Table 3.
Results of randomized controlled trials investigating dapagliflozin in terms of cardiovascular outcomes of interest
| Trial name | DECLARE‐TIMI 58 | DAPA‐HF | DAPA‐CKD | DELIVER |
|---|---|---|---|---|
| Number of participants | 17 190 | 4744 | 4304 | 6263 |
| Intervention | Dapagliflozin | Dapagliflozin | Dapagliflozin | Dapagliflozin |
| Dosing (once daily) | 10 mg | 10 mg or 5 mg | 10 mg | 10 mg |
| Mean age (years) | 64 | 66 | 62 | 72 |
| Median follow‐up (months or years) | 4.2 years | 18.2 months | 2.4 years | 2.3 years |
| Baseline HbA1c (%) | 6.5 − 12.0 | 8.3 | 6.5 | 6.6 |
| Baseline eGFR (mL/min/1.732) | >60 | ≥30 | 25–75 | 61 |
| Mean LVEF (%) | <45 | ≤40 | N/A | >40 |
| Cardiovascular effects: MACE/HHF | 3‐MACE: HR 0.83 (95% CI: 0.73–0.95; P = 0.005) | CV death, hospitalization for HF, or urgent HF visit: HR 0.75 (95% CI: 0.65–0.86, P < 0.0001) | Risk of the primary endpoint (sustained ≥50% eGFR decline, ESKD) in patients with HF: HR 0.58 (95% CI: 0.37–0.91) | Composite of worsening HF or CV death: HR 0.82 (95% CI: 0.73–0.92, P < 0.001) |
CI, confidence interval; CV, cardiovascular; DAPA‐CKD, Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease; DAPA‐HF, Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure; DECLARE‐TIMI 58, Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events; DELIVER, Dapagliflozin Evaluation to Improve the LIVEs of Patients with Preserved Ejection Fraction Heart Failure; DM, diabetes mellitus; ESKD, end‐stage kidney disease; HF, heart failure; HR, hazard ratio; MACE, major adverse cardiac events; N/A, not available.