Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes
Open accessAbstract
BACKGROUND: The cardiovascular safety profile of dapagliflozin, a selective inhibitor of sodium-glucose cotransporter 2 that promotes glucosuria in patients with type 2 diabetes, is undefined. METHODS: of body-surface area, new end-stage renal disease, or death from renal or cardiovascular causes) and death from any cause. RESULTS: We evaluated 17,160 patients, including 10,186 without atherosclerotic cardiovascular disease, who were followed for a median of 4.2 years. In the primary safety outcome analysis, dapagliflozin met the prespecified criterion for noninferiority to placebo with respect to MACE (upper boundary of the 95% confidence interval [CI], <1.3; P<0.001 for noninferiority). In the two primary efficacy analyses, dapagliflozin did not result in a lower rate of MACE (8.8% in the dapagliflozin group and 9.4% in the placebo group; hazard ratio, 0.93; 95% CI, 0.84 to 1.03; P=0.17) but did result in a lower rate of cardiovascular death or hospitalization for heart failure (4.9% vs. 5.8%; hazard ratio, 0.83; 95% CI, 0.73 to 0.95; P=0.005), which reflected a lower rate of hospitalization for heart failure (hazard ratio, 0.73; 95% CI, 0.61 to 0.88); there was no between-group difference in cardiovascular death (hazard ratio, 0.98; 95% CI, 0.82 to 1.17). A renal event occurred in 4.3% in the dapagliflozin group and in 5.6% in the placebo group (hazard ratio, 0.76; 95% CI, 0.67 to 0.87), and death from any cause occurred in 6.2% and 6.6%, respectively (hazard ratio, 0.93; 95% CI, 0.82 to 1.04). Diabetic ketoacidosis was more common with dapagliflozin than with placebo (0.3% vs. 0.1%, P=0.02), as was the rate of genital infections that led to discontinuation of the regimen or that were considered to be serious adverse events (0.9% vs. 0.1%, P<0.001). CONCLUSIONS: In patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease, treatment with dapagliflozin did not result in a higher or lower rate of MACE than placebo but did result in a lower rate of cardiovascular death or hospitalization for heart failure, a finding that reflects a lower rate of hospitalization for heart failure. (Funded by AstraZeneca; DECLARE-TIMI 58 ClinicalTrials.gov number, NCT01730534 .).
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Trials of heart failure outcomes with dapagliflozin and empagliflozin, enrolling up to 50% of participants with type 2 diabetes, report reduction in cardiovascular death and improvement of heart failure among patients with heart failure with reduced ejection fraction and heart failure with preserved ejection fraction, respectively, independent of diabetes status, compared with placebo.
“Trials of HF outcomes with dapagliflozin and empagliflozin, enrolling up to 50% of participants with type 2 diabetes, report reduction in cardiovascular death and improvement of HF among patients with HF with reduced ejection fraction and HF with preserved ejection fraction, respectively, independent of diabetes status, compared with placebo.66–69,88”
From Diagnosis and Treatment of Type 2 Diabetes in Adults (2025) · cites this paper as [88]
Split into 2 atoms — 0 confirmed, 0 partially supported, 1 disputed, 0 misattributed, 1 unverifiable. Expand the claim to see per-atom verdicts.
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredGallbladder disease is not an issue with SGLT-2 inhibitors, which have similar weight loss.
“as gallbladder disease is not an issue with sodium-glucose co-transporter-2 (SGLT-2) inhibitors (with similar weight loss)”
From Safety of Semaglutide (2021) · cites this paper as [89]
The Effect on Cardiovascular Risk Factors section reports greater weight reduction with dapagliflozin than with placebo (a between-group difference of 1.8 kg). The paper does not address gallbladder disease or establish that its weight loss is similar to that of the treatment implied by the comparison; a search for gallbladder disease, cholelithiasis, and cholecystitis found no relevant passage. Page numbers were not available in our copy. (LLM, conf=0.84)
Experimental — accuracy not yet measuredThere have now been 4 RCTs and a meta-analysis of 4 of these trials that have confirmed significant benefits of SGLT2i on clinically meaningful kidney outcomes beyond just proteinuria as a surrogate marker.
