Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease
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| Title: | Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease |
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| Authors: | 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, Lopes, Renato D, Lapuerta, Pablo, Steg, P Gabriel, Lauro d |
| Contributors: | Bhatt, Dl, Szarek, M, Pitt, B, Cannon, Cp, Leiter, La, Mcguire, Dk, Lewis, Jb, Riddle, Mc, Inzucchi, Se, Kosiborod, Mn, Cherney, Dzi, Dwyer, Jp, Scirica, Bm, Bailey, Cj, Díaz, R, Ray, Kk, Udell, Ja, Lopes, Rd, Lapuerta, P, Steg, P, G, Lauro, D |
| Source: | NEW ENGLAND JOURNAL OF MEDICINE r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA instname 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 & SCORED Investigators 2021, 'Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease', The New England Journal of Medicine, vol. 384, no. 2, pp. 129-139. https://doi.org/10.1056/NEJMoa2030186 |
| Publisher Information: | Massachusetts Medical Society, 2021. |
| Publication Year: | 2021 |
| Subject Terms: | Male, SAXAGLIPTIN, MELLITUS, 0302 clinical medicine, Renal Insufficiency, Glycosides, Chronic, 11 Medical and Health Sciences, RISK, SGLT2 INHIBITOR, OUTCOMES, EMPAGLIFLOZIN, Middle Aged, 3. Good health, Hospitalization, Cardiovascular Diseases, Medicine, HEART-FAILURE, Diarrhea/chemically induced, Female, OUTPATIENTS, Life Sciences & Biomedicine, Type 2, Diarrhea, Mycoses/etiology, SCORED Investigators, Renal Insufficiency, Chronic/complications, General & Internal, Glycosides/adverse effects, Diabetic Ketoacidosis, 03 medical and health sciences, Medicine, General & Internal, Sodium-Glucose Transporter 1, Double-Blind Method, General & Internal Medicine, Diabetes Mellitus, Humans, Renal Insufficiency, Chronic, Sodium-Glucose Transporter 2 Inhibitors, Hospitalization/statistics & numerical data, Aged, Science & Technology, Diabetic Ketoacidosis/chemically induced, Cardiovascular Diseases/epidemiology, Diabetes Mellitus, Type 2/complications, MORTALITY, Sodium-Glucose Transporter 2 Inhibitors/adverse effects, Settore MED/13 - ENDOCRINOLOGIA, CARDIOVASCULAR EVENT RATES, Sodium-Glucose Transporter 1/antagonists & inhibitors, Diabetes Mellitus, Type 2, Mycoses |
| Description: | 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.We conducted a multicenter, double-blind trial in which patients with type 2 diabetes mellitus (glycated hemoglobin level, ≥7%), chronic kidney disease (estimated glomerular filtration rate, 25 to 60 ml per minute per 1.73 m2 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.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 |
| Document Type: | Article |
| File Description: | application/pdf |
| Language: | English |
| ISSN: | 1533-4406 0028-4793 |
| DOI: | 10.1056/nejmoa2030186 |
| Access URL: | https://pubmed.ncbi.nlm.nih.gov/33200891 https://www.fundanet.incliva.es/publicaciones/ProdCientif/PublicacionFrw.aspx?id=16116 https://incliva.fundanetsuite.com/publicaciones/ProdCientif/PublicacionFrw.aspx?id=16116 https://publications.aston.ac.uk/id/eprint/42285/1/nejmoa2030186.pdf https://spiral.imperial.ac.uk/handle/10044/1/84257 https://research.aston.ac.uk/en/publications/sotagliflozin-in-patients-with-diabetes-and-chronic-kidney-diseas http://europepmc.org/abstract/MED/33200891 https://pubmed.ncbi.nlm.nih.gov/33200891/ https://utsouthwestern.pure.elsevier.com/en/publications/sotagliflozin-in-patients-with-diabetes-and-chronic-kidney-diseas https://www.nejm.org/doi/suppl/10.1056/NEJMoa2030186/suppl_file/nejmoa2030186_appendix.pdf http://hdl.handle.net/10044/1/84257 https://pure.au.dk/portal/en/publications/6bc50c6b-8a7a-4eea-bd9e-9032680e8b64 https://pure.au.dk/portal/en/publications/6bc50c6b-8a7a-4eea-bd9e-9032680e8b64 https://doi.org/10.1056/NEJMoa2030186 https://pure.au.dk/ws/files/275345883/Sotagliflozin_in_Patients_with_Diabetes_and_Chronic_Kidney_Disease.pdf |
| Rights: | URL: http://www.nejmgroup.org/legal/terms-of-use.htm |
| Accession Number: | edsair.doi.dedup.....5e9705eeadc025b1e0478507d16cdaa4 |
| Database: | OpenAIRE |
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Nájsť tento článok vo Web of Science | Abstract: | 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.We conducted a multicenter, double-blind trial in which patients with type 2 diabetes mellitus (glycated hemoglobin level, ≥7%), chronic kidney disease (estimated glomerular filtration rate, 25 to 60 ml per minute per 1.73 m2 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.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 |
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| ISSN: | 15334406 00284793 |
| DOI: | 10.1056/nejmoa2030186 |