Effects of dapagliflozin on development and progression of kidney disease in patients with type 2 diabetes: an analysis from the DECLARE–TIMI 58 randomised trial
Open accessAbstract
Background Sodium-glucose co-transporter-2 (SGLT2) inhibitors have shown beneficial effects on renal outcomes mainly in patients with established atherosclerotic cardiovascular disease. Here we report analyses of renal outcomes with the SGLT2 inhibitor dapagliflozin in the DECLARE-TIMI 58 cardiovascular outcomes trial, which included patients with type 2 diabetes both with and without established atherosclerotic cardiovascular disease and mostly with preserved renal function.Methods In DECLARE-TIMI 58, patients with type 2 diabetes, HbA 1c 6·5-12·0% (47·5-113·1 mmol/mol), with either established atherosclerotic cardiovascular disease or multiple risk factors, and creatinine clearance of at least 60 mL/min were randomly assigned (1:1) to 10 mg dapagliflozin or placebo once daily. A prespecified secondary cardiorenal composite outcome was defined as a sustained decline of at least 40% in estimated glomerular filtration rate [eGFR] to less than 60 mL/min per 1·73m 2, end-stage renal disease (defined as dialysis for at least 90 days, kidney transplantation, or confirmed sustained eGFR <15mL/min per 1·73 m 2), or death from renal or cardiovascular causes; a prespecified renal-specific composite outcome was the same but excluding death from cardiovascular causes. In this renal analysis, we report findings for the components of these composite outcomes, subgroup analysis of these composite outcomes, and changes in eGFR at different timepoints. DECLARE-TIMI 58 is registered with ClinicalTrials.gov, number NCT01730534.Findings The trial took place between April 25, 2013, and Sept 18, 2018; median follow-up was 4·2 years (IQR 3·9-4·4). Of the 17 160 participants who were randomly assigned, 8162 (47·6%) had an eGFR of at least 90 mL/min per 1·73 m 2, 7732 (45·1%) had an eGFR of 60 to less than 90 mL/min per 1·73 m 2, and 1265 (7·4%) had an eGFR of less than 60 mL/min per 1·73 m 2 at baseline (one participant had missing data for eGFR); 6974 (40·6%) had established atherosclerotic cardiovascular disease and 10 186 (59·4%) had multiple risk factors. As previously reported, the cardiorenal secondary composite outcome was significantly reduced with dapagliflozin versus placebo (hazard ratio [HR] 0·76, 95% CI 0·67-0.87; p<0·0001); excluding death from cardiovascular causes, the HR for the renal-specific outcome was 0·53 (0·43-0·66; p<0·0001). We identified a 46% reduction in sustained decline in eGFR by at least 40% to less than 60 mL/min per 1·73 m 2 (120 [1·4% vs 221 [2·6%]; HR 0·54 [95% CI 0·43-0·67]; p<0·0001). The risk of end-stage renal disease or renal death was lower in the dapagliflozin group than in the placebo group (11 [0·1%] vs 27 [0·3%]; HR 0·41 [95% CI 0·20-0·82]; p=0·012). Both the cardiorenal and renal-specific composite outcomes were improved with dapagliflozin versus placebo across various prespecified subgroups, including those defined by baseline eGFR (cardiorenal outcome p interaction=0·97; renal-specific outcome p interaction=0·87) and the presence or absence of established atherosclerotic cardiovascular disease (cardiorenal outcome p interaction=0·67; renal-specific outcome p interaction=0·72). 6 months after randomisation, the mean decrease in eGFR was larger in the dapagliflozin group than in the placebo group. The mean change equalised by 2 years, and at 3 and 4 years the mean decrease in eGFR was less with dapagliflozin than with placebo.Interpretation Dapagliflozin seemed to prevent and reduce progression of kidney disease compared with placebo in this large and diverse population of patients with type 2 diabetes with and without established atherosclerotic cardiovascular disease, most of whom had preserved renal function.Funding AstraZeneca.
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Significant benefits of SGLT2i were shown among the subgroup patients (aged ≥65 years) in the study of EMPAREG, CANVAS, DECLARE, and DAPA-CKD.
“However, significant benefits of SGLT2i were shown among the subgroup patients (aged greater than or equal to 65 years) in the study of EMPAREG, CANVAS, DECLARE, and DAPA-CKD.6, 7, 8,11,12,34”
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 [34]
Five large randomized clinical trials demonstrated cardiovascular benefits and kidney protective benefits of SGLT2i.
“Five large randomized clinical trials (the EMPA-REG OUTCOME, the Canagliflozin Cardiovascular Assessment Study [CANVAS], the Dapagliflozin Effect on Cardiovascular Events–Thrombolysis in Myocardial Infarction 58 [DECLARE–TIMI 58], CREDENCE, and DAPA-CKD) demonstrated cardiovascular benefits, and kidney protective benefits of SGLT2i.5, 6, 7, 8,11,12,34”
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 [34]
The concern that SGLT2i increase risk of UTIs has been refuted in a recent meta-analysis.
