Empagliflozin significantly reduces the capacity of sera to induce endothelial dysfunction in Ischemia Non-Obstructive Coronary Arteries (INOCA): EMbArk phase II pilot trial
Abstract
Ischemia with Non-Obstructive Coronary Arteries (INOCA) is seen in up to 70% of patients with angina undergoing invasive coronary angiography. In INOCA patients, with coronary microvascular dysfunction (CMD) and underlying endothelial dysfunction (EnD)-induced inflammation and excessive reactive oxygen species (ROS) signaling leads to increased release of cytokines, upregulation of leucocyte adhesion molecules, the release of endothelial microvesicles (eEVs), and ultimately EC apoptosis. In vitro studies have found Sodium Glucose Co-Transporter 2 inhibitors (SGLT2i) reverse EnD. However, the effect of SGLT2i on EnD in an INOCA population with CMD has not been studied.
Phase II open label pilot trial in INOCA patients with CMD treated with the SGLT2i Empagliflozin (EMPA, 10mg/daily) for 90 days. Blood samples were collected at baseline and after 45 days of treatment (n = 7), baseline samples were compared to no-CMD controls stored samples (n = 4). Cultured Human Coronary Artery Endothelial Cells (HCAECS) were exposed to sera from the 3 groups at various concentrations (5,10,20%); and cell viability, apoptosis, eEV release, VCAM-1 concentrations, and mitochondrial ROS staining were quantified.
In an all-female cohort, the mean age was 60 years (SD 12) (Table 1). Compared to no-CMD controls HCAECs, incubated with sera from INOCA patients with CMD had significantly higher apoptosis (Fig. 1A) and lower viability (Fig. 1B) that significantly improved following EMPA treatment (Fig.…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 7 participants or records.
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