Cardiovascular Outcomes with Ertugliflozin in Type 2 Diabetes.
By C. Cannon, R. Pratley, S. Dagogo-Jack, J. Mancuso, S. Huyck, Urszula Masiukiewicz, B. Charbonnel, R. Frederich, Silvina Gallo, F. Cosentino and 5 more. New England Journal of Medicine, 2020
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BACKGROUND The cardiovascular effects of ertugliflozin, an inhibitor of sodium-glucose cotransporter 2, have not been established. METHODS In a multicenter, double-blind trial, we randomly assigned patients with type 2 diabetes and atherosclerotic cardiovascular disease to receive 5 mg or 15 mg of ertugliflozin or placebo once daily. With the data from the two ertugliflozin dose groups pooled for analysis, the primary objective was to show the noninferiority of ertugliflozin to placebo with respect to the primary outcome, major adverse cardiovascular events (a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke). The noninferiority margin was 1.3 (upper boundary of a 95.6% confidence interval for the hazard ratio [ertugliflozin vs. placebo] for major adverse cardiovascular events). The first key secondary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure. RESULTS A total of 8246 patients underwent randomization and were followed for a mean of 3.5 years. Among 8238 patients who received at least one dose of ertugliflozin or placebo, a major adverse cardiovascular event occurred in 653 of 5493 patients (11.9%) in the ertugliflozin group and in 327 of 2745 patients (11.9%) in the placebo group (hazard ratio, 0.97; 95.6% confidence interval [CI], 0.85 to 1.11; P<0.001 for noninferiority). Death from cardiovascular causes or hospitalization for heart failure occurred in 444 of 5499 patients (8.1%) in the ertugliflozin group and in 250 of 2747 patients (9.1%) in the placebo group (hazard ratio, 0.88; 95.8% CI, 0.75 to 1.03; P = 0.11 for superiority). The hazard ratio for death from cardiovascular causes was 0.92 (95.8% CI, 0.77 to 1.11), and the hazard ratio for death from renal causes, renal replacement therapy, or doubling of the serum creatinine level was 0.81 (95.8% CI, 0.63 to 1.04). Amputations were performed in 54 patients (2.0%) who received the 5-mg dose of ertugliflozin and in 57 patients (2.1%) who received the 15-mg dose, as compared with 45 patients (1.6%) who received placebo. CONCLUSIONS Among patients with type 2 diabetes and atherosclerotic cardiovascular disease, ertugliflozin was noninferior to placebo with respect to major adverse cardiovascular events. (Funded by Merck Sharp & Dohme and Pfizer; VERTIS CV ClinicalTrials.gov number, NCT01986881.).
Subfields: Endocrinology, Diabetes and Metabolism
View Paper: https://www.semanticscholar.org/paper/b9d077e8b56f269b62c0000bba2ee4d667349d48
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In Endocrinology, Diabetes and Metabolism
Citations in the corpus
- Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). (2022, methodology): “Pairwise meta-analyses of SGLT2i CVOTs verified that SGLT2i reduced MACE, HHF, and a composite kidney outcome in the overall population versus placebo (142,249).”
- Management of hyperglycaemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) (2022, positive): “Sotagliflozin reduced the composite endpoint of cardiovascular mortality, HHF or urgent visits for HF compared with placebo, but had no effect on the composite kidney endpoint.”
- Inflammation and atherosclerosis: signaling pathways and therapeutic intervention (2022, result): “Ertugliflozin was demonstrated the noninferiority versus placebo on MACE in patients with atherosclerotic cardiovascular disease and T2DM.(334) Dapagliflozin treatment did not lead to lower or higher MACE compared to placebo in T2DM patients at risk for atherosclerotic cardiovascular disease rate bu”