“As discussed, there have now been 4 RCTs 87,89,90,93 and a meta-analysis of 4 of these trials 97 that have con fi rmed the signi fi cant bene fi ts of SGLT2i on clinically meaningful kidney outcomes beyond just proteinuria as a surrogate marker.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [89]
The Outcomes and Cardiovascular and Renal Outcomes sections report a randomized trial with a lower rate of a clinical renal composite—not merely proteinuria—with dapagliflozin than with placebo (4.3% vs. 5.6%; hazard ratio, 0.76; 95% CI, 0.67–0.87). The paper calls analyses of additional outcomes, including this secondary renal outcome, hypothesis-generating, so it does not present that benefit as definitively confirmed. This trial also does not itself establish the cited count of four trials or report the separately cited meta-analysis. (LLM, conf=0.84)
Experimental — accuracy not yet measuredThe recommendation is strong due to the known kidney and/or cardiovascular protective effects in patients with T2D and CKD as shown in high-quality trials, such as EMPA-REG, CANVAS, DECLARE-TIMI 58, CREDENCE, DAPA-CKD, SCORED, DAPA-HF, SOLOIST, EMPEROR-Reduced and EMPEROR-Preserved.
“The recommendation is strong due to the known kidney and/or cardiovascular protective effects in patients with T2D and CKD as shown in high-quality trials, such as EMPA-REG, CANVAS, DECLARE-TIMI 58, CREDENCE, DAPA-CKD, SCORED, DAPA-HF, SOLOIST, EMPEROR-Reduced and EMPEROR-Preserved.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [89]
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 measuredThe clinical trials that may have impacted our results were CANVAS, EMPA-REG OUTCOME, SUSTAIN-6, and LEADER, all of which demonstrated significant cardiovascular and kidney benefits of SGLT-2i and GLP-1RA.
“The clinical trials that may have impacted our results were the CANVAS (canagliflozin, published 2017), EMPA-REG OUTCOME (empagliflozin, 2015), the Trial to Evaluate Cardiovascular and Other Long-term Outcomes with Semaglutide in Subjects with Type 2 Diabetes (SUSTAIN-6) trial (semaglutide, 2016), and the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEAD”
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 [5]
The Trial Design and Oversight section says EMPA-REG OUTCOME findings prompted a change to this paper’s trial protocol. The Discussion describes cardiovascular and renal benefits in prior SGLT2-inhibitor trials, including trials with empagliflozin and canagliflozin. Our copy does not establish the claimed benefits for SUSTAIN-6 or LEADER, or say that all four trials affected the citing authors’ results. Page numbers were not available in the indexed passages. (LLM, conf=0.85)
Experimental — accuracy not yet measured
Stratified analyses of SGLT2 inhibitor trials indicate that older adults have similar or greater benefits than younger people.
“Stratified analyses of the trials of this drug class indicate that older adults have similar or greater benefits than younger people (116-118).”
From 13. Older Adults: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [118]
The Cardiovascular and Renal Outcomes section (page unavailable) says dapagliflozin’s benefit for cardiovascular death or hospitalization for heart failure tended to be similar across subgroups. Our copy does not identify an older-versus-younger comparison or show greater benefit in older adults; it also reports results from this dapagliflozin trial, not a stratified analysis of multiple SGLT2 inhibitor trials. (LLM, conf=0.76)
Experimental — accuracy not yet measuredThe lower risk of heart-failure hospitalization or cardiovascular death with dapagliflozin is consistent with the DECLARE-TIMI 58 and DAPA-HF trials.
“The lower risk of hospitalization for heart failure or death from cardiovascular causes in the dapagliflozin group than in the placebo group is consistent with the results of two previous trials of dapagliflozin, the DECLARE-TIMI 58 (Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58) and DAPA-HF (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure”
From Dapagliflozin in Patients with Chronic Kidney Disease (2020) · cites this paper as [9]
SGLT2i cardiovascular outcome trials reported DKA rates of 0.1-0.6% compared with rates of <0.1-0.3% with placebo.
