JARDIANCE® (Empagliflozin)

Efficacy

EMPA-KIDNEY is the only SGLT2i CKD trial to include the understudied type of patients with low eGFR and without albuminuria^1,5

The EMPA-KIDNEY trials is a randomised, double-blind trial to evaluate efficacy and safety of once-daily JARDIANCE 10mg (n=3304) compared to placebo (n=3305), in adults with or without T2D with evidence of CKD at risk of progression. Median follow up was 2 years.

JARIDANCE reduced risk of kidney disease progression or CV death in a broad patient population* vs placebo¹

* EMPA-KIDNEY included patients with a wide range of underlying causes of CKD, many with co-morbidities across the spectrum of cardiovascular, kidney, or metabolic conditions. EMPA-KIDNEY included adult patients with an eGFR ≥20 to <45mL/min/1.73m² or an eGFR ≥45 to <90mL/min/1.73m² with a UACR ≥200mg/g, at risk of CKD progression.

Kidney disease progression defined as: adults with kidney function loss (sustained reduction of ≥40% eGFR decline, sustained eGFR <10mL/min/1.73m²), end stage kidney disease (initiation of chronic dialysis or kidney transplant), or renal death.

Protect the kidneys and heart of your CKD patients¹

JARDIANCE demonstrated consistent results in the subgroup analysis of the primary end point across a range of baseline characteristics^1,3*

† History of diabetes was defined as a patient-reported history of diabetes of any type, use of glucose-lowering medication, or a glycated haemoglobin level of at least 48mmol/mol (6.5%) at the randomisation visit. Of the diabetic patients enrolled (both T1D and T2D), >95% had T2D.¹

‡ Values represent the measurement recorded at the randomisation visit or the most recent local laboratory result recorded before randomisation.

* Results of subgroup analyses of underlying cause of renal diseases, (Diabetic kidney disease; Hypertensive/renovascular disease; Glomerular disease; Other/unknown), baseline diabetes, baseline eGFR and RAASI use were consistent (interaction p-values >0.05).

JARDIANCE protected the kidneys by slowing the decline of renal function over time and could delay time to dialysis¹

Enrolled patients down to an eGFR of 20mL/min/1.73m²

Prespecified tertiary outcome of EMPA-KIDNEY trial

* Prespecified tertiary outcome: (Chronic slope, referred to as “Long term”): Mean annual rates of change in eGFR from 2 months to the final follow-up visit by treatment allocation were estimated using shared parameter models.

Annual rate of change in eGFR¹

Mean eGFR decline per year (total slope)^†

Prespecified tertiary outcome of EMPA-KIDNEY trial

^† Prespecified tertiary outcome included the mean annual rates of change in eGFR in mL/min/1.73m² per year from baseline to the final follow-up visit (“total slopes”) by treatment allocation were estimated using shared parameter models.

JARDIANCE slowed progression of kidney function decline after the known initial dip in eGFR^1,2,4

Change from baseline in eGFR^*

Prespecified exploratory outcome of EMPA-KIDNEY trial

* Prespecified exploratory outcome. Linear mixed models for repeated measures analyses were used to estimate the mean estimated eGFR in each group at each scheduled follow-up visit.