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Cardiovascular Outcomes with Ertugliflozin in Type 2 Diabetes
- Publication Year :
- 2020
- Publisher :
- Massachussetts Medical Society, 2020.
-
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.).
- 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
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Accession number :
- edsair.doi.dedup.....72aa603a4087e3dbb406ccd3293c631f