“The SGLT2i cardiovascular outcome trials (CVOTs) have reported DKA rates of 0.1 -0.6% compared with rates of < 0.1 -0.3% with placebo (143 -147), with very low rates in the HF (148 -151) and CKD (152,153) outcome studies.”
There is substantial evidence confirming that SGLT2i confer significant kidney and heart protective effects in patients with T2D and CKD.
“There is substantial evidence con fi rming that SGLT2i confer signi fi cant kidney and heart protective effects in these patients.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [89]
In DECLARE-TIMI 58, dapagliflozin reduced the second primary efficacy outcome of cardiovascular death or hospitalization for heart failure (HR 0.83; 95% CI 0.73-0.95).
“dapagli fl ozin did reduce the second primary ef fi cacy outcome of cardiovascular death or hospitalization for heart failure (HR: 0.83; 95% CI: 0.73 -0.95).”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [89]
In DECLARE-TIMI 58, dapagliflozin met its primary safety endpoint of noninferiority for MACE, but superiority for MACE did not reach statistical significance.
“dapagli fl ozin met its primary safety endpoint of noninferiority for MACE, but superiority for MACE (1 of 2 primary endpoints) did not reach statistical signi fi cance.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [89]
In DECLARE-TIMI 58, there was a 1.3% absolute and 24% relative risk reduction in the secondary kidney outcome (a composite of ≥40% decrease in eGFR to <60 ml/min per 1.73 m2, kidney failure, and cardiovascular death or death from kidney causes: HR 0.76; 95% CI 0.67-0.87).
“there was a 1.3% absolute and 24% relative risk reduction in the secondary kidney outcome (a composite of a $ 40% decrease in eGFR to < 60 ml/min per 1.73 m 2 , kidney failure, and cardiovascular death or death from kidney causes: HR: 0.76; 95% CI: 0.67 -0.87).”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [89]
In cardiovascular trials of SGLT2 inhibitors, exploratory results have suggested that such drugs may improve renal outcomes in patients with type 2 diabetes.
“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 [7]
The similar rates of amputation and fracture are consistent with trials of other SGLT2 inhibitors but differ from the CANVAS Program findings.
“The similar rates of amputation and fracture that we observed with canagliflozin and placebo are reassuring and consistent with trials of other SGLT2 inhibitors 6,7,20 but differ from the CANVAS Program findings.5”
From Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy (2019) · cites this paper as [7]
In DECLARE-TIMI 58, there was no difference in cardiovascular death between dapagliflozin and placebo groups.
“No difference was seen in cardiovascular death between groups.”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [258]
In DECLARE-TIMI 58, dapagliflozin did not show a lower rate of major adverse cardiovascular events compared with placebo (8.8% vs 9.4%; HR 0.93 [95% CI 0.84-1.03]; P = 0.17).
“but did not show a lower rate of major adverse cardiovascular events compared with placebo (8.8% in the dapagliflozin group and 9.4% in the placebo group; HR 0.93 [95% CI 0.84-1.03];P = 0.17) (258).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [258]
In DECLARE-TIMI 58, dapagliflozin produced a lower rate of hospitalization for heart failure compared with placebo (HR 0.73 [95% CI 0.61-0.88]).
“which reflected a lower rate of hospitalization for heart failure (HR 0.73 [95% CI 0.61-0.88]).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [258]
In DECLARE-TIMI 58, dapagliflozin produced a lower rate of cardiovascular death or hospitalization for heart failure compared with placebo (4.9% vs 5.8%; HR 0.83 [95% CI 0.73-0.95]; P = 0.005).
“A lower rate of cardiovascular death or hospitalization for heart failure was noted (4.9% vs. 5.8%; HR 0.83 [95% CI 0.73-0.95];P = 0.005)”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [258]
In DECLARE-TIMI 58, dapagliflozin met the prespecified criteria for noninferiority to placebo with respect to major adverse cardiovascular events.
