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
| 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 |
AE adverse event, N/A not available, UTI urinary tract infection, AKI acute kidney injury, DKA diabetic ketoacidosis
aDECLARE-TIMI 58 did not differentiate genital infection by sex
bindicates statistical significance at the α = 0.05 level. “+” = increased risk, “−” = decreased risk, “0” = no difference in risk