Forskning
Udskriv Udskriv
Switch language
Region Hovedstaden - en del af Københavns Universitetshospital
Udgivet

Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

  1. Lower or Higher Oxygenation Targets for Acute Hypoxemic Respiratory Failure

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Monoclonal Antibody for Patients with Covid-19. Reply

    Publikation: Bidrag til tidsskriftLetterpeer review

  4. A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  5. Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  1. Prognosis of myocardial infarction-related cardiogenic shock according to preadmission out-of-hospital cardiac arrest

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Cardiovascular comorbidities as predictors for severe COVID-19 infection or death

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  • SCORED Investigators
  • Morten Schou (Medlem af forfattergruppering)
Vis graf over relationer

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.

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.).

OriginalsprogEngelsk
TidsskriftThe New England journal of medicine
Vol/bind384
Udgave nummer2
Sider (fra-til)129-139
Antal sider11
ISSN0028-4793
DOI
StatusUdgivet - 14 jan. 2021

Bibliografisk note

Copyright © 2020 Massachusetts Medical Society.

ID: 62030729