Assessment Study (CANVAS) Program, Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients–Removing Excess Glucose (EMPA–REG OUTCOME), and Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trials

From: Class effects of SGLT2 inhibitors on cardiorenal outcomes

  DECLARE-TIMI 58 CANVAS EMPA–REG OUTCOME CREDENCE
Male genital infectiona +b +b +b +b
Female genital infectiona +b +b +
Any AE N/A N/A b b
Serious AE b b b b
AE causing discontinuation +b + b N/A
Hypoglycemia b +
UTI + +
Fracture + +b
Hyperkalemia N/A + N/A
Amputation + +b N/A +
AKI b b
Breast cancer 0 + N/A +
Bladder cancer b N/A +
DKA +b + + +b
  1. AE adverse event, N/A not available, UTI urinary tract infection, AKI acute kidney injury, DKA diabetic ketoacidosis
  2. aDECLARE-TIMI 58 did not differentiate genital infection by sex
  3. bindicates statistical significance at the α = 0.05 level. “+” = increased risk, “−” = decreased risk, “0” = no difference in risk