“The Dapagliflozin Effect on Cardiovascular Events-Thrombosis in Myocardial Infarction 58 (DECLARE-TIMI 58) trial met the prespecified criteria for noninferiority to placebo with respect to major adverse cardiovascular events”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [258]
In DECLARE-TIMI 58, there was a 27% reduction in hospitalization for heart failure with SGLT2 inhibitor use versus placebo.
“Similarly, in CANVAS and DECLARE-TIMI 58, there were 33% and 27% reductions, respectively, in hospitalization for heart failure with SGLT2 inhibitor use versus placebo (256,258).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [258]
In the DECLARE-TIMI 58 study, dapagliflozin reduced cardiovascular mortality and hospitalization for heart failure by 17%, consistent across multiple study subgroups regardless of prior heart failure.
“In the DECLARE-TIMI 58 study, only 10% of study participants had a prior history of heart failure, and dapagliflozin reduced cardiovascular mortality and hospitalization for heart failure by 17%, which was consistent across multiple study subgroups regardless of a prior history of heart failure (282).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [282]
Large clinical trials have shown benefits of newer glucose-lowering medications on cardiovascular and kidney outcomes in patients with CKD with type 2 diabetes.
“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 [5]
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 [5]
The ERT identified 25 relevant RCTs in an updated Cochrane systematic review.
“Additionally, the ERT identi fi ed 25 relevant RCTs in an updated Cochrane systematic review.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [89]
The Trial Design and Oversight section describes one dapagliflozin RCT, not an ERT review. Searches for the ERT, an updated Cochrane review, and 25 relevant RCTs found no passage in our copy addressing the claim. (LLM, conf=0.77)
Experimental — accuracy not yet measuredHigh-potency GLP-1RA and dual GIP/GLP-1RA medications result in weight loss of greater than 5% in most individuals with type 2 diabetes, and weight loss may exceed 10%.
“High-potency GLP-1RA and dual GIP/GLP-1RA medications result in weight loss of greater than 5% in most individuals with type 2 diabetes, and weight loss may exceed 10%.”
From Diagnosis and Treatment of Type 2 Diabetes in Adults (2025) · cites this paper as [80]
The Effect on Cardiovascular Risk Factors section reports a 1.8 kg greater weight reduction with dapagliflozin than with placebo. It notes some GLP-1 receptor agonist use but does not report weight-loss outcomes for high-potency GLP-1RA or dual GIP/GLP-1RA medications. Searches for those medications and the claimed 5% and 10% thresholds found no supporting passage in our copy. (LLM, conf=0.77)
Experimental — accuracy not yet measuredNewer, high-potency weekly GLP-1RAs (ie, high-dose semaglutide or dulaglutide) and dual GIP/GLP-1RAs (ie, tirzepatide) are associated with mean HbA1C reductions up to approximately 2% to 2.5% and weight reductions of greater than 5% from baseline in most individuals, with some exceeding 10%.
“Newer, high-potency weekly GLP-1RAs (ie, high-dose semaglutide or dulaglutide) and dual GIP/GLP-1RAs (ie, tirzepatide) are associated with mean HbA1C reductions up to approximately 2% to 2.5% and weight reductions of greater than 5% from baseline in most individuals, with some exceeding 10%.80”
From Diagnosis and Treatment of Type 2 Diabetes in Adults (2025) · cites this paper as [80]
Split into 2 atoms — 0 confirmed, 0 partially supported, 0 disputed, 0 misattributed, 2 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredStratified analyses of SGLT2 inhibitor trials indicate that older adults have similar or greater benefits than younger people.
