Empagliflozin and clinical outcomes in patients with type 2 diabetes mellitus, established cardiovascular disease, and chronic kidney disease
Abstract
Background: Empagliflozin, a sodium-glucose cotransporter 2 inhibitor, reduced cardiovascular morbidity and mortality in patients with type 2 diabetes mellitus and established cardiovascular disease in the EMPA-REG OUTCOME trial (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients). Urinary glucose excretion with empagliflozin decreases with declining renal function, resulting in less potency for glucose lowering in patients with kidney disease. We investigated the effects of empagliflozin on clinical outcomes in patients with type 2 diabetes mellitus, established cardiovascular disease, and chronic kidney disease. Methods: Patients with type 2 diabetes mellitus, established cardiovascular disease, and estimated glomerular filtration rate (eGFR) ≥30 mL·min −1 ·1.73 m −2 at screening were randomized to receive empagliflozin 10 mg, empagliflozin 25 mg, or placebo once daily in addition to standard of care. We analyzed cardiovascular death, hospitalization for heart failure, all-cause hospitalization, and all-cause mortality in patients with prevalent kidney disease (defined as eGFR <60 mL·min −1 ·1.73 m −2 and/or urine albumin-creatinine ratio >300 mg/g) at baseline. Additional analyses were performed in subgroups by baseline eGFR (<45, 45–<60, 60–<90, ≥90 mL·min −1 ·1.73 m −2 ) and baseline urine albumin-creatinine ratio (>300, 30–≤300, <30 mg/g). Results: Of 7020 patients treated, 2250 patients had prevalent kidney disease at baseline, of whom 67% had a diagnosis of type 2 diabetes mellitus for >10 years, 58% were receiving insulin, and 84% were taking angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. In patients with prevalent kidney disease at baseline, empagliflozin reduced the risk of cardiovascular death by 29% compared with placebo (hazard ratio [HR], 0.71; 95% confidence interval [CI], 0.52–0.98), the risk of all-cause mortality by 24% (HR, 0.76; 95% CI, 0.59–0.99), the risk of hospitalization for heart failure by 39% (HR, 0.61; 95% CI, 0.42–0.87), and the risk of all-cause hospitalization by 19% (HR, 0.81; 95% CI, 0.72–0.92). Effects of empagliflozin on these outcomes were consistent across categories of eGFR and urine albumin-creatinine ratio at baseline and across the 2 doses studied. The adverse event profile of empagliflozin in patients with eGFR <60 mL·min −1 ·1.73 m −2 was consistent with the overall trial population. Conclusions: Empagliflozin improved clinical outcomes and reduced mortality in vulnerable patients with type 2 diabetes mellitus, established cardiovascular disease, and chronic kidney disease. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01131676.
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In a prespecified analysis from EMPA-REG of patients with prevalent kidney disease defined as eGFR <60 ml/min per 1.73 m2 and/or ACR >300 mg/g, empagliflozin compared to placebo was associated with reduction in cardiovascular death (HR 0.71; 95% CI 0.52-0.98).
“empagli fl ozin compared to placebo was associated with reduction in cardiovascular death (HR: 0.71; 95% CI: 0.52 -0.98)”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [106]
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredIn the same prespecified EMPA-REG analysis of patients with prevalent kidney disease, empagliflozin compared to placebo was associated with reduction in all-cause mortality (HR 0.76; 95% CI 0.59-0.99).
“all-cause mortality (HR: 0.76; 95% CI: 0.59 -0.99)”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [106]
The Abstract reports the claimed reduction in all-cause mortality among patients with prevalent kidney disease, with the exact HR of 0.76 and 95% CI of 0.59–0.99. However, Statistical Analyses labels the subgroup defined by eGFR or macroalbuminuria—the paper's definition of prevalent kidney disease—as post-hoc, not prespecified. Page numbers were not available in our copy. (LLM, conf=0.90)
Experimental — accuracy not yet measuredIn the same prespecified EMPA-REG analysis of patients with prevalent kidney disease, empagliflozin compared to placebo was associated with reduction in heart failure hospitalization (HR 0.61; 95% CI 0.42-0.87).
“and heart failure hospitalization (HR: 0.61; 95% CI: 0.42 -0.87).”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [106]
The Outcomes in Patients With T2DM and Prevalent Kidney Disease section reports fewer heart-failure hospitalizations with empagliflozin than placebo, with exactly HR 0.61 (95% CI 0.42–0.87). However, Statistical Analyses labels the subgroup defined by eGFR or macroalbuminuria—the prevalent-kidney-disease group—as post-hoc, not prespecified. Page numbers were not available in our copy. (LLM, conf=0.88)
Experimental — accuracy not yet measuredGiven consistent effects over time and across stages of CKD, no particular eGFR subgroup appears to derive more prominent benefits than the others.
“Given consistent effects over time and across stages of CKD, no particular eGFR subgroup appears to derive more prominent benefits than the others (71).”
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 [71]
Recent cardiovascular outcomes trials demonstrate that SGLT2 inhibitors may reduce heart failure morbidity and mortality and slow decline in renal function.
“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 [43]
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Glucose-Lowering Medication Use in CKD: Analysis of US Medicare Beneficiaries Between 2007 and 2016
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- Authors
- Wanner, C., Lachin, J. M., Inzucchi, S. E., Fitchett, D., Mattheus, M., George, J., Woerle, H. J., Broedl, U. C., von Eynatten, M., & Zinman, B.
- Affiliations
- University of Würzburg (DE)
- George Washington University (US)
- Yale University (US)
- St. Michael's Hospital (CA)
- Boehringer Ingelheim (Germany) (DE)
- Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany (M.M., J.G., H.J.W., U.C.B., M.v.E.)
- Mount Sinai Hospital (CA)
- ORCID
- Venue
- Circulation
- Published
- 2018-01-09
- Volume
- 137
- Issue
- 2
- Pages
- 119-129
- ISSN
- 0009-7322 (ISSN-L)
- 1524-4539
- OpenAlex
- W2756191633
- Cited by
- 469
- References
- 35
- Citations by year
- 2026: 20 · 2025: 32 · 2024: 39 · 2023: 46 · 2022: 57 · 2021: 58 · 2020: 70 · 2019: 79 · 2018: 62 · 2017: 2 · 2016: 1
- FWCI
- 46.02
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Circulation (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Keywords
- empagliflozin, SGLT2 inhibitors, type 2 diabetes, chronic kidney disease, cardiovascular disease, cardiovascular mortality, heart failure hospitalization, all-cause mortality, estimated glomerular filtration rate, albuminuria, EMPA-REG OUTCOME trial, drug safety in kidney disease, urinary glucose excretion, dose-response relationship, subgroup analysis
- MeSH terms
- Sodium-Glucose Transporter 2 Inhibitors, Aged, Albuminuria, Benzhydryl Compounds, Cardiovascular Diseases, Cause of Death, Diabetes Mellitus, Type 2, Female, Glomerular Filtration Rate, Glucosides, Hospitalization, Humans, Kidney, Male, Middle Aged, Risk Factors, Time Factors, Prevalence, Treatment Outcome, Renal Insufficiency, Chronic
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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