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Effect of Empagliflozin on Left Ventricular Mass in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease: The EMPA-HEART CardioLink-6 Randomized Clinical Trial

Circulation (New York, N.Y.), 2019-11, Vol.140 (21), p.1693-1702 [Peer Reviewed Journal]

2019 by the American College of Cardiology Foundation and the American Heart Association, Inc. ;ISSN: 0009-7322 ;EISSN: 1524-4539 ;DOI: 10.1161/CIRCULATIONAHA.119.042375

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  • Title:
    Effect of Empagliflozin on Left Ventricular Mass in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease: The EMPA-HEART CardioLink-6 Randomized Clinical Trial
  • Author: Verma, Subodh ; Mazer, C David ; Yan, Andrew T ; Mason, Tamique ; Garg, Vinay ; Teoh, Hwee ; Zuo, Fei ; Quan, Adrian ; Farkouh, Michael E ; Fitchett, David H ; Goodman, Shaun G ; Goldenberg, Ronald M ; Al-Omran, Mohammed ; Gilbert, Richard E ; Bhatt, Deepak L ; Leiter, Lawrence A ; Jüni, Peter ; Zinman, Bernard ; Connelly, Kim A
  • Is Part Of: Circulation (New York, N.Y.), 2019-11, Vol.140 (21), p.1693-1702
  • Description: 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. 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, LV mass indexed to body surface area 60.7 [11.9] g/m), 90 had evaluable imaging at follow-up. Mean LV mass indexed to body surface area regression over 6 months was 2.6 g/m and 0.01 g/m for those assigned empagliflozin and placebo, respectively (adjusted difference −3.35 g/m; 95% CI, −5.9 to −0.81g/m, 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:URLhttps://www.clinicaltrials.gov. Unique identifierNCT02998970.
  • Publisher: by the American College of Cardiology Foundation and the American Heart Association, Inc
  • Language: English
  • Identifier: ISSN: 0009-7322
    EISSN: 1524-4539
    DOI: 10.1161/CIRCULATIONAHA.119.042375
  • Source: Geneva Foundation Free Medical Journals at publisher websites
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