“Stratified analyses of the trials of this drug class indicate that older adults have similar or greater benefits than younger people”
From 13. Older Adults: Standards of Care in Diabetes—2026 (2026) · cites this paper as [141]
The Cardiovascular and Renal Outcomes section (page unavailable) says dapagliflozin’s benefit tended to be similar across subgroups, but our copy does not identify an age-stratified comparison or report benefits for older versus younger adults. Searches for older and younger patients, age subgroups, and age-specific benefits did not locate that comparison. (LLM, conf=0.70)
Experimental — accuracy not yet measuredCanagliflozin, Dapagliflozin, and Sotagliflozin significantly decrease the composite primary endpoint including cardiovascular mortality and other cardiovascular outcomes.
“Canagliflozin, Dapagliflozin, Sotagliflozin significantly decrease the composed primary end-point, including cardiovascular mortality and other cardiovascular outcomes [10,11,12].”
From Neuroprotective effect of SGLT2 inhibitors. (2021) · cites this paper as [11]
Similar findings have been reported in short-term trials of other SGLT2 inhibitors, and longer-term blood pressure-lowering effects in type 2 diabetes with relatively preserved kidney function have been demonstrated in large cardiovascular outcome trials.
“Similar findings have been reported in short-term trials of other SGLT2 inhibitors, 6,18,19 and the longer-term BP lowering effects of SGLT2 inhibitors in individuals with T2DM and relatively preserved kidney function have been demonstrated in large cardiovascular outcome trials.5,20,21”
From Blood Pressure Effects of Canagliflozin and Clinical Outcomes in Type 2 Diabetes and Chronic Kidney Disease: Insights From the CREDENCE Trial (2021) · cites this paper as [21]
In cardiovascular safety trials of SGLT2 inhibitors in type 2 diabetes, secondary kidney endpoints and cardiovascular events were consistently reduced.
“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 [13]
The kidney results were subsequently demonstrated across the SGLT2 inhibitor class with canagliflozin and dapagliflozin in their respective cardiovascular outcome trials.
“These results have subsequently been demonstrated across the class of SGLT2 inhibitors with canagliflozin (12) and dapagliflozin (13) in their respective CVOTs.”
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 [13]
Reductions in hospitalizations for heart failure were seen in EMPA-REG OUTCOME, CANVAS, and DECLARE-TIMI 58, including patients with and without prevalent atherosclerotic cardiovascular disease and those with and without a history of heart failure.
“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 [13]
Diuresis is an important mechanism for reducing blood pressure and risk for heart failure events.
“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 [13]
In DECLARE-TIMI 58, the point estimate of efficacy was numerically lower in participants with atherosclerotic cardiovascular disease (HR 0.90; 95% CI 0.79-1.02) than in those without (HR 1.01; 95% CI 0.86-1.20), but neither subgroup achieved statistical significance nor was the interaction significant.
“The point estimate of efficacy was numerically lower in participants with ASCVD (HR, 0.90; 95% CI, 0.79–1.02) than in those without ASCVD (HR, 1.01; 95% CI, 0.86–1.20), but results in neither subgroup achieved statistical significance nor was the interaction significant.”
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 [13]
In DECLARE-TIMI 58, the overall effect of dapagliflozin on major adverse cardiovascular events was not statistically significantly different versus placebo (HR 0.93; 95% CI 0.84-1.03).
“The overall effect of dapagliflozin on MACE was not statistically significantly different versus placebo (HR, 0.93; 95% CI, 0.84–1.03) (13).”
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 [13]
The cardiovascular outcome trials and CREDENCE were comparable in key aspects: type 2 diabetes participants, placebo controls, SGLT2 inhibitor dose not based on glycemia, all participants treated by standard of care, and similarly defined and adjudicated outcomes.
“The CVOTs designed to test safety and a CKD trial (CREDENCE) were comparable in key aspects: participants with T2DM, placebo controls, SGLT2 inhibitor dose not based on glycemia, all participants treated by standard of care, and similarly defined and adjudicated outcomes.”
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 [13]
In DECLARE-TIMI 58, dapagliflozin significantly reduced the dual primary composite outcome of cardiovascular death or heart failure hospitalization (4.9% versus 5.8%; 17% relative risk reduction).
