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Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes
Open accessAbstract
BACKGROUND: Diabetes confers an increased risk of adverse cardiovascular and renal events. In the EMPA-REG OUTCOME trial, empagliflozin, a sodium-glucose cotransporter 2 inhibitor, reduced the risk of major adverse cardiovascular events in patients with type 2 diabetes at high risk for cardiovascular events. We wanted to determine the long-term renal effects of empagliflozin, an analysis that was a prespecified component of the secondary microvascular outcome of that trial. METHODS: We randomly assigned patients with type 2 diabetes and an estimated glomerular filtration rate of at least 30 ml per minute per 1.73 m(2) of body-surface area to receive either empagliflozin (at a dose of 10 mg or 25 mg) or placebo once daily. Prespecified renal outcomes included incident or worsening nephropathy (progression to macroalbuminuria, doubling of the serum creatinine level, initiation of renal-replacement therapy, or death from renal disease) and incident albuminuria. RESULTS: Incident or worsening nephropathy occurred in 525 of 4124 patients (12.7%) in the empagliflozin group and in 388 of 2061 (18.8%) in the placebo group (hazard ratio in the empagliflozin group, 0.61; 95% confidence interval, 0.53 to 0.70; P<0.001). Doubling of the serum creatinine level occurred in 70 of 4645 patients (1.5%) in the empagliflozin group and in 60 of 2323 (2.6%) in the placebo group, a significant relative risk reduction of 44%. Renal-replacement therapy was initiated in 13 of 4687 patients (0.3%) in the empagliflozin group and in 14 of 2333 patients (0.6%) in the placebo group, representing a 55% lower relative risk in the empagliflozin group. There was no significant between-group difference in the rate of incident albuminuria. The adverse-event profile of empagliflozin in patients with impaired kidney function at baseline was similar to that reported in the overall trial population. CONCLUSIONS: In patients with type 2 diabetes at high cardiovascular risk, empagliflozin was associated with slower progression of kidney disease and lower rates of clinically relevant renal events than was placebo when added to standard care. (Funded by the Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance; EMPA-REG OUTCOME ClinicalTrials.gov number, NCT01131676.).
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“Additionally, the risk of AKI is actually reduced by 25% with SGLT2i use in persons with T2D.461”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [461]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“In recent years, sodium–glucose cotransporter 2 inhibitors (SGLT2is) and glucagon-like peptide-1 receptor antagonists (GLP-1RAs) have demonstrated benefits in preventing deleterious cardiorenal endpoints among individuals with type 2 diabetes, shifting disease management from a glucocentric approach to one that prioritises long-term cardiorenal health [5–7].”
From Racial and ethnic disparities in the uptake of SGLT2is and GLP-1RAs among Medicare beneficiaries with type 2 diabetes and heart failure, atherosclerotic cardiovascular disease and chronic kidney disease, 2013–2019 (2025) · cites this paper as [5]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“For example, SGLT2 inhibitors reduce renal tubular glucose reabsorption, weight, systemic blood pressure, intraglomerular pressure, and albuminuria and slow GFR loss through mechanisms that appear independent of glycemia (31,(89)(90)(91)(92).”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [31]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“There was concern that sodium-glucose cotransporter 2 (SGLT2) inhibitors may promote AKI through volume depletion, particularly when combined with diuretics or other medications that reduce glomerular filtration; however, this has not been found to be true in randomized controlled trials of advanced kidney disease (29) or high CVD risk with normal kidney function (30)(31)(32).”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [31]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“For example, SGLT2 inhibitors reduce kidney tubular glucose reabsorption, weight, systemic blood pressure, intraglomerular pressure, and albuminuria and slow GFR loss through mechanisms that appear independent of glycemia (31,(97)(98)(99)(100)(101).”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [31]
Experimental — accuracy not yet measured
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“while the glucose-lowering effects of SGLT2 inhibitors are blunted with eGFR <45 mL/min/1.73m 2 , the kidney and cardiovascular benefits were still seen at eGFR levels as low as 20 mL/min/ 1.73 m 2 even with no significant change in glucose (4,29,31,107,123,127,129,130).”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [31]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Large clinical trials have shown benefits of newer glucose-lowering medications on cardiovascular and kidney outcomes in patients with CKD with type 2 diabetes.5, 6, 7, 8, 9, 10, 11, 12, 13, 14”
From Disparities in SGLT2 Inhibitor or Glucagon-Like Peptide 1 Receptor Agonist Initiation Among Medicare-Insured Adults With CKD in the United States (2023) · cites this paper as [9]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
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“As in other trials of SGLT2 inhibitors, there was an initial dip in the estimated GFR, followed by a stabilization of kidney-function decline.7,8,10”
From Dapagliflozin in Patients with Chronic Kidney Disease (2020) · cites this paper as [7]
The cited source says what the claim attributes to it.
