Primary and all secondary endpoint(s) met for SGLT2i in kidney outcomes trial
Results of the phase 3 DAPA-CKD trial showed that the SGLT2 inhibitor dapagliflozin significantly reduced the primary endpoint, a composite of worsening of renal function (defined as ≥50% sustained decline in eGFR, onset of end stage kidney disease) or death (CV or renal death), in CKD patients. Also, all secondary endpoints, including risk of death from any cause, were reduced in patients randomized to dapagliflozin compared to placebo.
Safety and tolerability profile was consistent with that observed in previous trials. Full results of the DAPA-CKD trial will be presented at a future meeting.
In March 2020, it was announced that the DAPA-CKD trial was stopped following a recommendation from an independent Data Monitoring Committee based on the determination of overwhelming efficacy.
In May 2020, dapagliflozin was approved by the FDA for the treatment of HFrEF in patients with and without T2DM. Dapagliflozin is under review in Europe and other regions for treatment of HF patients.
DAPA-CKD is an international, multicenter, randomized, double-blinded trial in 4304 patients to examine the efficacy of dapagliflozin compared with placebo in CKD patients stages 2-4 and elevated urinary albumin excretion, with and without T2DM. Primary composite endpoint is worsening of renal function (defined as ≥50% sustained decline in eGFR, onset of end stage kidney disease) or death (CV or renal death). Secondary endpoints included time to first occurrence of the renal composite (sustained ≥50% eGFR decline, ESKD and renal death), the composite of CV death or hHF, and death from any cause.