Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease.
Por:
Bhatt D, Szarek M, Pitt B, Cannon C, Leiter L, McGuire D, Lewis J, Riddle M, Inzucchi S, Kosiborod M, Cherney D, Dwyer J, Scirica B, Bailey C, Diaz R, Ray K, Udell J, Lopes R, Lapuerta P, Steg P, SCORED Investigators, SCORED Investigators
Publicada:
14 ene 2021
Ahead of Print:
16 nov 2020
Resumen:
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 m(2) 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.).
Filiaciones:
Bhatt D:
Brigham & Womens Hosp, Heart & Vasc Ctr, 75 Francis St, Boston, MA 02115 USA
Harvard Med Sch, 75 Francis St, Boston, MA 02115 USA
Szarek M:
Univ Colorado Anschutz Med Campus, Colorado Prevent Ctr Clin Res, Aurora, CO USA
Univ Colorado Anschutz Med Campus, Dept Med, Div Cardiovasc Med, Aurora, CO USA
State Univ New York Downstate, Sch Publ Hlth, Brooklyn, NY USA
Pitt B:
Univ Michigan, Ann Arbor, MI 48109 USA
Cannon C:
Brigham & Womens Hosp, Heart & Vasc Ctr, 75 Francis St, Boston, MA 02115 USA
Harvard Med Sch, 75 Francis St, Boston, MA 02115 USA
Leiter L:
St Michaels Hosp, Li Ka Shing Knowledge Inst, Toronto, ON, Canada
St Michaels Hosp, Div Endocrinol & Metab, Toronto, ON, Canada
Univ Toronto, Dept Med, Toronto, ON, Canada
Univ Toronto, Dept Nutr Sci, Toronto, ON, Canada
McGuire D:
Univ Texas Southwestern Med Ctr Dallas, Dallas, TX 75390 USA
Parkland Hlth & Hosp Syst, Dallas, TX USA
Lewis J:
Vanderbilt Univ, Med Ctr, Nashville, TN USA
Riddle M:
Oregon Hlth & Sci Univ, Div Endocrinol Diabet & Clin Nutr, Portland, OR 97201 USA
Inzucchi S:
Yale Sch Med, Endocrinol Sect, New Haven, CT USA
Kosiborod M:
Univ Missouri, St Lukes Mid Amer Heart Inst, Columbia, MO 65211 USA
Cherney D:
Univ Toronto, Womens Coll Hosp, Div Nephrol, Univ Hlth Network, Toronto, ON, Canada
Dwyer J:
Vanderbilt Univ, Med Ctr, Nashville, TN USA
Scirica B:
Brigham & Womens Hosp, Heart & Vasc Ctr, 75 Francis St, Boston, MA 02115 USA
Harvard Med Sch, 75 Francis St, Boston, MA 02115 USA
Bailey C:
Aston Univ, Sch Life & Hlth Sci, Birmingham B4 7ET, W Midlands, England
Diaz R:
Inst Cardiovasc Rosario, Estudios Clin Latinoamer, Dept Med, Rosario, Argentina
Ray K:
Imperial Coll London, Dept Primary Care & Publ Hlth, Imperial Ctr Cardiovasc Dis Prevent, London, England
Udell J:
Univ Toronto, Peter Munk Cardiac Ctr, Womens Coll Hosp, Toronto, ON, Canada
Lopes R:
Duke Univ, Sch Med, Duke Clin Res Inst, Durham, NC USA
Lapuerta P:
Lexicon Pharmaceut, The Woodlands, TX USA
Steg P:
Univ Paris, French Alliance Cardiovasc Trials, Hop Bichat, AP HP,INSERM Unite 1148, Paris, France
SCORED Investigators:
SCORED Investigators
SCORED Investigators:
SCORED Investigators
Green Published, Bronze, Green Accepted
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