Empagliflozin's Effects on Carotid Ultrasound Parameters in Type 2 Diabetes Patients Post-ST-Elevation Myocardial Infarction: A Randomized Controlled Trial.

Abstract

Background: Patients with type 2 diabetes (T2D) and recent ST-elevation myocardial infarction (STEMI) face accelerated atherosclerosis and a high risk of recurrent cardiovascular events. Sodium-glucose cotransporter-2 inhibitors (SGLT2i), particularly empagliflozin, offer proven cardioprotection in T2D. This study investigated the 3-month effects of empagliflozin on carotid intima-media thickness (CIMT) and Doppler hemodynamic parameters (resistive index [RI] and pulsatility index [PI]) in T2D patients post-STEMI.

Methods: In this randomized clinical trial, 80 patients with T2D and a recent STEMI from Ayatollah Mousavi Hospital, Zanjan, Iran (from July to December 2025), were randomized in a 1:1 ratio to empagliflozin 10 mg daily or an identical placebo, in addition to standard therapy. The primary endpoint was the change in CIMT at 3 months, assessed using B-mode ultrasound. Secondary endpoints included changes in RI and PI, measured via Doppler ultrasound.

Results: Follow-up data were available for 78 patients (two deaths in the intervention arm, both unrelated to the study drug). In the primary intention-to-treat analysis (n=80), empagliflozin was associated with a significant reduction in left CIMT compared with controls (median change=-0.13 mm vs. -0.01; within-group P=0.002; between-group ΔCIMT P=0.004; ANCOVA-adjusted P<0.001) versus controls (-0.01 mm). A smaller though statistically significant difference was also observed for right CIMT (ΔCIMT, P=0.021; ANCOVA-adjusted P=0.006). These findings remained consistent in the per-protocol analysis. After Bonferroni correction, the reduction in left CIMT remained significant, whereas the effect on right CIMT became more modest. No significant changes were observed in RI or PI.

Conclusion: Short-term empagliflozin suggested favorable changes in CIMT in high-risk T2D patients post-STEMI, without detectable effects on RI or PI.Iranian Registry of Clinical Trials: IRCT20230727058945N1.