Randomized Trial of Empagliflozin in Nondiabetic Patients With Heart Failure and Reduced Ejection Fraction.
| Autor: | Santos-Gallego CG; Cardiology Department, Cardiovascular Institute, Mount Sinai Hospital, New York, New York, USA; AtheroThrombosis Research Unit, Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA., Vargas-Delgado AP; Cardiology Department, Cardiovascular Institute, Mount Sinai Hospital, New York, New York, USA; AtheroThrombosis Research Unit, Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA., Requena-Ibanez JA; Cardiology Department, Cardiovascular Institute, Mount Sinai Hospital, New York, New York, USA; AtheroThrombosis Research Unit, Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA., Garcia-Ropero A; Cardiology Department, Cardiovascular Institute, Mount Sinai Hospital, New York, New York, USA; AtheroThrombosis Research Unit, Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA., Mancini D; Cardiology Department, Cardiovascular Institute, Mount Sinai Hospital, New York, New York, USA., Pinney S; Cardiology Department, Cardiovascular Institute, Mount Sinai Hospital, New York, New York, USA., Macaluso F; Cardiology Department, Cardiovascular Institute, Mount Sinai Hospital, New York, New York, USA., Sartori S; Cardiology Department, Cardiovascular Institute, Mount Sinai Hospital, New York, New York, USA., Roque M; Cardiology Department, Cardiovascular Institute, Mount Sinai Hospital, New York, New York, USA; AtheroThrombosis Research Unit, Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA., Sabatel-Perez F; Cardiology Department, Cardiovascular Institute, Mount Sinai Hospital, New York, New York, USA; AtheroThrombosis Research Unit, Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA., Rodriguez-Cordero A; Cardiology Department, Cardiovascular Institute, Mount Sinai Hospital, New York, New York, USA; AtheroThrombosis Research Unit, Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA., Zafar MU; Cardiology Department, Cardiovascular Institute, Mount Sinai Hospital, New York, New York, USA; AtheroThrombosis Research Unit, Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA., Fergus I; Cardiology Department, Cardiovascular Institute, Mount Sinai Hospital, New York, New York, USA., Atallah-Lajam F; Cardiology Department, Cardiovascular Institute, Mount Sinai Hospital, New York, New York, USA., Contreras JP; Cardiology Department, Cardiovascular Institute, Mount Sinai Hospital, New York, New York, USA., Varley C; Cardiology Department, Cardiovascular Institute, Mount Sinai Hospital, New York, New York, USA., Moreno PR; Cardiology Department, Cardiovascular Institute, Mount Sinai Hospital, New York, New York, USA., Abascal VM; Cardiology Department, Cardiovascular Institute, Mount Sinai Hospital, New York, New York, USA., Lala A; Cardiology Department, Cardiovascular Institute, Mount Sinai Hospital, New York, New York, USA., Tamler R; Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York, New York, USA., Sanz J; Cardiology Department, Cardiovascular Institute, Mount Sinai Hospital, New York, New York, USA., Fuster V; Cardiology Department, Cardiovascular Institute, Mount Sinai Hospital, New York, New York, USA; Centro Nacional de Investigaciones Cardiovasculares Carlos III, Madrid, Spain., Badimon JJ; Cardiology Department, Cardiovascular Institute, Mount Sinai Hospital, New York, New York, USA; AtheroThrombosis Research Unit, Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address: juan.badimon@mssm.edu. |
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| Jazyk: | angličtina |
| Zdroj: | Journal of the American College of Cardiology [J Am Coll Cardiol] 2021 Jan 26; Vol. 77 (3), pp. 243-255. Date of Electronic Publication: 2020 Nov 13. |
| DOI: | 10.1016/j.jacc.2020.11.008 |
| Abstrakt: | Background: Large clinical trials established the benefits of sodium-glucose cotransporter 2 inhibitors in patients with diabetes and with heart failure with reduced ejection fraction (HFrEF). The early and significant improvement in clinical outcomes is likely explained by effects beyond a reduction in hyperglycemia. Objectives: The purpose of this study was to assess the effect of empagliflozin on left ventricular (LV) function and volumes, functional capacity, and quality of life (QoL) in nondiabetic HFrEF patients. Methods: In this double-blind, placebo-controlled trial, nondiabetic HFrEF patients (n = 84) were randomized to empagliflozin 10 mg daily or placebo for 6 months. The primary endpoint was change in LV end-diastolic and -systolic volume assessed by cardiac magnetic resonance. Secondary endpoints included changes in LV mass, LV ejection fraction, peak oxygen consumption in the cardiopulmonary exercise test, 6-min walk test, and quality of life. Results: Empagliflozin was associated with a significant reduction of LV end-diastolic volume (-25.1 ± 26.0 ml vs. -1.5 ± 25.4 ml for empagliflozin vs. placebo, respectively; p < 0.001) and LV end-systolic volume (-26.6 ± 20.5 ml vs. -0.5 ± 21.9 ml for empagliflozin vs. placebo; p < 0.001). Empagliflozin was associated with reductions in LV mass (-17.8 ± 31.9 g vs. 4.1 ± 13.4 g, for empagliflozin vs. placebo, respectively; p < 0.001) and LV sphericity, and improvements in LV ejection fraction (6.0 ± 4.2 vs. -0.1 ± 3.9; p < 0.001). Patients who received empagliflozin had significant improvements in peak O Conclusions: Empagliflozin administration to nondiabetic HFrEF patients significantly improves LV volumes, LV mass, LV systolic function, functional capacity, and quality of life when compared with placebo. Our observations strongly support a role for sodium-glucose cotransporter 2 inhibitors in the treatment of HFrEF patients independently of their glycemic status. (Are the "Cardiac Benefits" of Empagliflozin Independent of Its Hypoglycemic Activity? [ATRU-4] [EMPA-TROPISM]; NCT03485222). Competing Interests: Author Disclosures This research was supported by an independent grant from Boehringer Ingelheim, who provided both drug and financial support for the study. Dr. Pinney has received consulting fees from Abbott, Medtronic, and Procryrion; and has received both consulting and speaking fees from Care Dx. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.) |
| Databáze: | MEDLINE |
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