Table 1. Key characteristics of cardiovascular outcome trials for SGLT2i in type 2 diabetes mellitus.
| Trials | EMPA-REG OUTCOME | CANVAS PROGRAM | DECLARE-TIMI 58 | VERTIS-CV | SCORED | |
|---|---|---|---|---|---|---|
| SGLTi | Empagliflozin 10/25 mg | Canagliflozin 100/300 mg | Dapagliflozin 10 mg | Ertugliflozin 5/15 mg | Sotagliflozin 200/400 mg | |
| Population | 7,020 | 10,142 | 17,160 | 8,246 | 10,584 | |
| Enrolled period | Sep 2010 to Apr 2013 | Dec 2009 to May 2015 | Apr 2013 to Jun 2015 | Dec 2013 to Apr 2017 | Dec 2017 to Jan 2020 | |
| Publication year | 2015 | 2017 | 2018 | 2020 | 2020 | |
| Established ASCVD (%) | 99 | 66 | 41 | 100 | 89 | |
| Follow-up (years) | 3.1 | 3.6 | 4.2 | 3.5 | 1.3 | |
| eGFR for enrollment (mL/min/1.73 m2) | ≥30 | ≥30 | ≥60 | ≥30 | 25–60 | |
| eGFR <60 (%) | 26 | 20 | 7 | 22 | 100 | |
| Heart failure history (%) | 10 | 14 | 10 | 24 | 31 | |
| Primary outcomes | MACE | MACE | MACE | MACE | CV death + HFH | |
| HR (95% CI) | 0.86 (0.74–0.99) | 0.86 (0.75–0.97) | 0.93 (0.84–1.03) | 0.97 (0.85–1.11) | 0.74 (0.63–0.88) | |
| Rate/1,000 patient-year (SGLT2i vs. placebo) | 37.4 vs. 43.9 | 26.9 vs. 31.5 | 22.6 vs. 24.2 | 39 vs. 40 | 56 vs. 75 | |
| CV death | 0.62 (0.49–0.77) | 0.87 (0.72–1.06) | 0.98 (0.82–1.17) | 0.92 (0.77–1.11) | 0.90 (0.73–1.12) | |
| All-cause mortality | 0.68 (0.57–0.82) | 0.87 (0.74–1.01) | 0.93 (0.82–1.04) | 0.93 (0.80–1.08) | 0.99 (0.83–1.18) | |
| Nonfatal MI | 0.87 (0.70–1.09) | 0.85 (0.69–1.05) | 0.89 (0.77–1.01) | 1.04 (0.86–1.27) | 0.68 (0.52–0.89)† | |
| Nonfatal stroke | 1.18 (0.89–1.56) | 0.90 (0.71–1.15) | 1.01 (0.84–1.21) | 1.00 (0.76–1.32) | 0.66 (0.48–0.91)* | |
| HFH | 0.65 (0.50–0.85) | 0.67 (0.52–0.87) | 0.73 (0.61–0.88) | 0.70 (0.54–0.90) | 0.67 (0.55–0.82) | |
| CV death/HFH | 0.66 (0.55–0.79)* | 0.78 (0.67–0.91) | 0.83 (0.73–0.95) | 0.88 (0.75–1.03) | 0.74 (0.63–0.88) | |
| Renal endpoints | 0.54 (0.40–0.75) | 0.60 (0.47–0.77) | 0.53 (0.43–0.66) | 0.81 (0.63–1.04) | 0.71 (0.46–1.08) | |
ASCVD = atherosclerotic cardiovascular disease; CI = confidence interval; CV = cardiovascular; eGFR = estimated glomerular filtration rate; HFH = heart failure hospitalization; HR = hazard ratio; MACE = major adverse cardiac events; MI = myocardial infarction; SGLT = sodium-glucose co-transporter; SGLTi = sodium-glucose co-transporter inhibitors; SGLT2i = sodium-glucose co-transporter 2 inhibitors.
*Excluding fatal stroke. †Total fatal or nonfatal MI/stroke.