Use of emgliflozin in the prevention of cardotoxicity.The EMPACARD - PILOT TRIAL. 12 - months Follow -up

Background Anthracycline-based chemotherapy remains a cornerstone in the treatment of several common malignancies, including breast cancer, lymphoma, and sarcoma. However, its use is associated with a significant risk of cancer therapy-related cardiac dysfunction (CTRCD). Identifying effective cardioprotective strategies is therefore a critical priority in cardio-oncology. have suggested that sodium-glucose cotransporter-2 (SGLT2) inhibitors, such as empagliflozin, may offer cardioprotective benefits in this setting. Purpose Demonstrate that empagliflozin may serve as a promising strategy to mitigate anthracycline-induced CTRCD. Methods The EMPACARD PILOT Trial is a prospective case–control study enrolling breast cancer patients scheduled to receive four cycles of doxorubicin at 60 mg/m² . The HFA-ICOS score was used to identify patients at high or very high risk of CTRCD. Patients with diabetes mellitus or heart failure with preserved ejection fraction (HFpEF) at baseline received empagliflozin (10 mg/day), starting seven days before anthracycline administration and continuing for 12 months. Patients without baseline diabetes or HFpEF served as controls. The primary endpoints were a decrease in left ventricular ejection fraction (LVEF) of ≥10% to a final value < 50% or a reduction in global longitudinal strain (GLS) of at least 15% from baseline at any point during the study. Secondary endpoints included cardiovascular mortality, cardiovascular hospitalization, or heart failure. Exploratory endpoints included increases in serum troponin and NT-proBNP levels and a decrease in the glomerular filtration rate (GFR). All calculations were done with R version 4.3.3. Results A total of 76 patients were included, with 38 receiving empagliflozin and 38 placebo. The mean age was 67 years in the empagliflozin group and 66 years in the placebo group. Hypertension prevalence (95% vs 97%). Diabetes (87% vs 82%). Baseline LVEF (59.3 ± 4.7 vs 58.3 ± 4.7 p = 0,6). Elevated baseline NT-proBNP (13% vs 13%). Prevalence of prior myocardial infarction or revascularization history (11% vs. 11%). Statin use (66% vs. 79%). Betablocker use (58% vs. 34% p= 0,038). Empagliflozin treatment was associated with significant reductions in both primary endpoints: a decrease in LVEF (42% vs. 5.3%; p < 0.001) and a decrease in GLS (47% vs. 5.3%). Significant improvements were observed in NT-proBNP levels, LVEF (Figure 1), NYHA functional class, and clinical heart failure status. When adjusting for beta-blocker use, the protective effect of empagliflozin remained significant. No differences were observed in cardiovascular mortality, heart failure-related hospitalizations, troponin levels, or GFR between groups. Conclusion Empaglifozin appears to be an effective cardioprotective strategy for preventing CTRCD in cancer patients receiving anthracycline-based chemotherapy.Left Ventricle ejection overtime Outcomes according to treatment arm