Sotagliflozin in patients with diabetes and chronic kidney disease
Open accessAbstract
BACKGROUND: The efficacy and safety of sodium-glucose cotransporter 2 inhibitors such as sotagliflozin in preventing cardiovascular events in patients with diabetes with chronic kidney disease with or without albuminuria have not been well studied. METHODS: of body-surface area), and risks for cardiovascular disease were randomly assigned in a 1:1 ratio to receive sotagliflozin or placebo. The primary end point was changed during the trial to the composite of the total number of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure. The trial ended early owing to loss of funding. RESULTS: Of 19,188 patients screened, 10,584 were enrolled, with 5292 assigned to the sotagliflozin group and 5292 assigned to the placebo group, and followed for a median of 16 months. The rate of primary end-point events was 5.6 events per 100 patient-years in the sotagliflozin group and 7.5 events per 100 patient-years in the placebo group (hazard ratio, 0.74; 95% confidence interval [CI], 0.63 to 0.88; P<0.001). The rate of deaths from cardiovascular causes per 100 patient-years was 2.2 with sotagliflozin and 2.4 with placebo (hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P = 0.35). For the original coprimary end point of the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, the hazard ratio was 0.84 (95% CI, 0.72 to 0.99); for the original coprimary end point of the first occurrence of death from cardiovascular causes or hospitalization for heart failure, the hazard ratio was 0.77 (95% CI, 0.66 to 0.91). Diarrhea, genital mycotic infections, volume depletion, and diabetic ketoacidosis were more common with sotagliflozin than with placebo. CONCLUSIONS: In patients with diabetes and chronic kidney disease, with or without albuminuria, sotagliflozin resulted in a lower risk of the composite of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure than placebo but was associated with adverse events. (Funded by Sanofi and Lexicon Pharmaceuticals; SCORED ClinicalTrials.gov number, NCT03315143.).
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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.”
From Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) (2022) · cites this paper as [147]
The Adverse Events section (p. 9) reports diabetic ketoacidosis in 0.6% of sotagliflozin recipients versus 0.3% of placebo recipients, matching the upper ends of the quoted ranges. This single trial in patients with diabetes and chronic kidney disease does not establish the lower ends or the range across SGLT2-inhibitor cardiovascular outcome trials. (LLM, conf=0.87)
Experimental — accuracy not yet measuredDirect evidence for safety and benefit of SGLT2i in eGFR 20-29 is provided by the DAPA-CKD, SCORED, EMPEROR-Reduced, and EMPEROR-Preserved trials, which enrolled such participants by design.
“Direct evidence is provided by the DAPA-CKD, SCORED, EMPEROR-Reduced, and EMPEROR-Preserved trials, which enrolled such participants by design.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [96]
The Patients section (p. 4) confirms that SCORED enrolled participants with eGFR 25–60 by design, covering 25–29 but not 20–24. The Discussion (p. 9) reports benefit and adverse events for the trial population overall, not evidence specific to eGFR 20–29. This paper does not establish the enrollment criteria or findings of the other three named trials. (LLM, conf=0.88)
Experimental — accuracy not yet measuredThe studies that led to the approved indication for heart failure (HF) excluded individuals with type 1 diabetes or a history of DKA.
“The studies that led to the approved indication for heart failure (HF) excluded individuals with type 1 diabetes or a history of DKA (82,83).”
From 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025 (2025) · cites this paper as [83]
The Patients section (p. 4) says this trial enrolled people with type 2 diabetes, supporting the claim that it did not include people with type 1 diabetes. It does not state that a history of DKA was an exclusion criterion; the Adverse Events section (p. 9) reports DKA occurring during the trial, not participants' prior history. The copy also does not establish which studies led to an approved heart-failure indication. (LLM, conf=0.84)
Experimental — accuracy not yet measuredThe DAPA-CKD and SCORED trials enrolled CKD patients with an eGFR down to as low as 25 ml/min per 1.73 m2.
“The DAPA-CKD 94 and SCORED 96 trials enrolled CKD patients with an eGFR down to as low as 25 ml/min per 1.73 m 2 .”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [96]
In SCORED, sotagliflozin reduced the original coprimary endpoint of cardiovascular death and heart failure hospitalizations by 23% (HR 0.77; 95% CI 0.66-0.91).
