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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