EMPA-KIDNEY

Population

• Patients with CKD (eGFR 20 to <45, or eGFR 45 to <90 with albumin-to-creatinine ratio >=200), with or without diabetes; broader and less albuminuric than prior SGLT2 renal trials.

Intervention

Empagliflozin 10 mg daily.

Comparator

Placebo, both added to standard care.

Key results

• Primary composite outcome: 13.1% with empagliflozin vs 16.9% with placebo; HR 0.72; 95% CI 0.64-0.82; p<0.001.
• Results were consistent in patients with and without diabetes and across the range of eGFR studied.
• Hospitalization from any cause was lower with empagliflozin (HR 0.86; 95% CI 0.78-0.95).
• There was no significant difference in the composite of heart-failure hospitalization or cardiovascular death, or in all-cause death, over the short follow-up.

Harms

• Rates of serious adverse events were similar between empagliflozin and placebo.
• SGLT2 inhibitors carry a class risk of ketoacidosis and genital mycotic infection.

Practice impact

• Strengthened SGLT2 inhibitor use across a broad CKD population.

Applicability

• Most applicable to a broad CKD population at risk for progression, including many patients without diabetes and with lower albuminuria than earlier SGLT2 trials.

Limitations

• Absolute benefit depends on baseline kidney risk and albuminuria.
• Follow-up was relatively short due to early stopping for efficacy, limiting long-term inference.

Common misinterpretations

• Do not restrict SGLT2 inhibitors to albuminuric or diabetic CKD; EMPA-KIDNEY enrolled a broader, less albuminuric population.
• The neutral cardiovascular-death and all-cause-mortality findings reflect short follow-up, not absence of cardiovascular benefit seen in other SGLT2 trials.