“sotagli fl ozin also reduced the original coprimary endpoint of cardiovascular death and heart failure hospitalizations by 23% (HR: 0.77; 95% CI: 0.66 -0.91).”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [96]
In SCORED, sotagliflozin reduced the primary outcome (composite of cardiovascular death, heart failure hospitalizations, or urgent visits for heart failure) by 26% (HR 0.74; 95% CI 0.63-0.88).
“Sotagli fl ozin reduced this primary outcome by 26% (HR: 0.74; 95% CI: 0.63 -0.88)”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [96]
In SCORED, the secondary composite kidney endpoint of kidney failure or sustained 50% decline in eGFR had an HR of 0.71 (95% CI 0.46-1.08).
“The secondary composite kidney endpoint of kidney failure or sustained 50% decline in eGFR had a HR of 0.71 (95% CI: 0.46 -1.08).”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [96]
In the SCORED trial, randomization to sotagliflozin reduced the primary outcome of death from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in people with type 2 diabetes, CKD, and risk for cardiovascular disease.
“in the Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk (SCORED) trial, randomization to the SGLT1/2 inhibitor sotagliflozin reduced the primary outcome of death from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in people with type 2 diabetes”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [284]
In the SCORED trial, changes to the prespecified primary end points were made prior to unblinding to accommodate a lower-than-anticipated number of end point events.
“Changes to the prespecified primary end points were made prior to unblinding to accommodate a lower-thananticipated number of end point events.”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [284]
In the SCORED trial, the primary end point of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure was reduced with sotagliflozin.
“The primary end point of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure was reduced with sotagliflozin.”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [284]
In the SCORED trial, sotagliflozin reduced the primary outcome of death from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in people with type 2 diabetes, CKD, and risk for CVD.
“Finally, in the Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk (SCORED) trial, randomization to the SGLT1/2 inhibitor sotagliflozin reduced the primary outcome of death from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in people with type 2”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [283]
In patients with chronic kidney disease at high risk of heart failure, a consistent risk reduction of cardiovascular death or heart failure hospitalization was observed ranging from 23% to 31%.
“In these patients at high risk of HF, a consistent risk reduction of CV death or HF hospitalization was observed ranging from 23% to 31%.150,153,542,543”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [150]
In the SCORED trial, sotagliflozin reduced the primary composite of the total number of cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure by 26% versus placebo (HR 0.74; 95% CI, 0.63-0.88; P < 0.001).
“The combined SGLT1/2 inhibitor sotagliflozin was analysed vs. placebo in the SCORED trial in patients with T2DM and CKD (eGFR 25-60 mL/min/ 1.73 m 2 ); sotagliflozin reduced the primary composite of the total number of CV deaths, hospitalizations for HF, and urgent visits for HF by 26% vs. placebo (HR 0.74; 95% CI, 0.63-0.88;P < 0.001).150”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [150]
Sub-group analyses considering those co-prescribed mineralocorticoid receptor antagonists and SGLT2 inhibitors suggest their combined use does not modify safety findings from the key trials.
“Sub-group analyses considering those co-prescribed MRA and SGLT2 inhibitors suggest their combined use does not modify safety findings from the key trials.150,189,[722][723][724][725][726]”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [150]
CREDENCE and SCORED exclusively studied patients with chronic kidney disease and type 2 diabetes.
“CREDENCE and SCORED exclusively studied patients with chronic kidney disease and type 2 diabetes,7, 9”
Sotagliflozin showed a similar but non-significant kidney failure trend in SCORED, likely because the trial ended early.
“A similar trend was observed for sotagliflozin, although the effect was not statistically significant in the SCORED trial, probably due to its early termination (Bhatt et al., 2021).”
From A kidney perspective on the mechanism of action of sodium glucose co-transporter 2 inhibitors (2021) · cites this paper as Bhatt et al., 2021
In SCORED, there were no significant between-group differences for all-cause mortality or for a composite renal outcome of long-term dialysis, renal transplantation, or sustained eGFR reduction.
“No signi fi cant between-group differences were found for the outcome of all-cause mortality or for a composite renal outcome comprising the fi rst occurrence of long-term dialysis, renal transplantation, or a sustained reduction in eGFR.”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [202]
In SCORED, sotagliflozin did not reduce the secondary endpoint of deaths from cardiovascular causes.
“but not the secondary end point of deaths from cardiovascular causes.”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [202]
Sotagliflozin's adverse effects were generally similar to those of SGLT2 inhibitors, but included an increased rate of diarrhea potentially related to SGLT1 inhibition.
