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Cardiovasc Diabetol. 2024;23(1):373.

Effect of ertugliflozin on left ventricular function in type 2 diabetes and pre-heart failure: the Ertu-GLS randomized clinical trial.

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제1저자 임수, 배재현 · 교신저자 임수

PMID 39438942 PMC11515769 DOI 10.1186/s12933-024-02463-0 IF 15.6 내분비대사내과
소속 (4)
  1. Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea. limsoo@snu.ac.kr.
  2. Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
  3. Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
  4. Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.

Abstract

BACKGROUND The therapeutic effects of ertugliflozin, a sodium-glucose cotransporter 2 inhibitor, on cardiovascular outcome are not fully understood. This study aimed to evaluate the efficacy and safety of ertugliflozin on cardiac function in people with type 2 diabetes and pre-heart failure.

METHODS We conducted a 24-week randomized, double-blind, placebo-controlled trial involving individuals with type 2 diabetes inadequately controlled with antidiabetic medications. Participants with left ventricular hypertrophy, E/e' >15, or impaired left ventricular global longitudinal strain (LVGLS) were randomized 1:1 to receive either ertugliflozin (5 mg once daily) or a placebo. The primary outcome was the change in LVGLS. Secondary outcomes included changes in left ventricular mass index (LVMI) and left ventricular ejection fraction (LVEF). Prespecified exploratory outcomes, including angiotensin-converting enzyme 2 (ACE2) and angiotensin (1-7) levels, were also assessed.

RESULTS A total of 102 individuals (mean age, 63.9 ± 9.2 years; 38% women) were included. The ertugliflozin group showed a significant improvement in LVGLS (- 15.5 ± 3.1% to - 16.6 ± 2.8%, P = 0.004) compared to the placebo group (- 16.7 ± 2.7% to - 16.4 ± 2.6%, P = 0.509), with a significant between-group difference (P = 0.013). Improvements in LVMI and LVEF were also observed. Additionally, significant reductions in HbA1c, systolic blood pressure, whole-body and visceral fat, uric acid, proteinuria, N-terminal pro-B-type natriuretic peptide, and lipoprotein(a) were noted. ACE2 and angiotensin (1-7) levels significantly increased in the ertugliflozin group compared to the placebo group and correlated with changes in LVGLS [r = 0.456, P < 0.001 for ACE2; r = 0.541, P < 0.001 for angiotensin (1-7)]. Adverse events were similar between the two groups.

CONCLUSIONS This study demonstrated that ertugliflozin has beneficial effects on left ventricular function in individuals with type 2 diabetes and pre-heart failure, and it provided insights into potential underlying mechanisms.

CLINICAL TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03717194.

© 2024. The Author(s).

Keywords

Angiotensin (1–7)Angiotensin-converting enzyme 2Diabetes mellitus, type 2ErtugliflozinGlobal longitudinal strainHeart function testsSodium-glucose transporter 2 inhibitors

Figures

Fig. 1
Fig. 1 CONSORT diagram showing the trial profile
Fig. 2
Fig. 2 Comparison of changes in echocardiographic parameters between ertugliflozin treatment (n = 48) and placebo (n = 46) for 24 weeks. LAVI, left atrium volume index; LV, left ventricle; LVEDV, left ventricular end-diastolic volume; LVGLS, left ventricular global longitudinal strain. The dashed line represents the median, and the dotted lines indicate the quartiles
Fig. 3
Fig. 3 Comparison of changes in serum NT-proBNP (A), troponin-T (B), ACE2 (C), and angiotensin (1–7) (D) levels after 24 weeks of ertugliflozin treatment (n = 48) or placebo (n = 46). ACE2, angiotensin-converting enzyme 2; NT-proBNP, N-terminal pro–B-type natriuretic peptide. The dashed line represents the median, and the dotted lines indicate the quartiles

그림 출처: PubMed Central 공개 논문 (PMC11515769)

Conflict of interest statement

The authors declare no competing interests.

그 밖의 정보
출판 형태
Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
저널
Cardiovascular diabetology · eISSN 1475-2840
전자 출판
2024-10-22
MeSH
Humans · Male · Diabetes Mellitus, Type 2* / drug therapy / diagnosis / blood / physiopathology / complications · Female · Sodium-Glucose Transporter 2 Inhibitors* / therapeutic use / adverse effects · Middle Aged · Aged · Double-Blind Method · Ventricular Function, Left* / drug effects · Treatment Outcome · Bridged Bicyclo Compounds, Heterocyclic* / therapeutic use / adverse effects · Stroke Volume* / drug effects · Time Factors · Ventricular Dysfunction, Left / physiopathology / drug therapy / diagnosis · Biomarkers / blood · Recovery of Function · Angiotensin-Converting Enzyme 2 / metabolism · Hypertrophy, Left Ventricular / physiopathology / drug therapy / diagnostic imaging · Heart Failure / drug therapy / physiopathology / diagnosis · Blood Glucose / drug effects / metabolism
Substances
ertugliflozin · Sodium-Glucose Transporter 2 Inhibitors · Bridged Bicyclo Compounds, Heterocyclic · Biomarkers · ACE2 protein, human · Angiotensin-Converting Enzyme 2 · Blood Glucose
데이터
ClinicalTrials.gov: NCT03717194
참고문헌
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