Assessment of the Safety, Efficacy, and Benefit of Empagliflozin in Patients With Type 2 Diabetes Mellitus (T2DM) and Heart Failure With Reduced Ejection Fraction (HFrEF) at High Risk for Cardiovascular Events.

Background Since the increasing prevalence of type 2 diabetes mellitus (T2DM), heart failure coexisting with it has had a significant impact on clinical management and prognosis. Patients with T2DM and heart failure with reduced ejection fraction (HFrEF) have increased mortality and morbidity. Empagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, is widely acknowledged to reduce cardiovascular risk in T2DM patients. We wanted to assess the composite outcomes of heart failure, cardiovascular death, and hospitalization following the start of empagliflozin therapy in the Saudi population. Methods This is a retrospective observational study conducted at King Fahad Armed Forces Hospital-Jeddah. We included patients aged 18 or older, male or female, with T2DM with HFrEF <40% and with a risk of cardiovascular events who were treated with empagliflozin 25 mg once daily as combination therapy and patients using other diabetic agents without empagliflozin as the comparative group. Results A total of 195 patients with T2DM and HFrEF who were at high risk for cardiovascular (CV) events were included in the study. Regarding gender, most of the patients (82.1%) were male with an average age of 61.28 ± 9.92. The patients were divided into 71 individuals who received empagliflozin and 124 who did not. When comparing the surgical procedure and comorbid status of the patients, coronary artery bypass graft (1.4%), coronary artery disease (5.6%), dyslipidemia (5.6%), and ischemic cardiomyopathy (0%) were found compared to the non-empagliflozin group. Meanwhile, hypertension was found to be 71.8% and ischemic heart disease was 50.7% in empagliflozin patients. Furthermore, only dyslipidemia differed significantly (p <0.001) between the empagliflozin and non-empagliflozin groups of patients. However, no significant differences were observed between the average low-density lipoprotein (p = 0.990) and high-density lipoprotein (p = 0.399). There was no significant difference observed in the primary outcome of CV deaths or hospital admission of patients between empagliflozin and non-empagliflozin. No deaths were reported in either of the comparative groups in our study. Conclusion In this study, there was no significant difference observed in hospital admission of the patients between the empagliflozin and non-empagliflozin groups. No cardiovascular mortality was reported in the study population. Further matched group comparative studies or placebo-controlled studies are required to compare the existing evidence of the impact of empagliflozin on T2DM patients with HFrEF and at high risk for CV deaths or hospital admission.