In the citing paper
“There was concern that sodium-glucose cotransporter 2 (SGLT2) inhibitors may promote AKI through volume depletion, particularly when combined with diuretics or other medications that reduce glomerular filtration; however, this has not been found to be true in randomized controlled trials of advanced kidney disease (29) or high CVD risk with normal kidney function (30)(31)(32).”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [31]
The cited source says what the claim attributes to it.
In the citing paper
“Large-scale cardio vascular outcome trials [10][11][12][13][14][15] of SGLT2 inhibitors, which were originally designed to meet regulatory requirements and ensure cardiovascular safety, have shown promising effects on a range of albuminuria and serum creatinine-based kidney outcomes in patients with, or at high risk of, atherosclerotic cardiovascular disease.”
From SGLT2 inhibitors for the prevention of kidney failure in patients with type 2 diabetes: a systematic review and meta-analysis (2019) · cites this paper as [11]
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In the citing paper
“In cardiovascular trials of inhibitors of sodium-glucose cotransporter 2 (SGLT2), exploratory results have suggested that such drugs may improve renal outcomes in patients with type 2 diabetes.”
From Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy (2019) · cites this paper as [9]
In the citing paper
“In clinical trials designed to demonstrate the CVD safety of SGLT2 inhibitors in type 2 diabetes mellitus (T2DM), consistent reductions in risks for secondary kidney disease end points (albuminuria and a composite of serum creatinine doubling or 40% estimated glomerular filtration rate decline, kidney failure, or death), along with reductions in CVD events, were observed.”
From SGLT2 inhibition for CKD and cardiovascular disease in type 2 diabetes: report of a scientific workshop sponsored by the National Kidney Foundation (2021) · cites this paper as [11]
In the citing paper
“The first reported cardiovascular disease (CVD) outcome trial (CVOT) to demonstrate safety of an SGLT2 inhibitor, the EMPA-REG OUTCOME trial, was also the first to show clear benefit of a particular glucose-lowering agent for protection against major adverse cardiovascular events (MACE) in people with T2DM and ASCVD.”
From SGLT2 inhibition for CKD and cardiovascular disease in type 2 diabetes: report of a scientific workshop sponsored by the National Kidney Foundation (2021) · cites this paper as [11]
In the citing paper
“Empagliflozin also reduced the risk for secondary kidney disease end points (albuminuria progression, serum creatinine doubling, kidney failure, and death) (11).”
From SGLT2 inhibition for CKD and cardiovascular disease in type 2 diabetes: report of a scientific workshop sponsored by the National Kidney Foundation (2021) · cites this paper as [11]
In the citing paper
“Diuresis is an important mechanism for reducing blood pressure and risk for HF events (11–16,35).”
From SGLT2 inhibition for CKD and cardiovascular disease in type 2 diabetes: report of a scientific workshop sponsored by the National Kidney Foundation (2021) · cites this paper as [11]
In the citing paper
“Reductions in hospitalizations for HF were seen in EMPA-REG OUTCOME, CANVAS, and DECLARE-TIMI 58, including patients with and without prevalent ASCVD and those with and without a history of HF.”
From SGLT2 inhibition for CKD and cardiovascular disease in type 2 diabetes: report of a scientific workshop sponsored by the National Kidney Foundation (2021) · cites this paper as [11]
In the citing paper
“EMPA-REG OUTCOME was the first CVOT to demonstrate that treatment with an SGLT2 inhibitor, empagliflozin, reduced the risk for a secondary kidney disease outcome (severely increased albuminuria, doubling of serum creatinine accompanied by eGFR ≤45 mL/min/1.73 m2, initiation of KRT, or death from kidney disease) to 12.7% versus 18.8% in the placebo group (HR, 0.61; 95% CI, 0.53–0.70) (11).”
