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@article{Bhatt:2021:10.1056/NEJMoa2030186,
author = {Bhatt, DL and Szarek, M and Pitt, B and Cannon, CP and Leiter, LA and McGuire, DK and Lewis, JB and Riddle, MC and Inzucchi, SE and Kosiborod, MN and Cherney, DZI and Dwyer, JP and Scirica, BM and Bailey, CJ and Díaz, R and Ray, KK and Udell, JA and Lopes, RD and Lapuerta, P and Steg, PG and SCORED, Investigators},
doi = {10.1056/NEJMoa2030186},
journal = {New England Journal of Medicine},
pages = {129--139},
title = {Sotagliflozin in patients with diabetes and chronic kidney disease.},
url = {http://dx.doi.org/10.1056/NEJMoa2030186},
volume = {384},
year = {2021}
}

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TY  - JOUR
AB  - 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: 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. 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. CO
AU  - Bhatt,DL
AU  - Szarek,M
AU  - Pitt,B
AU  - Cannon,CP
AU  - Leiter,LA
AU  - McGuire,DK
AU  - Lewis,JB
AU  - Riddle,MC
AU  - Inzucchi,SE
AU  - Kosiborod,MN
AU  - Cherney,DZI
AU  - Dwyer,JP
AU  - Scirica,BM
AU  - Bailey,CJ
AU  - Díaz,R
AU  - Ray,KK
AU  - Udell,JA
AU  - Lopes,RD
AU  - Lapuerta,P
AU  - Steg,PG
AU  - SCORED,Investigators
DO  - 10.1056/NEJMoa2030186
EP  - 139
PY  - 2021///
SN  - 0028-4793
SP  - 129
TI  - Sotagliflozin in patients with diabetes and chronic kidney disease.
T2  - New England Journal of Medicine
UR  - http://dx.doi.org/10.1056/NEJMoa2030186
UR  - https://www.ncbi.nlm.nih.gov/pubmed/33200891
UR  - https://www.nejm.org/doi/10.1056/NEJMoa2030186
UR  - http://hdl.handle.net/10044/1/84257
VL  - 384
ER  -

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