“In general, the adverse effects of sotagli fl ozin were similar to those seen with use of SGLT2 inhibitors, but they also included an increased rate of diarrhea potentially related to the inhibition of SGLT1.”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [202]
In SCORED, after a median follow-up of 16 months, sotagliflozin reduced the rate of the primary endpoint of cardiovascular death, heart failure hospitalization, and urgent heart failure visits compared with placebo (5.6 versus 7.5 events per 100 patient-years; HR 0.74, 95% CI 0.63-0.88; P<0.001).
“After a median of 16 months of follow-up, the rate of primary end point events was reduced with sotagli fl ozin (5.6 events per 100 patient-years in the sotagli fl ozin group and 7.5 events per 100 patient-years in the placebo group [HR 0.74 (95% CI 0.63 -0.88); P < 0.001]).”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [202]
SCORED ended early because of lack of funding, and its prespecified primary endpoints were changed before unblinding to accommodate fewer endpoint events than anticipated.
“SCORED ended early due to a lack of funding; thus, changes to the prespeci fi ed primary end points were made prior to unblinding to accommodate a lower than anticipated number of end point events.”
From 10. Cardiovascular Disease and Risk Management: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [202]
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Cites
Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes
Zinman, B., Wanner, C., Lachin, J. M., Fitchett, D., Bluhmki, E., Hantel, S., Mattheus, M., Devins, T., Johansen, O. E., Woerle, H. J., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1504720 · Cited by 12,315 · see citing works
Self-citationCanagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes
Neal, B., Perkovic, V., Mahaffey, K. W., de Zeeuw, D., Fulcher, G., Erondu, N., Shaw, W., Law, G., Desai, M., & Matthews, D. R. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1611925 · Cited by 7,830 · see citing works
Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction
McMurray, J. J. V., Solomon, S. D., Inzucchi, S. E., Køber, L., Kosiborod, M. N., Martinez, F. A., Ponikowski, P., Sabatine, M. S., Anand, I. S., Bělohlávek, J., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1911303 · Cited by 7,140 · see citing works
Self-citationDapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes
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., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1812389 · Cited by 6,382 · see citing works
Self-citationCanagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy
Perkovic, V., Jardine, M. J., Neal, B., Bompoint, S., Heerspink, H. J. L., Charytan, D. M., Edwards, R., Agarwal, R., Bakris, G., Bull, S., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1811744 · Cited by 6,189 · see citing works
Self-citationDapagliflozin in Patients with Chronic Kidney Disease
Heerspink, H. J. L., Stefánsson, B. V., Correa-Rotter, R., Chertow, G. M., Greene, T., Hou, F.-F., Mann, J. F. E., McMurray, J. J. V., Lindberg, M., Rossing, P., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2024816 · Cited by 5,618 · see citing works
Cardiovascular and renal outcomes with empagliflozin in heart failure
Packer, M., Anker, S. D., Butler, J., Filippatos, G., Pocock, S. J., Carson, P., Januzzi, J., Verma, S., Tsutsui, H., Brueckmann, M., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2022190 · Cited by 5,206 · see citing works
Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus
Scirica, B. M., Bhatt, D. L., Braunwald, E., Steg, P. G., Davidson, J., Hirshberg, B., Ohman, P., Frederich, R., Wiviott, S. D., Hoffman, E. B., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1307684 · Cited by 3,470 · see citing works
