Empagliflozin (5) – Jardiance®

• Clinical trials
  • The EMPA-KIDNEY trial is a placebo-controlled, double-blind RCT of empagliflozin in patients with CKD at risk of disease progression and an estimated glomerular filtration rate (eGFR) of ≥ 20 to < 45 ml/min/1.73 m² or an eGFR of ≥ 45 to < 90 ml/min/1.73 m² and a urinary albumin-to-creatinine ratio (UACR) of ≥ 200 mg/g.
  • The three studies – EMPA-REG OUTCOME, EMPEROR-Reduced and EMPEROR-Preserved – are placebo-controlled RCTs of empagliflozin that have already been conducted in the therapeutic indications of type 2 diabetes mellitus (EMPA-REG OUTCOME), symptomatic chronic heart failure with reduced ejection fraction (EMPEROR-Reduced) and symptomatic chronic heart failure with preserved ejection fraction (EMPEROR-Preserved).

Adults with chronic kidney disease

• An additional benefit is not proven.
• As the EMPA-KIDNEY study and the patient populations of the EMPA-REG OUTCOME, EMPEROR-Reduced and EMPEROR-Preserved do not provide any data in comparison with the currently defined appropriate comparator therapy, the studies cannot be used to derive the additional benefit of empagliflozin.
• This is a consequence resulting from the rapid shift in the therapeutic paradigm following the establishment of SGLT2 inhibitors in this therapeutic indication, and it justifies the conclusion in the present procedure that “additional benefit is not proven”.

Courtesy translation only, please refer to the German original.