1. Effect of Empagliflozin on Left Ventricular Volumes in Patients With Type 2 Diabetes, or Prediabetes, and Heart Failure With Reduced Ejection Fraction (SUGAR-DM-HF)
- Author
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Vera Lennie, Aleksandra Radjenovic, Victor Chong, Kirsty Wetherall, Steven Sourbron, Naveed Sattar, Colin J. Petrie, Liz Coyle, Catherine Labinjoh, Katriona Brooksbank, Giles Roditi, John J.V. McMurray, Matthew M.Y. Lee, Rosemary Woodward, John R. Petrie, Iain A. Speirits, John G. Dreisbach, Clare Murphy, Pardeep S. Jhund, Kieran F. Docherty, Colin Berry, Alex McConnachie, Paul Welsh, Kenneth Mangion, Patrick B. Mark, Ross T. Campbell, Mark C. Petrie, and Ninian N. Lang
- Subjects
Male ,medicine.medical_specialty ,Type 2 diabetes ,030204 cardiovascular system & hematology ,Prediabetic State ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,Glucosides ,Physiology (medical) ,Internal medicine ,Diabetes mellitus ,medicine ,Empagliflozin ,Humans ,030212 general & internal medicine ,Prediabetes ,Benzhydryl Compounds ,Ventricular remodeling ,Sodium-Glucose Transporter 2 Inhibitors ,Aged ,Heart Failure ,Ejection fraction ,medicine.diagnostic_test ,Ventricular Remodeling ,business.industry ,Magnetic resonance imaging ,Stroke Volume ,medicine.disease ,Diabetes Mellitus, Type 2 ,Heart failure ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background: Sodium-glucose cotransporter 2 inhibitors reduce the risk of heart failure hospitalization and cardiovascular death in patients with heart failure and reduced ejection fraction (HFrEF). However, their effects on cardiac structure and function in HFrEF are uncertain. Methods: We designed a multicenter, randomized, double-blind, placebo-controlled trial (the SUGAR-DM-HF trial [Studies of Empagliflozin and Its Cardiovascular, Renal and Metabolic Effects in Patients With Diabetes Mellitus, or Prediabetes, and Heart Failure]) to investigate the cardiac effects of empagliflozin in patients in New York Heart Association functional class II to IV with a left ventricular (LV) ejection fraction ≤40% and type 2 diabetes or prediabetes. Patients were randomly assigned 1:1 to empagliflozin 10 mg once daily or placebo, stratified by age ( Results: From April 2018 to August 2019, 105 patients were randomly assigned: mean age 68.7 (SD, 11.1) years, 77 (73.3%) male, 82 (78.1%) diabetes and 23 (21.9%) prediabetes, mean LV ejection fraction 32.5% (9.8%), and 81 (77.1%) New York Heart Association II and 24 (22.9%) New York Heart Association III. Patients received standard treatment for HFrEF. In comparison with placebo, empagliflozin reduced LV end-systolic volume index by 6.0 (95% CI, –10.8 to –1.2) mL/m 2 ( P =0.015). There was no difference in LV global longitudinal strain. Empagliflozin reduced LV end-diastolic volume index by 8.2 (95% CI, –13.7 to –2.6) mL/m 2 ( P =0.0042) and reduced N-terminal pro-B-type natriuretic peptide by 28% (2%–47%), P =0.038. There were no between-group differences in other cardiovascular magnetic resonance measures, diuretic intensification, Kansas City Cardiomyopathy Questionnaire Total Symptom Score, 6-minute walk distance, or B-lines. Conclusions: The sodium-glucose cotransporter 2 inhibitor empagliflozin reduced LV volumes in patients with HFrEF and type 2 diabetes or prediabetes. Favorable reverse LV remodeling may be a mechanism by which sodium-glucose cotransporter 2 inhibitors reduce heart failure hospitalization and mortality in HFrEF. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03485092.
- Published
- 2021
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