The New England Journal of Medicine OCTOBER 08, 2020

Dapagliflozin in Patients with Chronic Kidney Disease

Hiddo J.L. Heerspink, Bergur V. Stefánsson, Ricardo Correa-Rotter, et al. for the DAPA-CKD Trial Committees and Investigators

Bottom Line

In patients with chronic kidney disease, regardless of diabetes status, treatment with the SGLT2 inhibitor dapagliflozin significantly reduces the risk of kidney function decline, end-stage kidney disease, and death from renal or cardiovascular causes.

Key Findings

1. The primary composite endpoint (≥50% eGFR decline, end-stage kidney disease, or renal/cardiovascular death) occurred in 9.2% of the dapagliflozin group compared to 14.5% in the placebo group (Hazard Ratio [HR] 0.61; 95% CI, 0.51 to 0.72; P<0.001).
2. The risk of all-cause mortality was significantly lower in the dapagliflozin arm at 4.7% versus 6.8% in the placebo arm (HR 0.69; 95% CI, 0.53 to 0.88; P=0.004).
3. The trial was stopped early for overwhelming efficacy, with a number needed to treat (NNT) of 19 to prevent one primary outcome event over a median follow-up of 2.4 years.
4. The clinical benefits were consistent across prespecified subgroups, including patients both with and without type 2 diabetes mellitus.

Study Design

Design
RCT
Double-Blind
Sample
4,304
Patients
Duration
2.4 yr
Median
Setting
Multicenter, international
Population Adults with chronic kidney disease (eGFR 25 to 75 ml/min/1.73 m2 and urinary albumin:creatinine ratio 200 to 5000 mg/g) receiving stable, maximally tolerated dose of ACE inhibitors or ARBs.
Intervention Dapagliflozin 10 mg daily
Comparator Placebo
Outcome Composite of sustained decline in eGFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes.

Study Limitations

The study excluded patients with type 1 diabetes and those with specific rapidly progressive renal diseases such as lupus nephritis or ANCA-associated vasculitis.
The trial was terminated early based on interim analysis, which can sometimes lead to an overestimate of the treatment effect size.
Patients were required to be on stable, maximally tolerated doses of renin-angiotensin-aldosterone system inhibitors, potentially limiting the generalizability to patients unable to tolerate these therapies.

Clinical Significance

The DAPA-CKD trial establishes dapagliflozin as a foundational, disease-modifying therapy for patients with chronic kidney disease, providing a major therapeutic option that acts independently of glycemic control to reduce the risk of progression to dialysis or death.

Historical Context

Following the success of SGLT2 inhibitors in glycemic control and cardiovascular outcomes (e.g., in heart failure), the CREDENCE trial previously demonstrated renal benefits in patients with type 2 diabetes; DAPA-CKD extended this evidence base to a broader population of patients with CKD, including those without diabetes, marking a paradigm shift in nephrology.

Guided Discussion

High-yield insights from every perspective

Med Student
Medical Student

What is the primary hemodynamic mechanism by which SGLT2 inhibitors like dapagliflozin exert their nephroprotective effects, and how does this relate to the tubuloglomerular feedback mechanism?

Key Response

SGLT2 inhibitors block sodium-glucose reuptake in the proximal tubule, leading to increased sodium delivery to the macula densa. This restores tubuloglomerular feedback, which triggers afferent arteriolar vasoconstriction. This reduction in intraglomerular pressure mitigates glomerular hyperfiltration, a key driver of progressive kidney damage, especially in diabetic and proteinuric kidney disease.

Resident
Resident

When initiating dapagliflozin in a patient with CKD, how should a clinician interpret an 'initial dip' in the estimated glomerular filtration rate (eGFR), and what is the typical threshold for clinical concern?

Key Response

An initial eGFR dip (often 10-30%) is a common, expected hemodynamic effect reflecting the reduction in glomerular hyperfiltration. It is not indicative of acute kidney injury. Per clinical practice informed by DAPA-CKD and EMPA-KIDNEY, treatment should generally be continued unless the dip exceeds 30% or is accompanied by clinical signs of volume depletion or electrolyte abnormalities.

Fellow
Fellow

DAPA-CKD was landmark for including patients without diabetes. Based on the subgroup analyses, how does the efficacy of dapagliflozin in patients with IgA nephropathy compare to those with other non-diabetic etiologies of CKD?

