The dapagliflozin trial investigated the drug’s efficacy in patients with chronic kidney disease (CKD), both with and without type 2 diabetes. The study involved 4304 participants with varying degrees of kidney function and significant albuminuria, who were randomized to receive either 10 mg of dapagliflozin daily or a placebo. The primary goal was to track major outcomes including a 50% or more decline in glomerular filtration rate (GFR), progression to end-stage kidney disease, or death from kidney or heart conditions.
After about 2.4 years of monitoring, only 9.2% of the dapagliflozin group experienced primary outcomes compared to 14.5% in the placebo group, reflecting a hazard ratio of 0.61. The drug markedly lowered the risks of severe kidney decline, kidney disease progression, and death from kidney or cardiovascular causes. Lower overall mortality was also observed in the dapagliflozin group, with these protective effects consistent among all participants, regardless of diabetes status, highlighting its potential in slowing CKD progression and reducing cardiovascular risks.
Reference: Heerspink HJL, Stefánsson BV, Correa-Rotter R, et al. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2020 Oct 8;383(15):1436-1446. doi: 10.1056/NEJMoa2024816. Epub 2020 Sep 24. PMID: 32970396.