Table 6.
Summary of CVOT data for SGLT-2 inhibitors currently marketed in the United States
Agent | Trial Name (clinicaltrials.gov Identifier) | Summary of Key Findings |
---|---|---|
Empagliflozin98,99 | EMPA-REG Outcome Trial (NCT01131676) | The primary composite CV outcome occurred in significantly fewer patients in the empagliflozin group (10.5%) than the placebo group (12.1%; HR, 0.86; 95% CI, 0.74 to 0.99; P=0.04 for superiority) |
The empagliflozin group had significantly lower rates of death from CV causes (3.7% versus 5.9% in the placebo group; 38% relative risk reduction), hospitalization for heart failure (2.7% and 4.1%, respectively; 35% relative risk reduction), and death from any cause (5.7% and 8.3%, respectively; 32% relative risk reduction) | ||
Doubling of SCr occurred in 1.5% of the empagliflozin group and 2.6% of the placebo group (44% relative risk reduction) | ||
Progression to macroalbuminuria occurred in 11.2% of the empagliflozin group and 16.2% of the placebo group (38% relative risk reduction) | ||
RRT was initiated in 0.3% of the empagliflozin group and 0.6% of the placebo group (55% relative risk reduction) | ||
Canagliflozin100 | CANVAS (NCT01032629) | Trial completed in February 2017; results pending |
Dapagliflozin101 | DECLARE-TIMI-58 (NCT01730534) | Trial in progress; estimated completion in April of 2019 |
SCr, serum creatinine; CANVAS, Canagliflozin Cardiovascular Assessment Study; DECLARE-TIMI-58, Dapagliflozin Effect on Cardiovascular Events.