“Dapagliflozin significantly reduced the risk of the dual primary composite outcome of cardiovascular death or heart failure hospitalization (4.9% versus 5.8%; 17% 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 [16]
In DECLARE-TIMI 58, dapagliflozin did not significantly reduce major adverse cardiovascular events in 17,160 patients with established or at high risk for cardiovascular disease.
“dapagliflozin did not significantly reduce MACEs in 17 160 patients with established or at high risk for cardiovascular disease”
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 [16]
In DECLARE-TIMI 58, dapagliflozin reduced progression of chronic kidney disease.
“and reduced progression of chronic kidney disease”
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 [16]
Large cardiovascular outcome trials first showed that SGLT2 inhibitors slow kidney function decline and reduce kidney outcomes in type 2 diabetes patients, most of whom had relatively preserved kidney function.
“Large cardiovascular outcome trials provided initial proof that SGLT2 inhibitors slow the progression of kidney function decline and reduce the risks of kidney outcomes in patients with T2D of whom the majority had relatively preserved kidney function (Wiviott et al., 2019; Neal et al., 2017; Zinman et al., 2015; 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 Wiviott et al., 2019
DECLARE-TIMI 58 did not show a lower rate of major adverse cardiovascular events with dapagliflozin compared with placebo (8.8% versus 9.4%; HR 0.93, 95% CI 0.84-1.03; P=0.17).
“DECLARE-TIMI 58 met the prespeci fi ed criteria for noninferiority to placebo with respect to major adverse cardiovascular events but did not show a lower rate of major adverse cardiovascular events when compared with placebo (8.8% in the dapagli fl ozin group and 9.4% in the placebo group; HR 0.93 [95% CI 0.84 -1.03]; P = 0.17).”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [196]
DECLARE-TIMI 58 met the prespecified criteria for noninferiority to placebo for major adverse cardiovascular events.
“DECLARE-TIMI 58 met the prespeci fi ed criteria for noninferiority to placebo with respect to major adverse cardiovascular events but did not show a lower rate of major adverse cardiovascular events when compared with placebo (8.8% in the dapagli fl ozin group and 9.4% in the placebo group; HR 0.93 [95% CI 0.84 -1.03]; P = 0.17).”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [196]
In DECLARE-TIMI 58, dapagliflozin lowered the rate of cardiovascular death or hospitalization for heart failure (4.9% versus 5.8%; HR 0.83, 95% CI 0.73-0.95; P=0.005).
“A lower rate of cardiovascular death or hospitalization for heart failure was noted (4.9% vs. 5.8%; HR 0.83 [95% CI 0.73 -0.95]; P = 0.005), which re fl ected a lower rate of hospitalization for heart failure (HR 0.73 [95% CI 0.61 -0.88]).”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [196]
In DECLARE-TIMI 58, there was no difference in cardiovascular death between dapagliflozin and placebo.
“No difference was seen in cardiovascular death between groups.”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [196]
In DECLARE-TIMI 58, dapagliflozin lowered the rate of hospitalization for heart failure (HR 0.73, 95% CI 0.61-0.88).
“A lower rate of cardiovascular death or hospitalization for heart failure was noted (4.9% vs. 5.8%; HR 0.83 [95% CI 0.73 -0.95]; P = 0.005), which re fl ected a lower rate of hospitalization for heart failure (HR 0.73 [95% CI 0.61 -0.88]).”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [196]
Numerous large randomized controlled trials report statistically significant reductions in cardiovascular events for three FDA-approved SGLT2 inhibitors: empagliflozin, canagliflozin, and dapagliflozin, with lesser benefits seen with ertugliflozin.
“In summary, there are now numerous large randomized controlled trials reporting statistically signi fi cant reductions in cardiovascular events for three of the FDA-approved SGLT2 inhibitors (empagli fl ozin, canagli fl ozin, dapagli fl ozin, with lesser bene fi ts seen with ertugli fl ozin)”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [196]
Use of SGLT2 inhibitors has been associated with reduced incidence of heart failure.
