Effect of Empagliflozin on Left Ventricular Mass in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease

Autor: Adrian Quan, David Fitchett, Fei Zuo, Lawrence A. Leiter, Bernard Zinman, Shaun G. Goodman, Mohammed Al-Omran, Ronald Goldenberg, Vinay Garg, Tamique Mason, Peter Jüni, Andrew T. Yan, Deepak L. Bhatt, Hwee Teoh, C. David Mazer, Richard E. Gilbert, Subodh Verma, Michael E. Farkouh, Kim A. Connelly
Rok vydání: 2019
Předmět:
Adult
Male
medicine.medical_specialty
Time Factors
Diabetic Cardiomyopathies
Magnetic Resonance Imaging
Cine
030209 endocrinology & metabolism
Coronary Artery Disease
030204 cardiovascular system & hematology
Ventricular Function
Left
law.invention
Left ventricular mass
Coronary artery disease
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Double-Blind Method
Glucosides
Randomized controlled trial
law
Physiology (medical)
Internal medicine
Diabetes mellitus
Empagliflozin
medicine
Humans
In patient
Benzhydryl Compounds
Sodium-Glucose Transporter 2 Inhibitors
Aged
Aged
80 and over
Ontario
Ventricular Remodeling
business.industry
Type 2 Diabetes Mellitus
Middle Aged
medicine.disease
Treatment Outcome
Diabetes Mellitus
Type 2
chemistry
Cardiology
Female
Cardiology and Cardiovascular Medicine
business
EMPA
Zdroj: Circulation. 140:1693-1702
ISSN: 1524-4539
0009-7322
DOI: 10.1161/circulationaha.119.042375
Popis: Background: SGLT2 (sodium-glucose cotransporter 2) inhibitors lower cardiovascular events in type 2 diabetes mellitus but whether they promote direct cardiac effects remains unknown. We sought to determine if empagliflozin causes a decrease in left ventricular (LV) mass in people with type 2 diabetes mellitus and coronary artery disease. Methods: Between November 2016 and April 2018, we recruited 97 individuals ≥40 and ≤80 years old with glycated hemoglobin 6.5% to 10.0%, known coronary artery disease, and estimated glomerular filtration rate ≥60mL/min/1.73m 2 . The participants were randomized to empagliflozin (10 mg/day, n=49) or placebo (n=48) for 6 months, in addition to standard of care. The primary outcome was the 6-month change in LV mass indexed to body surface area from baseline as measured by cardiac magnetic resonance imaging. Other measures included 6-month changes in LV end-diastolic and -systolic volumes indexed to body surface area, ejection fraction, 24-hour ambulatory blood pressure, hematocrit, and NT-proBNP (N-terminal pro b-type natriuretic peptide). Results: Among the 97 participants (90 men [93%], mean [standard deviation] age 62.8 [9.0] years, type 2 diabetes mellitus duration 11.0 [8.2] years, estimated glomerular filtration rate 88.4 [16.9] mL/min/1.73m 2 , LV mass indexed to body surface area 60.7 [11.9] g/m 2 ), 90 had evaluable imaging at follow-up. Mean LV mass indexed to body surface area regression over 6 months was 2.6 g/m 2 and 0.01 g/m 2 for those assigned empagliflozin and placebo, respectively (adjusted difference −3.35 g/m 2 ; 95% CI, −5.9 to −0.81g/m 2 , P =0.01). In the empagliflozin-allocated group, there was significant lowering of overall ambulatory systolic blood pressure (adjusted difference −6.8mmHg, 95% CI −11.2 to −2.3mmHg, P =0.003), diastolic blood pressure (adjusted difference −3.2mmHg; 95% CI, −5.8 to −0.6mmHg, P =0.02) and elevation of hematocrit ( P =0.0003). Conclusions: Among people with type 2 diabetes mellitus and coronary artery disease, SGLT2 inhibition with empagliflozin was associated with significant reduction in LV mass indexed to body surface area after 6 months, which may account in part for the beneficial cardiovascular outcomes observed in the EMPA-REG OUTCOME (BI 10773 [Empagliflozin] Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) trial. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02998970.
Databáze: OpenAIRE
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