Results from the EMPA-KIDNEY trial, published in the New England Journal of Medicine, demonstrate that the SGLT2 inhibitor empagliflozin reduces the risk of renal disease progression or cardiovascular death in a wide range of people with chronic kidney disease (CKD), with eGFR as low as 20 mL/min/1.73 m2.
A total of 6609 people with CKD and either an eGFR of 20–45 or an eGFR of 45–90 plus an urinary albumin:creatinine ratio (ACR) of ≥200 mg/g (≥26.6 mg/mmol) were randomised to empagliflozin or placebo. The trial was ended early due to prespecified efficacy endpoints being met. Over a median of 2 years’ follow-up, the primary endpoint, a composite of renal disease progression or death from cardiovascular causes, occurred in 13.1% of empagliflozin recipients versus 16.9% of placebo recipients (hazard ratio 0.72; 95% CI 0.64–0.82). The rate of all-cause hospitalisation was lower in the empagliflozin group (hazard ratio, 0.86; 95% CI 0.78–0.95).
There were no significant differences in rates of all-cause mortality or the composite outcome of hospitalisation for heart failure or cardiovascular death; however, this may have been due to the low number of events owing to the early discontinuation of the trial.
Results were consistent irrespective of type 2 diabetes status and across subgroups defined according to eGFR ranges. The rates of serious adverse events were similar in the empagliflozin and placebo groups.
