1. Effect of ertugliflozin on left ventricular function in type 2 diabetes and pre-heart failure: the Ertu-GLS randomized clinical trial.
- Author
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Lim S, Bae JH, Oh H, Hwang IC, Yoon YE, and Cho GY
- Subjects
- Humans, Male, Female, Middle Aged, Aged, Double-Blind Method, Treatment Outcome, Time Factors, Ventricular Dysfunction, Left physiopathology, Ventricular Dysfunction, Left drug therapy, Ventricular Dysfunction, Left diagnosis, Biomarkers blood, Recovery of Function, Angiotensin-Converting Enzyme 2 metabolism, Hypertrophy, Left Ventricular physiopathology, Hypertrophy, Left Ventricular drug therapy, Hypertrophy, Left Ventricular diagnostic imaging, Heart Failure drug therapy, Heart Failure physiopathology, Heart Failure diagnosis, Blood Glucose drug effects, Blood Glucose metabolism, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 diagnosis, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 physiopathology, Diabetes Mellitus, Type 2 complications, Sodium-Glucose Transporter 2 Inhibitors therapeutic use, Sodium-Glucose Transporter 2 Inhibitors adverse effects, Ventricular Function, Left drug effects, Bridged Bicyclo Compounds, Heterocyclic therapeutic use, Bridged Bicyclo Compounds, Heterocyclic adverse effects, Stroke Volume drug effects
- Abstract
Background: The therapeutic effects of ertugliflozin, a sodium-glucose cotransporter 2 inhibitor, on cardiovascular outcome are not fully understood. This study aimed to evaluate the efficacy and safety of ertugliflozin on cardiac function in people with type 2 diabetes and pre-heart failure., Methods: We conducted a 24-week randomized, double-blind, placebo-controlled trial involving individuals with type 2 diabetes inadequately controlled with antidiabetic medications. Participants with left ventricular hypertrophy, E/e' >15, or impaired left ventricular global longitudinal strain (LVGLS) were randomized 1:1 to receive either ertugliflozin (5 mg once daily) or a placebo. The primary outcome was the change in LVGLS. Secondary outcomes included changes in left ventricular mass index (LVMI) and left ventricular ejection fraction (LVEF). Prespecified exploratory outcomes, including angiotensin-converting enzyme 2 (ACE2) and angiotensin (1-7) levels, were also assessed., Results: A total of 102 individuals (mean age, 63.9 ± 9.2 years; 38% women) were included. The ertugliflozin group showed a significant improvement in LVGLS (- 15.5 ± 3.1% to - 16.6 ± 2.8%, P = 0.004) compared to the placebo group (- 16.7 ± 2.7% to - 16.4 ± 2.6%, P = 0.509), with a significant between-group difference (P = 0.013). Improvements in LVMI and LVEF were also observed. Additionally, significant reductions in HbA
1c , systolic blood pressure, whole-body and visceral fat, uric acid, proteinuria, N-terminal pro-B-type natriuretic peptide, and lipoprotein(a) were noted. ACE2 and angiotensin (1-7) levels significantly increased in the ertugliflozin group compared to the placebo group and correlated with changes in LVGLS [r = 0.456, P < 0.001 for ACE2; r = 0.541, P < 0.001 for angiotensin (1-7)]. Adverse events were similar between the two groups., Conclusions: This study demonstrated that ertugliflozin has beneficial effects on left ventricular function in individuals with type 2 diabetes and pre-heart failure, and it provided insights into potential underlying mechanisms., Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT03717194., (© 2024. The Author(s).)- Published
- 2024
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