“but this has been refuted in a recent meta-analysis.31”
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 [31]
The Discussion addresses acute kidney injury, not urinary tract infections, and the Methods describe an analysis of the DECLARE–TIMI 58 randomised trial rather than a meta-analysis. Searches for urinary tract infection, UTI, and meta-analysis found no passage in our copy addressing whether SGLT2 inhibitors increase UTI risk. (LLM, conf=0.78)
Experimental — accuracy not yet measuredIn the cardiovascular outcome trials and CREDENCE, kidney-protective effects are consistent overall and in participants with different levels of glycemic control (HbA1c below 7% or above 9%) or eGFR strata (above 90, 60-90, or 30-60 mL/min/1.73 m2).
“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 [70]
The effects of SGLT2 inhibitors on kidney disease end points do not differ in patients with established atherosclerotic cardiovascular disease or those with multiple cardiovascular disease risk factors.
“The effects of SGLT2 inhibitors on kidney disease end points do not differ in patients with established ASCVD or those with multiple CVD risk factors (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 [70]
These DAPA-CKD results extend previous DECLARE TIMI-58 findings, where most patients did not have CKD, to patients with impaired kidney function.
“These results also extend previous findings from the DECLARE TIMI-58 trial, in which the vast majority of patients did not have CKD, to patients with impaired kidney function (Mosenzon et al., 2019).”
From A kidney perspective on the mechanism of action of sodium glucose co-transporter 2 inhibitors (2021) · cites this paper as Mosenzon et al., 2019
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“Compared with patients living in the Midwest region, people living in the Northeast, South, or West had higher odds to start SGLT2i.”
BackgroundInfluentialMultidisciplinary Approach to Management and Care of Patients with Type 2 Diabetes Mellitus
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Goldenberg, R. M., Ahooja, V., Clemens, K. K., Gilbert, J. D., Poddar, M., & Verma, S. (2021) · Canadian Journal of Diabetes · doi:10.1016/j.jcjd.2020.09.005 · Cited by 23 · see citing works
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- Authors
- Mosenzon, O., Wiviott, S. D., Cahn, A., Rozenberg, A., Yanuv, I., Goodrich, E. L., Murphy, S. A., Heerspink, H. J. L., Zelniker, T. A., Dwyer, J. P., Bhatt, D. L., Leiter, L. A., McGuire, D. K., Wilding, J. P. H., Kato, E. T., Gause-Nilsson, I. A. M., Fredriksson, M., Johansson, P. A., Langkilde, A. M., Sabatine, M. S., & Raz, I.
- Affiliations
- Hebrew University of Jerusalem (IL)
- Brigham and Women's Hospital (US)
- University Medical Center Groningen (NL)
- Vanderbilt University Medical Center (US)
- St. Michael's Hospital (CA)
- The University of Texas Southwestern Medical Center (US)
- University of Liverpool (GB)
- Kyoto University (JP)
- AstraZeneca (Sweden) (SE)
- Corresponding author
- Mosenzon, Ofri
- ORCID
- Venue
- The Lancet Diabetes & Endocrinology
- Publisher
- Elsevier BV
- Published
- 2019-08
- Volume
- 7
- Issue
- 8
- Pages
- 606-617
- ISSN
- 2213-8587 (ISSN-L)
- OpenAlex
- W2949665037
- Cited by
- 684
- References
- 29
- Citations by year
- 2026: 38 · 2025: 62 · 2024: 71 · 2023: 93 · 2022: 95 · 2021: 114 · 2020: 156 · 2019: 51 · 2017: 1
- FWCI
- 84.37
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The Lancet Diabetes & Endocrinology (publishedVersion)
- PubMed (publishedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
- Funders
- GlaxoSmithKline
- Boehringer Ingelheim
- Eisai
- Merck
- Takeda Pharmaceutical Company
- MedImmune
- Novartis
- Boston Scientific Corporation
- Sanofi
- Regado Biosciences
- Icahn School of Medicine at Mount Sinai
- Deutsche Forschungsgemeinschaft (ZE 1109/1–1)
- Bayer
- Cleveland Clinic
- Daiichi-Sankyo
- Amgen
- Gilead Sciences
- Medicines Company
- Bristol-Myers Squibb
- St. Jude Medical
- MyoKardia
- Eli Lilly and Company
- Duke Clinical Research Institute
- AstraZeneca
- Biotronik
- Boston VA Research Institute
- Janssen Research and Development
- Amarin Corporation
- Abbott Laboratories
- American College of Cardiology Foundation
- Society for Academic Continuing Medical Education
- Mayo Clinic
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
- Health Sciences › Medicine › Nephrology › Acute Kidney Injury Research
- Keywords
- dapagliflozin, SGLT2 inhibitors, type 2 diabetes, kidney disease progression, estimated glomerular filtration rate decline, end-stage renal disease, atherosclerotic cardiovascular disease, DECLARE-TIMI 58, cardiorenal outcomes, renal function, cardiovascular outcomes, subgroup analysis, preserved renal function, cardiovascular risk factors, HbA1c
- MeSH terms
- Sodium-Glucose Transporter 2 Inhibitors, Aged, Benzhydryl Compounds, Diabetes Mellitus, Type 2, Diabetic Nephropathies, Female, Glomerular Filtration Rate, Glucosides, Humans, Male, Middle Aged, Renal Insufficiency
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