JARDIANCE® (Empagliflozin)

^† EMPA-REG Outcome Trial: A randomised, double-blind, placebo-controlled cardiovascular outcomes trial (n=7020). Patients with T2D and CVD were randomised to receive JARDIANCE (10mg or 25mg) (n=4687) or placebo (n= 2333) once daily, on top of standard of care. Patients were adults with insufficiently controlled T2D and CAD, PAD, or a history of MI or stroke. Primary endpoint for JARDIANCE (pooled figures for 10mg and 25mg dose vs placebo): 3-point MACE (time to first occurrence of CV death, non-fatal myocardial infarction or non-fatal stroke), 14% RRR (1.6% ARR) HR 0.86, 95% CI 0.74–0.99, p=0.04 for superiority. Pre-defined exploratory endpoint for JARDIANCE (pooled figures for 10mg and 25mg dose vs placebo): CV death 38% RRR (2.2% ARR) (HR 0.62, 95% CI 0.49–0.77, p<0.001).²

^‡ EMPEROR-Reduced Trial: Phase III randomised, double-blind trial to evaluate efficacy and safety of once-daily JARDIANCE 10mg (n=1863) compared to placebo (n=1867). Patients were adults with chronic heart failure (NYHA class II, III, or IV) and reduced ejection fraction (LVEF ≤40%). JARDIANCE achieved primary composite endpoint vs placebo: adjudicated CV death or HHF, analysed as time to the first event (RRR-25%, ARR-5.2%).³

^# EMPEROR-Preserved Trial: Phase III randomised, double-blind trial to evaluate efficacy and safety of once-daily JARDIANCE 10mg (n=2997) compared to placebo (n=2991). Patients were adults with chronic heart failure (NYHA class II, III, or IV) and preserved ejection fraction (LVEF >40%). JARDIANCE achieved primary composite endpoint vs placebo: adjudicated CV death or HHF, analysed as time to the first event (RRR-21%, ARR-3.3%).⁴

* EMPA-KIDNEY Trial: The trial enrolled 6,609 patients who had evidence of CKD at risk of kidney disease progression, with and without diabetes, with and without albuminuria. Patients with an eGFR ≥20 to <45 mL/min/1.73m2, or an eGFR ≥45 to <90 mL/ min/1.73m2 with a UACR ≥200mg/g, were randomised to receive either 10mg empagliflozin (n=3304) or placebo (n=3305) on top of standard of care. JARDIANCE achieved primary endpoint vs placebo: risk reduction in kidney disease progression or CV death 28% RRR/3.6% ARR (HR=0.72; 95% CI: 0.64, 0.82; p<0.001). Kidney disease progression was defined as end-stage kidney disease (ESKD: the initiation of maintenance dialysis or receipt of a kidney transplant), a sustained decrease in the eGFR to <10 mL/min/1.73m2 , a sustained decrease from baseline in the eGFR of at least 40%, or death from renal causes.^5,6