Table 2.

Summary of large clinical trials of the SGLT2-inhibitor class

Study title	Study type	Number of patients enrolled	Follow-up duration (years)	Study population (key inclusion criteria)	Primary outcome	Key secondary outcomes
EMPA-REG OUTCOME59	RCT 1:1:1 Empagliflozin 10 mg vs empagliflozin 25 mg vs placebo	7028	3.1	Patients with: Type 2 diabetes mellitus Established CV disease Body mass index ≤45 kg/m2 Glomerular filtration rate (GFR) >30	Reduction in CV death, non-fatal myocardial infraction or stroke in empagliflozin group vs placebo (HR 0.86, 95% CI 0.74 to 0.99)	All-cause mortality lower in empagliflozin vs placebo: p<0.01 HF hospitalisation lower in empagliflozin group vs placebo (HR 0.65, 95% CI 0.50 to 0.85) HF hospitalisation and CV death (excluding fatal stroke) lower in empagliflozin group vs placebo (HR 0.66, 95% CI 0.55 to 0.79)
CANVAS trial60	RCT 1:1:1 Canagliflozin 300 mg vs canagliflozin 100 mg vs placebo	10 142	2.4	Patients with: Type 2 diabetes mellitus High CV risk	CV death, non-fatal myocardial infarction or stroke (HR 0.86, 95% CI 0.75 to 0.87)	Reduction in CV death and HF hospitalisation greater in patients with known heart failure (HR 0.78, 95% CI 0.67 to 0.91)
DECLARE-TIMI 5861	RCT Dapagliflozin 10 mg vs placebo	17 160	4.2	Patients with: Type 2 diabetes mellitus Established CV disease or multiple risk factors	CV death, non-fatal myocardial infarction or stroke (HR 0.93, 95% CI 0.84 to 1.03)	Reduction in CV death or HF hospitalisation in dapagliflozin vs placebo (HR 0.83, 95% CI 0.73 to 0.95) Reduction in HF hospitalisation (HR 0.73, 95% CI 0.61 to 0.88) Reduction in death due to renal or CV causes (HR 0.53, 95% CI 0.43 to 0.66)
VERTIS CV trial62	RCT 1:1:1 Ertugliflozin 5 mg vs ertugliflozin 15 mg vs placebo	8246	3.5	Patients with: Type 2 diabetes mellitus Established CV disease	CV death, non-fatal MI or stroke (HR 0.97, 95% CI 0.85 to 1.11)	Lower HF hospitalisation in ertugliflozin group vs placebo (HR 0.70, 95% CI 0.54 to 0.90)
DAPA-HF trial63	RCT Dapagliflozin 10 mg vs placebo	4744	1.5	Patients with: Symptomatic heart failure Left ventricular ejection fraction (LVEF) ≤40% 50% patients with type 2 diabetes	Reduction in CV death, urgent heart failure visit or HF hospitalisation in dapagliflozin group vs placebo (HR 0.74, 95% CI 0.65 to 0.85)	Fewer HF symptoms reported on KCCQ in dapagliflozin group vs placebo (HR 1.18, 95% CI 0.65 to 0.85) Reduction in CV death and HF hospitalisation (HR 0.75, 95% CI 0.65 to 0.85) Benefits seen in both diabetics and non-diabetics
EMPEROR-Reduced trial64	RCT 1:1 Empagliflozin 10 mg vs placebo	3730	1.5	Patients with: Chronic HF, NYHA class II/III/IV LVEF ≤40% HF hospitalisation within 12 months 50% patients with type 2 diabetes	CV death or heart failure hospitalisation, for empagliflozin vs placebo (HR 0.75, 95% CI 0.65 to 0.86)	Composite renal outcome (chronic haemodialysis, renal transplantation, profound sustained reduction in eGFR): reduced in empagliflozin group vs placebo (HR 0.50, 95% CI 0.32 to 0.77) All-cause mortality lower in empagliflozin group vs placebo (HR 0.92, 95% CI 0.77 to 1.10) Benefits seen in both diabetics and non-diabetics

CI, Confidence interval; CV, cardiovascular; HF, heart failure; HR, Hazard ratio; KCCQ, Kansas City Cardiomyopathy Questionnaire; MI, myocardial infarction; NYHA, New York Heart Association; RCT, randomised controlled trial.