Self-citationZelniker, T. A., Wiviott, S. D., Raz, I., Im, K., Goodrich, E. L., Bonaca, M. P., Mosenzon, O., Kato, E. T., Cahn, A., Furtado, R. H. M., et al. (2019) · The Lancet · doi:10.1016/s0140-6736(18)32590-x · Cited by 2,845 · see citing works
Self-citationBhatt, D. L. (2006) · JAMA · doi:10.1001/jama.295.2.180 · Cited by 1,628 · see citing works
Self-citationCardiovascular outcomes with ertugliflozin in type 2 diabetes
Cannon, C. P., Pratley, R., Dagogo-Jack, S., Mancuso, J., Huyck, S., Masiukiewicz, U., Charbonnel, B., Frederich, R., Gallo, S., Cosentino, F., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2004967 · Cited by 1,514 · see citing works
Self-citationOne-year cardiovascular event rates in outpatients with atherothrombosis
Steg, P. G., Bhatt, D. L., Wilson, P. W. F., D’Agostino, R., Ohman, E. M., Röther, J., Liau, C.-S., Hirsch, A. T., Mas, J.-L., Ikeda, Y., et al. (2007) · JAMA · doi:10.1001/jama.297.11.1197 · Cited by 1,382 · see citing works
Self-citationClopidogrel with or without Omeprazole in Coronary Artery Disease
Bhatt, D. L., Cryer, B., Contant, C. F., Cohen, M. C., Lanas, A., Schnitzer, T. J., Shook, T., Lapuerta, P., Goldsmith, M. A., Laine, L., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa1007964 · Cited by 1,238 · see citing works
Self-citationBhatt, D. L., Eagle, K. A., Ohman, E. M., Hirsch, A. T., Goto, S., Mahoney, E. M., Wilson, P. W. F., Alberts, M. J., D’Agostino, R., Liau, C.-S., et al. (2010) · JAMA · doi:10.1001/jama.2010.1322 · Cited by 753 · see citing works
Self-citationScirica, B. M., Braunwald, E., Raz, I., Cavender, M. A., Morrow, D. A., Jarolim, P., Udell, J. A., Mosenzon, O., Im, K., Umez-Eronini, A. A., et al. (2014) · Circulation · doi:10.1161/circulationaha.114.010389 · Cited by 725 · see citing works
Self-citationVerma, S., Mazer, C. D., Yan, A. T.-K., Mason, T., Garg, V., Teoh, H., Zuo, F., Quan, A., Farkouh, M. E., FITCHETT, D. H., et al. (2019) · Circulation · doi:10.1161/circulationaha.119.042375 · Cited by 587 · see citing works
Self-citationEffect of dapagliflozin on heart failure and mortality in type 2 diabetes mellitus
Kato, E. T., Silverman, M. G., Mosenzon, O., Zelniker, T. A., Cahn, A., Furtado, R. H. M., Kuder, J., Murphy, S. A., Bhatt, D. L., Leiter, L. A., et al. (2019) · Circulation · doi:10.1161/circulationaha.119.040130 · Cited by 557 · see citing works
Self-citationCavender, M. A., Steg, P. G., Smith, S. C., Eagle, K., Ohman, E. M., Goto, S., Kuder, J., Im, K., Wilson, P. W. F., & Bhatt, D. L. (2015) · Circulation · doi:10.1161/circulationaha.114.014796 · Cited by 501 · see citing works
Self-citationEffects of sotagliflozin added to insulin in patients with type 1 diabetes
Garg, S. K., Henry, R. R., Banks, P., Buse, J. B., Davies, M. J., Fulcher, G. R., Pozzilli, P., Gesty-Palmer, D., Lapuerta, P., Simó, R., et al. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1708337 · Cited by 417 · see citing works
Self-citationUdell, J. A., Cavender, M. A., Bhatt, D. L., Chatterjee, S., Farkouh, M. E., & Scirica, B. M. (2015) · The Lancet Diabetes & Endocrinology · doi:10.1016/s2213-8587(15)00044-3 · Cited by 254 · see citing works
Self-citationBuse, J. B., Garg, S. K., Rosenstock, J., Bailey, T. S., Banks, P., Bode, B. W., Danne, T., Kushner, J. A., Lane, W. S., Lapuerta, P., et al. (2018) · Diabetes Care · doi:10.2337/dc18-0343 · Cited by 234 · see citing works
Self-citationSotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, as Adjunct Therapy to Insulin in Type 1 Diabetes
Sands, A., Zambrowicz, B., Rosenstock, J., Lapuerta, P., Bode, B. W., Garg, S. K., Buse, J. B., Banks, P. L., Heptulla, R. A., Rendell, M., et al. (2015) · Diabetes Care · doi:10.2337/dc14-2806 · Cited by 216 · see citing works
Self-citationDanne, T., Cariou, B., Banks, P. L., Brändle, M., Brath, H., Franek, E., Kushner, J. A., Lapuerta, P., McGuire, D. K., Peters, A. L., et al. (2018) · Diabetes Care · doi:10.2337/dc18-0342 · Cited by 186 · see citing works
