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ELUCIDATE Trial: A Single-Center Randomized Controlled Study
Jiun-Lu Lin1,2, Sung-Chen Liu1,2, Tze-Fan Liu2
1Division of Endocrinology and Metabolism, Department of Internal Medicine MacKay Memorial Hospital Taipei Taiwan.
Background:
Dapagliflozin, a sodium-glucose cotransporter 2 inhibitor, is an epochal oral antidiabetic drug that improves cardiorenal outcomes. However, the effect of early dapagliflozin intervention on left ventricular (LV) remodeling in patients with type 2 diabetes free from cardiovascular disease remains unclear.
Methods And Results:
The ELUCIDATE trial was a prospective, open-label, randomized, active-controlled study that enrolled 76 patients with asymptomatic type 2 diabetes with LV ejection fraction ≥50%, randomized to the dapagliflozin 10 mg/day add-on or standard-of-care group. Speckle-tracking echocardiography-based measurements of the cardiac global longitudinal strain were performed at baseline and 24 weeks after treatment initiation. Patients who received dapagliflozin had a greater reduction in LV dimension (1.68 mm [95% CI, 0.53-2.84]; P=0.005), LV end-systolic volume (5.51 mL [95% CI, 0.86-10.17]; P=0.021), and LV mass index (4.25 g/m2.7 [95% CI, 2.42-6.09]; P<0.0001) compared with standard of care in absolute mean differences. Dapagliflozin add-on therapy led to a significant LV global longitudinal strain increment (0.74% [95% CI, 1.00-0.49]; P<0.0001) and improved LV systolic and early diastolic strain rates (0.27/s [95% CI, 0.17-0.60]; and 0.11/s [95% CI, 0.06-0.16], respectively; both P<0.0001) but not in global circumferential strain. No significant changes were found in insulin resistance, NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels, or other biomarkers at 6 months after the dapagliflozin administration.
Conclusions:
Dapagliflozin add-on therapy could lead to more favorable cardiac remodeling accompanied by enhanced cardiac mechanical function among patients with asymptomatic type 2 diabetes. Our findings provide evidence of the efficacy of dapagliflozin use for the primary prevention of diabetic cardiomyopathy.
Registration:
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03871621.
Insights
Early dapagliflozin treatment in type 2 diabetes patients improved cardiac remodeling and function. This sodium-glucose cotransporter 2 inhibitor shows promise for preventing diabetic cardiomyopathy.
Area of Science:
- Cardiology
- Endocrinology
- Pharmacology
Background:
- Type 2 diabetes (T2D) is associated with increased risk of cardiovascular complications.
- Sodium-glucose cotransporter 2 (SGLT2) inhibitors, like dapagliflozin, are established treatments for T2D and have shown cardiorenal benefits.
- The impact of early dapagliflozin intervention on left ventricular (LV) remodeling in T2D patients without pre-existing cardiovascular disease (CVD) is not well understood.
Purpose of the Study:
- To investigate the effect of early dapagliflozin add-on therapy on LV remodeling and cardiac function in patients with asymptomatic type 2 diabetes.
- To evaluate changes in LV dimensions, mass, and strain parameters following dapagliflozin treatment.
- To assess the potential of dapagliflozin in the primary prevention of diabetic cardiomyopathy.
Main Methods:
- The ELUCIDATE trial was a prospective, open-label, randomized study involving 76 patients with asymptomatic T2D and preserved LV ejection fraction (≥50%).
- Patients were randomized to receive dapagliflozin 10 mg/day add-on therapy or standard of care.
- Speckle-tracking echocardiography was used to measure cardiac global longitudinal strain at baseline and 24 weeks.
Main Results:
- Dapagliflozin treatment resulted in significant reductions in LV dimension, LV end-systolic volume, and LV mass index compared to standard care.
- Patients on dapagliflozin showed a significant increase in LV global longitudinal strain and improved systolic and early diastolic strain rates.
- No significant changes were observed in insulin resistance, NT-proBNP levels, or other biomarkers at 6 months.
Conclusions:
- Early dapagliflozin add-on therapy promotes favorable cardiac remodeling and enhances cardiac mechanical function in asymptomatic type 2 diabetes patients.
- These findings support the use of dapagliflozin for the primary prevention of diabetic cardiomyopathy.
- Dapagliflozin may offer a protective effect on the heart in T2D patients even before the onset of overt cardiovascular disease.
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