Table 1.
Cardiovascular safety studies with empagliflozin, dapagliflozin and canagliflozin in patients with type 2 diabetes mellitus
| Parameter | EMPA-REG OUTCOME1 | DECLARE-TIMI 5814 | CANVAS8,15 | CANVAS-R16 |
|---|---|---|---|---|
| Drug | Empagliflozin | Dapagliflozin | Canagliflozin | Canagliflozin |
| n | 7020 | 17276 | 4327 | 5826 |
| Primary end point | CV death, non-fatal MI or non-fatal stroke | CV death, non-fatal MI or ischemic stroke | CV death, non-fatal MI or non-fatal stroke | Progression of albuminuria |
| Main inclusion criteria | Established CV disease, HbA1c ≥7.0% and <9% (patients without previous hypoglycemic treatment) or <10% (patients with previous hypoglycemic treatment) | High risk for CV disease | CV disease or high CV risk, HbA1c ≥7.0% and ≤10.5% | CV disease or high CV risk, HbA1c ≥7.0% and ≤10.5% |
| Study population | ||||
| Age (years) | 63.1 | 62.4 | ||
| HbA1c (%) | 8.1 | 8.2 | ||
| CV disease (%) | 99.4 | 62.7 | ||
| End of study | April 2015 | April 2019 | April 2017 | January 2017 |
Note: Data from the CANVAS study are combined with data from the CANVAS-R study for a pre-specified cardiovascular safety meta-analysis.
Abbreviations: CV, cardiovascular; MI, myocardial infarction; HbA1c, glycated hemoglobin.