Self-citationUdell, J. A., Bhatt, D. L., D, E. B. M., Cavender, M. A., Mosenzon, O., Steg, P. G., Davidson, J. A., Nicolau, J. C., Corbalan, R. L., Hirshberg, B., et al. (2014) · Diabetes Care · doi:10.2337/dc14-1850 · Cited by 163 · see citing works
Self-citationChowdhury, B., Luu, A. Z., Luu, V. Z., Kabir, M. G., Pan, Y., Teoh, H., Quan, A., Sabongui, S., Al-Omran, M. A., Bhatt, D. L., et al. (2020) · Biochemical and Biophysical Research Communications · doi:10.1016/j.bbrc.2020.01.015 · Cited by 133 · see citing works
Self-citationPrescriber Patterns of SGLT2i After Expansions of U.S. Food and Drug Administration Labeling
Vaduganathan, M., Sathiyakumar, V., Singh, A., McCarthy, C. P., Qamar, A., Januzzi, J. L., Scirica, B. M., Butler, J., Cannon, C. P., & Bhatt, D. L. (2018) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2018.08.2202 · Cited by 123 · see citing works
Self-citationHess, D. A., Terenzi, D. C., Trac, J. Z., Quan, A., Mason, T., Al-Omran, M. A., Bhatt, D. L., Dhingra, N., Rotstein, O. D., Leiter, L. A., et al. (2019) · Cell Metabolism · doi:10.1016/j.cmet.2019.08.015 · Cited by 112 · see citing works
Self-citationScirica, B. M., Bhatt, D. L., D, E. B. M., Raz, I., Cavender, M. A., Im, K., Mosenzon, O., Udell, J. A., Hirshberg, B., Pollack, P. S., et al. (2016) · JAMA Cardiology · doi:10.1001/jamacardio.2016.3030 · Cited by 102 · see citing works
Self-citationGenetic Variants in SGLT1, Glucose Tolerance, and Cardiometabolic Risk
Seidelmann, S. B., Feofanova, E., Yu, B., Franceschini, N., Claggett, B., Kuokkanen, M., Puolijoki, H., Ebeling, T., Perola, M., Salomaa, V., et al. (2018) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2018.07.061 · Cited by 97 · see citing works
The Consequences of the COVID-19 Pandemic on Non-COVID-19 Clinical Trials
Bagiella, E., Bhatt, D. L., & Gaudino, M. F. L. (2020) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2020.05.041 · Cited by 61 · see citing works
Self-citationThe DAPA-HF Trial: A Momentous Victory in the War against Heart Failure
Bhatt, D. L., Verma, S., & D, E. B. M. (2019) · Cell Metabolism · doi:10.1016/j.cmet.2019.10.008 · Cited by 58 · see citing works
Self-citationPowell, D. R., Zambrowicz, B., Morrow, L., Beysen, C., Hompesch, M., Turner, S., Hellerstein, M. K., Banks, P. L., Strumph, P., & Lapuerta, P. (2019) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/clinem/dgz258 · Cited by 58 · see citing works
Self-citationStandardized rates of recurrent outcomes
Stukel, T. A., Glynn, R. J., Fisher, E. S., Sharp, S. M., Lu‐Yao, G. L., & Wennberg, J. E. (1994) · Statistics in Medicine · doi:10.1002/sim.4780131709 · Cited by 55 · see citing works
Avogaro, A., Fadini, G. P., & Prato, S. D. (2019) · Diabetes Care · doi:10.2337/dc19-1410 · Cited by 50 · see citing works
The COVID-19 pandemic: a catalyst to improve clinical trials
Gaba, P., & Bhatt, D. L. (2020) · Nature Reviews Cardiology · doi:10.1038/s41569-020-00439-7 · Cited by 49 · see citing works
Self-citationEmpagliflozin improves cardiorespiratory fitness in type 2 diabetes: translational implications
Kumar, N., Garg, A., Bhatt, D. L., Sabongui, S., Gupta, N. K., Chaudhry, S., Arena, R. A., & Verma, S. (2018) · Canadian Journal of Physiology and Pharmacology · doi:10.1139/cjpp-2018-0359 · Cited by 32 · see citing works
Self-citationOpingari, E., Verma, S., Connelly, K. A., Mazer, C. D., Teoh, H., Quan, A., Zuo, F., Pan, Y., Bhatt, D. L., Zinman, B., et al. (2020) · Nephrology Dialysis Transplantation · doi:10.1093/ndt/gfz294 · Cited by 30 · see citing works
Self-citationVerma, S., Mazer, C. D., Bhatt, D. L., Raj, S. R., Yan, A. T.-K., Verma, A., Ferrannini, E., Simons, G., Lee, J., Zinman, B., et al. (2019) · Diabetes Care · doi:10.2337/dc18-1959 · Cited by 29 · see citing works
Self-citationModeling marginal features in studies of recurrent events in the presence of a terminal event