From SGLT2 inhibition for CKD and cardiovascular disease in type 2 diabetes: report of a scientific workshop sponsored by the National Kidney Foundation (2021) · cites this paper as [11]
In the citing paper
“This effect was observed in CANVAS (12) and DECLARE-TIMI-58 (67), but not in the EMPA-REG OUTCOME trial (11).”
From SGLT2 inhibition for CKD and cardiovascular disease in type 2 diabetes: report of a scientific workshop sponsored by the National Kidney Foundation (2021) · cites this paper as [11]
In the citing paper
“Importantly, after the first 4 weeks of treatment during which eGFR declined with empagliflozin, eGFR stabilized in the empagliflozin groups and declined steadily in the placebo group.”
From SGLT2 inhibition for CKD and cardiovascular disease in type 2 diabetes: report of a scientific workshop sponsored by the National Kidney Foundation (2021) · cites this paper as [11]
In the citing paper
“In the CVOTs and CREDENCE, kidney-protective effects are consistent overall (Fig. 6) (69) and in participants with different levels of glycemic control (HbA1c <7% or >9%) or eGFR strata (>90, 60–90, or 30–60 mL/min/1.73 m2) (11,12,14,70).”
From SGLT2 inhibition for CKD and cardiovascular disease in type 2 diabetes: report of a scientific workshop sponsored by the National Kidney Foundation (2021) · cites this paper as [11]
In the citing paper
“and progression of chronic kidney disease (12.7% versus 18.8%; 39% RRR)”
From Clinical management of stable coronary artery disease in patients with type 2 diabetes mellitus: a scientific statement from the American Heart Association (2020) · cites this paper as [220]
In the citing paper
“Recent cardiovascular outcomes trials demonstrate that therapies that inhibit sodium glucose cotransporter (SGLT)2 may reduce heart failure morbidity and mortality and slow decline in renal function (7,8,23,42,43).”
From Evaluation of renal and cardiovascular protection mechanisms of SGLT2 inhibitors: model-based analysis of clinical data (2018) · cites this paper as [42]
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Ipragliflozin improves the hepatic outcomes of patients with diabetes with NAFLD
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Metadata
- Authors
- Wanner, C., Inzucchi, S. E., Lachin, J. M., Fitchett, D., von Eynatten, M., Mattheus, M., Johansen, O. E., Woerle, H. J., Broedl, U. C., & Zinman, B.
- Affiliations
- Mount Sinai Hospital (CA)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2016-07-28
- Volume
- 375
- Issue
- 4
- Pages
- 323-334
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2424539745
- Semantic Scholar
- 508b0daf6c74ba96dda7ddbaf04b0b4b7f8d97f5
- Cited by
- 3,655
- References
- 39
- Citations by year
- 2026: 179 · 2025: 241 · 2024: 289 · 2023: 347 · 2022: 415 · 2021: 425 · 2020: 457 · 2019: 395 · 2018: 418 · 2017: 362 · 2016: 117
- FWCI
- 433.24
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Research Bank (Australian Catholic University) (submittedVersion)
- Florence Research (University of Florence) (submittedVersion)
- Lirias (submittedVersion)
- Topics
- Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Nephrology › Acute Kidney Injury Research
- Keywords
- empagliflozin, SGLT2 inhibitors, type 2 diabetes, kidney disease progression, kidney disease, albuminuria, macroalbuminuria, serum creatinine doubling, renal replacement therapy, renal outcomes, EMPA-REG OUTCOME trial, impaired kidney function, cardiovascular risk, drug safety, adverse events, microvascular outcomes, hospitalization
- MeSH terms
- Aged, Albuminuria, Benzhydryl Compounds, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Diabetic Nephropathies, Female, Glomerular Filtration Rate, Glucosides, Humans, Hypoglycemic Agents, Kidney, Male, Middle Aged, Risk Factors, Proportional Hazards Models, Disease Progression, Kaplan-Meier Estimate, Microvessels, Intention to Treat Analysis
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