“Reduced incidence of heart failure has been observed with the use of SGLT2 inhibitors (8,194,196).”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [196]
In CANVAS and DECLARE-TIMI 58, SGLT2 inhibitor use versus placebo reduced heart failure hospitalization by 33% and 27%, respectively.
“Similarly, in CANVAS and DECLARE-TIMI 58, there were 33% and 27% reductions in hospitalization for heart failure, respectively, with SGLT2 inhibitor use versus placebo (9,196).”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [196]
SGLT2 inhibitors improve cardiovascular outcomes in patients with type 2 diabetes.
“Sodium-glucose cotransporter 2 (SGLT2) inhibitors have recently been shown to improve cardiovascular outcomes in patients with type 2 diabetes.”
From Efficacy of Dapagliflozin on Renal Function and Outcomes in Patients With Heart Failure With Reduced Ejection Fraction: Results of DAPA-HF (2021) · cites this paper as [6]
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Self-citationType 2 diabetes mellitus in older adults: clinical considerations and management
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Self-citationInsulin Resistance and Atherosclerosis: Implications for Insulin-Sensitizing Agents
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10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i>
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Self-citationThe cardio-renal-metabolic connection: a review of the evidence
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13. Older Adults: <i>Standards of Medical Care in Diabetes—2022</i>
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10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025
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11. Chronic Kidney Disease and Risk Management: <i>Standards of Medical Care in Diabetes—2022</i>
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11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2025
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Nonalcoholic fatty liver disease in adults: current concepts in etiology, outcomes, and management
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13. Older Adults: Standards of Care in Diabetes—2025
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Self-citationEffects of dapagliflozin in stage 4 chronic kidney disease
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Anti-diabetic drugs and weight loss in patients with type 2 diabetes
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- Authors
- Wiviott, S. D., Raz, I., Bonaca, M. P., Mosenzon, O., Kato, E. T., Cahn, A., Silverman, M. G., Zelniker, T. A., Kuder, J. F., Murphy, S. A., Bhatt, D. L., Leiter, L. A., McGuire, D. K., Wilding, J. P. H., Ruff, C. T., Gause-Nilsson, I. A. M., Fredriksson, M., Johansson, P. A., Langkilde, A.-M., & Sabatine, M. S.
- Affiliations
- Brigham and Women's Hospital (US)
- From the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women’s Hospital (S.D.W., M.P.B., T.A.Z., J.F.K., S.A.M., D.L.B., C.T.R., M.S.S.), and the Cardiology Division, Massachusetts General Hospital (M.G.S.) — both in Boston; the Diabetes Unit, Hadassah Hebrew University Hospital, Jerusalem (I.R., O.M., A.C.); the Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan (E.T.K.); Li Ka Shing...
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2019-01-24
- Volume
- 380
- Issue
- 4
- Pages
- 347-357
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2900413769
- Semantic Scholar
- 45eef930c8461643cc446df74eddd8076afd0849
- Cited by
- 6,382
- References
- 41
- Citations by year
- 2026: 509 · 2025: 651 · 2024: 807 · 2023: 844 · 2022: 875 · 2021: 1053 · 2020: 957 · 2019: 640 · 2018: 23 · 2017: 4 · 2016: 3 · 2015: 1 · 2014: 1 · 2013: 1 · 2012: 1
- FWCI
- 531.35
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- HAL (submittedVersion)
- BOA (University of Milano-Bicocca) (submittedVersion)
- Funders
- AstraZeneca
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
- Keywords
- dapagliflozin, SGLT2 inhibitors, type 2 diabetes, cardiovascular outcomes, major adverse cardiovascular events, heart failure hospitalization, cardiovascular mortality, renal outcomes, end-stage renal disease, diabetic ketoacidosis, cardiovascular safety, glycosuria, atherosclerotic cardiovascular disease, renal function decline
- MeSH terms
- Sodium-Glucose Transporter 2 Inhibitors, Aged, Benzhydryl Compounds, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Female, Glucosides, Heart Failure, Hospitalization, Humans, Male, Middle Aged
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