Key Response

Subgroup analyses from DAPA-CKD demonstrated that the benefits of dapagliflozin were consistent in patients with IgA nephropathy, showing a 71% reduction in the primary outcome for this specific group. This suggests that the anti-inflammatory and hemodynamic benefits of SGLT2 inhibition are highly effective in glomerulonephritides characterized by chronic proteinuria, independent of glucose metabolism.

Attending
Attending

Given the evidence from DAPA-CKD, how does the addition of dapagliflozin to a regimen of maximally tolerated ACE inhibitors or ARBs change the long-term prognosis for patients with Stage 3 or 4 CKD and albuminuria?

Key Response

DAPA-CKD showed that adding dapagliflozin to standard-of-care RAS blockade resulted in a 39% lower risk of the primary composite outcome (decline in eGFR, ESKD, or death from renal/CV causes). For the attending, the teaching point is that SGLT2 inhibitors are no longer just 'diabetes drugs' but are essential, primary nephroprotective agents that provide additive benefits to RAS inhibition.

Scholarly Review

Critical appraisal through the lens of expert reviewers and guideline development

PhD
PhD

The DAPA-CKD trial was stopped early by the independent data monitoring committee due to 'overwhelming efficacy.' What are the statistical implications of early termination on the point estimates and confidence intervals for the primary outcome, and how might this affect our perception of the magnitude of benefit?

Key Response

Early termination for benefit can lead to an overestimation of the treatment effect (the 'winner's curse'), as trials are often stopped at a random high point of observed efficacy. While the statistical significance in DAPA-CKD was robust, the true effect size might be slightly more modest than the reported 39% reduction, although subsequent meta-analyses of SGLT2 trials have largely validated these findings.

Journal Editor
Journal Editor

Considering the inclusion and exclusion criteria of DAPA-CKD, what are the primary threats to the external validity of these findings regarding patients with polycystic kidney disease or those receiving active immunosuppression for lupus nephritis?

Key Response

DAPA-CKD specifically excluded patients with polycystic kidney disease, lupus nephritis, and those on recent immunosuppressive therapy. A critical reviewer would flag that while the trial is groundbreaking for 'general' CKD, its findings cannot be extrapolated to these specific populations where the pathophysiology of progression (e.g., cyst growth or active immune-mediated inflammation) differs significantly from the hyperfiltration model.

Guideline Committee
Guideline Committee

Based on the DAPA-CKD and subsequent EMPA-KIDNEY data, how should current KDIGO guidelines be adjusted regarding the lower eGFR limit for the initiation and continuation of SGLT2 inhibitors in patients with and without type 2 diabetes?

Key Response

DAPA-CKD included patients down to an eGFR of 25 mL/min/1.73m². Current KDIGO 2024 updates now recommend SGLT2 inhibitors as a Grade 1A recommendation for patients with CKD and albuminuria down to an eGFR of 20 mL/min/1.73m². Furthermore, guidelines now emphasize continuing the SGLT2 inhibitor until the initiation of dialysis, even if the eGFR falls below the initiation threshold, to maximize cardiovascular and renal benefits.

Clinical Landscape

Noteworthy Related Trials

2015

EMPA-REG OUTCOME Trial

n = 7,020 · NEJM

Tested

Empagliflozin 10mg or 25mg daily

Population

T2DM patients with high cardiovascular risk

Comparator

Placebo

Endpoint

3-point MACE

Key result: Empagliflozin reduced cardiovascular death and slowed the progression of kidney disease in patients with T2DM.
2019

CREDENCE Trial

n = 4,401 · NEJM

Tested

Canagliflozin 100mg daily

Population

T2DM patients with CKD and albuminuria

Comparator

Placebo

Endpoint

Composite of ESKD, doubling of serum creatinine, or renal/CV death

Key result: Canagliflozin significantly reduced the risk of kidney failure and CV events in patients with T2DM and albuminuric CKD.
2022

EMPA-KIDNEY Trial

n = 6,609 · NEJM

Tested

Empagliflozin 10mg daily

Population

Patients with chronic kidney disease at risk of progression

Comparator

Placebo

Endpoint

Composite of progression of kidney disease or CV death

Key result: Empagliflozin reduced the risk of kidney disease progression or death from CV causes regardless of diabetes status.

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