Empagliflozin and Left Ventricular Remodeling in People Without Diabetes: Primary Results of the EMPA-HEART 2 CardioLink-7 Randomized Clinical Trial
Rattachement africain : ca, ie, tw, gb, us, sg, br. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
Background: Sodium-glucose cotransporter 2 inhibitors have been demonstrated to promote reverse cardiac remodeling in people with diabetes or heart failure. Although it has been theorized that sodium-glucose cotransporter 2 inhibitors might afford similar benefits in people without diabetes or prevalent heart failure, this has not been evaluated. We sought to determine whether sodium-glucose cotransporter 2 inhibition with empagliflozin leads to a decrease in left ventricular (LV) mass in people without type 2 diabetes or significant heart failure. Methods: Between April 2021 and January 2022, 169 individuals, 40 to 80 years of age, without diabetes but with risk factors for adverse cardiac remodeling were randomly assigned to empagliflozin (10 mg/d; n=85) or placebo (n=84) for 6 months. The primary outcome was the 6-month change in LV mass indexed (LVMi) to baseline body surface area as measured by cardiac magnetic resonance imaging. Other measures included 6-month changes in LV end-diastolic and LV end-systolic volumes indexed to baseline body surface area and LV ejection fraction. Results: Among the 169 participants (141 men [83%]; mean age, 59.3±10.5 years), baseline LVMi was 63.2±17.9 g/m 2 and 63.8±14.0 g/m 2 for the empagliflozin- and placebo-assigned groups, respectively. The difference (95% CI) in LVMi at 6 months in the empagliflozin group versus placebo group adjusted for baseline LVMi was –0.30 g/m 2 (–2.1 to 1.5 g/m 2 ; P =0.74). Median baseline (interquartile range) NT-proBNP (N-terminal-pro B-type natriuretic peptide) was 51 pg/mL (20–105 pg/mL) and 55 pg/mL (21–132 pg/mL) for the empagliflozin- and placebo-assigned groups, respectively. The 6-month treatment effect of empagliflozin versus placebo (95% CI) on blood pressure and NT-proBNP (adjusted for baseline values) were –1.3 mm Hg (–5.2 to 2.6 mm Hg; P =0.52), 0.69 mm Hg (–1.9 to 3.3 mm Hg; P =0.60), and –6.1 pg/mL (–37.0 to 24.8 pg/mL; P =0.70) for systolic blood pressure, diastolic blood pressure, and NT-proBNP, respectively. No clinically meaningful between-group differences in LV volumes (diastolic and systolic indexed to baseline body surface area) or ejection fraction were observed. No difference in adverse events was noted between the groups. Conclusions: Among people with neither diabetes nor significant heart failure but with risk factors for adverse cardiac remodeling, sodium-glucose cotransporter 2 inhibition with empagliflozin did not result in a meaningful reduction in LVMi after 6 months. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04461041.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Empagliflozin and Left Ventricular Remodeling in People Without Diabetes: Primary Results of the EMPA-HEART 2 CardioLink-7 Randomized Clinical Trial
- Date Crossref
- 24/01/2023
- Éditeur
- Ovid Technologies (Wolters Kluwer Health)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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St. Michael's Hospital A.T.Y.) pays non établi dans la noticeÉtablissement de santé
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University of Toronto Department of Medicine (K.A.C. pays non établi dans la noticeUniversité ou école supérieure
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St Michael’s Hospital pays non établi dans la noticeÉtablissement de santé
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University of British Columbia pays non établi dans la noticeUniversité ou école supérieure
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Chang Gung University pays non établi dans la noticeUniversité ou école supérieure
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Keelung Chang Gung Memorial Hospital Department of Diagnostic Radiology (C.-W.C.) pays non établi dans la noticeÉtablissement de santé
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Chang Gung Memorial Hospital Department of Medical Imaging and Intervention pays non établi dans la noticeÉtablissement de santé
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Ching Kuo Institute of Management and Health Department of Nursing pays non établi dans la noticeÉtablissement de santé
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Linkou Chang Gung Memorial Hospital pays non établi dans la noticeÉtablissement de santé
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Royal College of Surgeons in Ireland pays non établi dans la noticeUniversité ou école supérieure
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Western University pays non établi dans la noticeUniversité ou école supérieure
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Wake Forest University pays non établi dans la noticeUniversité ou école supérieure
A.T.Y.) — St. Michael's Hospital, Department of Medicine (K.A.C. — University of Toronto et St Michael’s Hospital, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.