Andersen, P. K., Angst, J., & Ravn, H. (2019) · Lifetime Data Analysis · doi:10.1007/s10985-019-09462-4 · Cited by 29 · see citing works
Tyl, B., Lopez Sendon, J., Borer, J. S., Lopez De Sa, E., Lerebours, G., Varin, C., De Montigny, A., Pannaux, M., & Komajda, M. (2020) · Circulation: Heart Failure · doi:10.1161/circheartfailure.119.006720 · Cited by 29 · see citing works
Investigator-Reported Bleeding Versus Post Hoc Adjudication of Bleeding
Jatene, T., Harrington, R. A., Stone, G. W., Steg, P. G., Gibson, C. M., Hamm, C. W., Price, M. J., Prats, J., Deliargyris, E., Mahaffey, K. W., et al. (2016) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2015.11.027 · Cited by 26 · see citing works
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Gaudino, M. F. L., Arvind, V., Hameed, I., Franco, A. D., Spadaccio, C., Bhatt, D. L., & Bagiella, E. (2020) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2020.07.051 · Cited by 24 · see citing works
Self-citationBhatt, D. L., Eagle, K. A., & Ohman, E. M. (2011) · Journal of Vascular Surgery · doi:10.1016/j.jvs.2010.12.013 · Cited by 23 · see citing works
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Landgraf, R., Aberle, J., Birkenfeld, A. L., Gallwitz, B., Kellerer, M., Klein, H., Müller-Wieland, D., Nauck, M. A., Wiesner, T., & Siegel, E. (2022) · Experimental and Clinical Endocrinology & Diabetes · doi:10.1055/a-1624-3449 · Cited by 12 · see citing works
Kani, R., Miyamoto, Y., Saito, T., Watanabe, A., Matsubara, K., Ejiri, K., Iwagami, M., Slipczuk, L., Hosseini, K., Fujisaki, T., et al. (2025) · International Journal of Cardiology · doi:10.1016/j.ijcard.2025.133079 · Cited by 10 · see citing works
- Authors
- Bhatt, D. L., Szarek, M., Pitt, B., Cannon, C. P., Leiter, L. A., McGuire, D. K., Lewis, J. B., Riddle, M. C., Inzucchi, S. E., Kosiborod, M. N., Cherney, D. Z. I., Dwyer, J. P., Scirica, B. M., Bailey, C. J., Díaz, R., Ray, K. K., Udell, J. A., Lopes, R. D., Lapuerta, P., & Steg, P. G.
- Affiliations
- Brigham and Women's Hospital (US)
- From Brigham and Women’s Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and...
- ORCID
- Bhatt, Deepak L.
- Szarek, Michael
- Pitt, Bertram
- Cannon, Christopher P.
- Leiter, Lawrence A.
- McGuire, Darren K.
- Lewis, Julia B.
- Riddle, Matthew C.
- Inzucchi, Silvio E.
- Kosiborod, Mikhail N.
- Cherney, David Z.I.
- Dwyer, Jamie P.
- Scirica, Benjamin M.
- Bailey, Clifford J.
- Díaz, Rafael
- Ray, Kausik K.
- Udell, Jacob A.
- Lapuerta, Pablo
- Steg, P. Gabriel
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2021-01-14
- Volume
- 384
- Issue
- 2
- Pages
- 129-139
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W3101044784
- Cited by
- 1,205
- References
- 50
- Citations by year
- 2026: 121 · 2025: 155 · 2024: 220 · 2023: 242 · 2022: 232 · 2021: 222 · 2020: 10 · 2019: 1
- FWCI
- 132.61
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Aston Publications Explorer (Aston University) (acceptedVersion)
- Cineca Institutional Research Information System (Tor Vergata University) (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
- Spiral (Imperial College London) (submittedVersion)
- Funders
- Sanofi
- Lexicon
- 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
- sotagliflozin, SGLT2 inhibitors, diabetes mellitus, chronic kidney disease, albuminuria, cardiovascular events, heart failure hospitalization, cardiovascular mortality, drug safety, diarrhea, genital mycotic infections, diabetic ketoacidosis, hypovolemia, early trial termination, cardiovascular risk reduction, drug-drug interactions
- MeSH terms
- Sodium-Glucose Transporter 2 Inhibitors, Aged, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Diarrhea, Double-Blind Method, Female, Glycosides, Hospitalization, Humans, Male, Middle Aged, Mycoses, Diabetic Ketoacidosis, Sodium-Glucose Transporter 1, Renal Insufficiency, Chronic
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