Long-Term Effects of Empagliflozin in Patients with Chronic Kidney Disease.
Post-trial follow-up of EMPA-KIDNEY showed that empagliflozin's cardiorenal benefits in chronic kidney disease persisted for up to about 12 months after the drug was discontinued.
Background
In the EMPA-KIDNEY trial, the SGLT2 inhibitor empagliflozin reduced the risk of kidney disease progression or cardiovascular death in a broad population of patients with chronic kidney disease at risk for progression. This post-trial follow-up was designed to assess how those effects would evolve after discontinuation of the trial drug.
Study design
In the active trial, 6,609 patients with chronic kidney disease were randomized to empagliflozin 10 mg once daily or placebo and followed for a median of 2 years. Surviving consenting patients were then observed for 2 additional years without trial drug, although local practitioners could prescribe open-label SGLT2 inhibitors. A total of 4,891 patients (74%) entered the post-trial period, during which open-label SGLT2 inhibitor use was similar between groups (43% empagliflozin vs 40% placebo).
Key findings
Across the combined active and post-trial periods, a primary-outcome event of kidney disease progression or cardiovascular death occurred in 26.2% of the empagliflozin group versus 30.3% of the placebo group (hazard ratio 0.79; 95% CI 0.72 to 0.87). During the post-trial period alone, the hazard ratio was 0.87 (95% CI 0.76 to 0.99). Kidney disease progression, the composite of death or end-stage kidney disease, and cardiovascular death were all lower with empagliflozin, with no effect on noncardiovascular death.
Clinical implications
Empagliflozin continued to provide additional cardiorenal benefit for up to roughly 12 months after it was stopped, indicating a carryover, or legacy, effect. The findings reinforce the role of SGLT2 inhibition as standard care across a wide range of patients with chronic kidney disease.
Category
Research
Source
N Engl J Med
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