Treatment with dapagliflozin produced positive outcomes in patients with kidney disease both with and without type 2 diabetes. The number needed to treat (NNT) was much lower compared with established therapies to prevent a sustained decrease in estimated glomerular filtration rate (eGFR) of ≥50%, end stage renal disease (ESRD), or death from renal or cardiovascular (CV) causes.
The purpose of the DAPA-CKD trial (NCT03036150) was to assess whether dapagliflozin reduced the risk of renal and cardiovascular (CV) events in patients with chronic kidney disease (CKD) with or without type 2 diabetes, compared with placebo . Patients received standard care, including maximum doses of angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). The primary endpoint was a composite of a sustained decrease in eGFR (≥50%), ESRD, and death from renal or CV causes.
The trial was stopped early in March 2020, because of overwhelming efficacy based on 408 primary events (60% of planned events). Baseline characteristics of patients were well balanced between both treatment arms. A total of 4,289 patients completed the study, and over a median of 2.4 years, a primary outcome event occurred in 9.2% of patients in the dapagliflozin group compared with 14.5% of patients in the placebo group (HR 0.61; 95% CI 0.51-0.72; P<0.001). The NNT to prevent 1 primary outcome event was 19 (95% CI 15-27). “This NNT is much lower than what was previously seen with ACE inhibitors and ARBs”, Prof. Hiddo Heerspink (University of Groningen, the Netherlands) said. Dapagliflozin treatment resulted in the desired outcome of a sustained decline in eGFR (≥50%), or death from renal causes (HR 0.56; 95% CI 0.45-0.68; P<0.001). For end-stage renal disease only, the HR was 0.66 (95% CI 0.49-0.90; P=0.0072). The HR for the composite of death from CV or hospitalisation for heart failure was 0.71 (95% CI 0.55-0.92; P=0.0089). All-cause mortality was seen in 4.7% of patients in the dapagliflozin group versus 6.8% in the placebo group (HR 0.69; 95% CI 0.53-0.88; P=0.0035). The effects of dapagliflozin were similar both with and without type 2 diabetes. The safety of dapagliflozin was confirmed, with a similar proportion of patients in the dapagliflozin and placebo group experiencing a serious adverse event.
- Heerspink HJL. Results of the DAPA-CKD trial. EASD 2020. Session: DAPA-CKD trial.
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