Abstract | BACKGROUND: METHODS: 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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Authors | Deepak L Bhatt, Michael Szarek, Bertram Pitt, Christopher P Cannon, Lawrence A Leiter, Darren K McGuire, Julia B Lewis, Matthew C Riddle, Silvio E Inzucchi, Mikhail N Kosiborod, David Z I Cherney, Jamie P Dwyer, Benjamin M Scirica, Clifford J Bailey, Rafael Díaz, Kausik K Ray, Jacob A Udell, Renato D Lopes, Pablo Lapuerta, P Gabriel Steg, SCORED Investigators |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 384
Issue 2
Pg. 129-139
(01 14 2021)
ISSN: 1533-4406 [Electronic] United States |
PMID | 33200891
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2020 Massachusetts Medical Society. |
Chemical References |
- Glycosides
- Sodium-Glucose Transporter 1
- Sodium-Glucose Transporter 2 Inhibitors
- (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
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Topics |
- Aged
- Cardiovascular Diseases
(epidemiology, mortality)
- Diabetes Mellitus, Type 2
(complications, drug therapy)
- Diabetic Ketoacidosis
(chemically induced)
- Diarrhea
(chemically induced)
- Double-Blind Method
- Female
- Glycosides
(adverse effects, therapeutic use)
- Hospitalization
(statistics & numerical data)
- Humans
- Male
- Middle Aged
- Mycoses
(etiology)
- Renal Insufficiency, Chronic
(complications, drug therapy)
- Sodium-Glucose Transporter 1
(antagonists & inhibitors)
- Sodium-Glucose Transporter 2 Inhibitors
(adverse effects, therapeutic use)
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