Table 1.

Summary of clinical trials on new antidiabetic drugs.

Trial	Molecule	Dosage	Inclusion criteria	Primary CV outcome
EMPA-REG OUTCOME	Empagliflozin vs. placebo	10 mg/day, incremental to 25 mg/day	Type II diabetes mellitus and high CV risk	Reduction in death rate from CV events [265/4687 patients (5.7%)] vs. placebo [198/2333 patients (8.5%), HR: 0.66 (95% CI: 0.55–0.79); P < 0.001]
				Reduction in death rate and hospitalization for heart failure [104/4687 patients (4.5%)] vs. placebo [129/2333 (2.8), HR: 0.61 (95 % CI: 0.47–0.79); P < 0.001]
CANVAS program	Canagliflozin vs. placebo	100 mg/day, increased to 300 mg/day if GFR>60 mL/min/1.73 m2	Poorly controlled type II diabetes mellitus with high risk of CV or previous CV events	Reduction of death rate from CV events, MI non-fatal, non-fatal stroke [reduction of 14% vs. placebo, HR: 0.86 (95% CI: 0.75–0.97)]
				33% reduction in hospitalization rate for heart failure vs. placebo [HR: 0.67 (95% CI: 0.52–0.87)]
DECLARE-TIMI 58	Dapagliflozin vs. placebo	5 mg/day, which can be increased up to 10 mg/day	Type II diabetes mellitus and high CV risk or previous CV events	Reduction in hospitalization rate for heart failure by 27% vs. placebo [HR 0.73 (95 % CI: 0.61–0.88)]
VERTIS CV	Ertugliflozin vs. placebo	5 mg/day, increased up to 15 mg/day	Type II diabetes mellitus and known CV disease	Reduction in risk of first hospitalization for heart failure vs. placebo [HR 0.70 (95% CI: 0.54–0.90); P = 0.006]
DAPA-HF	Dapagliflozin vs. placebo	10 mg/die	Heart failure with reduced FE ≤40% + elevated NT-proBNP	Reduction of primary composite outcome (death from CV events, exacerbation of heart failure requiring hospitalization or urgent visit) by 26% [386 patients with dapagliflozin (16.3%) vs. 502 (21.2%) with placebo; HR: 0.74 (95% CI: 0.65–0.85); P < 0.001]
DELIVER	Dapagliflozin vs. placebo	10 mg/die	Heart failure with preserved ejection fraction	Death from CV events, exacerbation of heart failure requiring hospitalization or urgent visit. Results not yet available
EMPEROR-Reduced	Empagliflozin vs. placebo	10 mg/die	Heart failure with reduced EF ≤40% + elevated NT-proBNP	Reduced risk of death from CV events and heart failure exacerbation requiring hospitalization compared to placebo [19.4% vs. 24.7%; HR 0.75 (95% CI: 0.65–0.86) P < 0.001]
EMPEROR-Preserved	Empagliflozin vs. placebo	10 mg/die	Heart failure with preserved ejection fraction	Death from CV events, exacerbation of heart failure with the need for hospitalization. Results not yet available

CI, confidence interval.