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15. Cardiovascular Outcomes with Ertugliflozin in Type 2 Diabetes

Author

Cannon, Cp, Pratley, R, Dagogo-Jack, S, Mancuso, J, Huyck, S, Masiukiewicz, U, Charbonnel, B, Frederich, R, Gallo, S, Cosentino, F, Shih, Wj, Gantz, I, Terra, Sg, Cherney, Dzi, Mcguire, Dk, VERTIS CV Investigators, Pugliese, G, Lembo, G, Cannon, C. P., Pratley, R., Dagogo-Jack, S., Mancuso, J., Huyck, S., Masiukiewicz, U., Charbonnel, B., Frederich, R., Gallo, S., Cosentino, F., Shih, W. J., Paolisso, G, Gantz, I., Terra, S. G., Cherney, D. Z. I., and Mcguire, D. K.

Subjects
Male, medicine.medical_specialty, ertugliflozin, MEDLINE, type 2 diabetes, cardiovascular disease, Type 2 diabetes, 030204 cardiovascular system & hematology, law.invention, Placebos, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, Internal medicine, Diabetes mellitus, Humans, Medicine, Diabetic Nephropathies, 030212 general & internal medicine, Sodium-Glucose Transporter 2 Inhibitors, Placebo, Aged, urogenital system, business.industry, General Medicine, Middle Aged, Atherosclerosis, medicine.disease, Bridged Bicyclo Compounds, Heterocyclic, Hospitalization, Equivalence Trial, Multicenter study, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Atherosclerosi, Diabetic Nephropathie, Ertugliflozin, Female, business, Cardiovascular outcomes, Human
Abstract

The cardiovascular effects of ertugliflozin, an inhibitor of sodium-glucose cotransporter 2, have not been established.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.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; P0.001 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.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 SharpDohme and Pfizer; VERTIS CV ClinicalTrials.gov number, NCT01986881.).

Published
2020

21. POS-354 WORSENING KIDNEY DISEASE INFLUENCES THE EFFICACY OF ERTUGLIFLOZIN ON GLUCOSURIA-MEDIATED ENDPOINTS BUT DOES NOT INFLUENCE THE EFFICACY ON NATRIURESIS-RELATED ENDPOINTS: PRESPECIFIED ANALYSES FROM VERTIS CV

Author

Cherney, D., primary, Charbonnel, B., additional, Cosentino, F., additional, Pratley, R.E., additional, Dagogo-Jack, S., additional, Shih, W.J., additional, McGuire, D.K., additional, Frederich, R., additional, Maldonado, M., additional, Liu, J., additional, Pong, A., additional, Liu, C., additional, and Cannon, C.P., additional

Published
2021
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39. Competing Perspectives on PROactive

Author

Dormandy, J., Charbonnel, B., Erdmann, E., Massi-Benedetti, M., Moules, I., Skene, A., Tan, M., Lefèbvre, P., Murray, G., Standl, E., Wilhelmsen, L., Wilcox, R., and Yates, John

Published
2007

50. Effect of acetate and propionate on fasting hepatic glucose production in humans

Author

Laurent, C, Simoneau, C, Marks, L, Braschi, S, Champ, M, Charbonnel, B, and Krempf, M

Subjects
Fatty acids -- Physiological aspects, Glucose -- Synthesis
Abstract

A study to determine the effect of short chain fatty acids on the production of glucose by the liver found that propionate decreases hepatic glucose production by inhibiting neoglucogenesis and increasing glycolysis while acetate in the absence of propionate increases hepatic glucose production. The concentration of blood glucose and plasma insulin were unaffected by treatment with propionate alone or propionate with acetate. However, the increase in free fatty acid plasma concentration which is associated with the fasting state was inhibited by the presence of these compounds.

Published
1995

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