Efficacy of oral semaglutide on cardiovascular risk in patients with type 2 diabetes mellitus: A real-life study

Background: The efficacy of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in glycemic control and cardiovascular risk reduction in type 2 diabetes mellitus (T2DM) is well established. Real-world, non-interventional studies are increasingly essential to gather information from routine clinical practice. Objective of the Study: This multicenter, observational, retrospective, single-arm study aims to assess the effect of oral semaglutide on surrogate markers of cardio-metabolic risk (such as Visceral Adiposity Index, triglyceride-glucose index, Lipid Accumulation Product), as well as on glycemic control, renal function markers (creatinine, eGFR, microalbuminuria), and lipid profile, in adult patients with T2DM who are naive to GLP-1 RA therapy. Materials and Methods: A total of 154 adult diabetic patients (106 male, 48 female; mean age 64.4±10.5 years) with an average disease duration of 10 years (10.1±8.4) were evaluated. Patients initiated oral semaglutide treatment according to AIFA note 100 guidelines and were followed at diabetes outpatient clinics in ASST Bergamo Ovest, Garda, and Mantova. Clinical, biochemical, and anthropometric data for each patient were collected at the beginning of treatment (T0) and after 12 months (T12). Results: The main results are presented in the table below: Variables T0 T12 P-value BMI, Kg/m2 (mean±SD) 31.2±5.2 29.6±5.1 <0.001 Waist circumference, cm (mean±SD) 105.9±10.3 99.9±9.9 <0.001 Fasting glucose, mg/dL (mean±SD) 154.7±43.1 124.8±30.5 <0.001 HbA1c, % (mean±SD) 7.8±1.2 6.7±0.9 <0.001 Total cholesterol, mg/dL (mean±SD) 171.9±40.0 154±34.7 <0.001 HDL cholesterol, mg/dL (mean±SD) 47.7±11.9 52.0±12.2 <0.001 LDL cholesterol, mg/dL (mean±SD) 93.8±36.1 81.5±80.8 0.05 Triglycerides, mg/dL (mean±SD) 157.2±74.2 132.9±57.0 <0.001 eGFR, ml/min/1.73m² (mean±SD) 62.8±17.2 67.7±20.6 <0.001 Urinary albumin/creatinine ratio, mg/g [median (IQR)] 38.5 (14.3-81.8) 12 (5.6-34.3) <0.001 Systolic blood pressure, mmHg (mean±SD) 134.8±14.6 131.4±15.2 0.015 Diastolic blood pressure, mmHg (mean±SD) 78.3±8.7 75.8±8.5 0.003 Visceral Adiposity Index [median (IQR)] 2.4 (1.6-3.4) 1.7 (1.0-2.6) <0.001 Triglyceride-glucose index [median (IQR)] 5.9 (4.8-5.2) 4.8 (4.7-4.9) <0.001 Lipid Accumulation Product [median (IQR)] 77.0 (52.8-111.6) 56.1 (35.2-80.9) <0.001 Conclusions: Exposure to oral semaglutide for 12 months in T2DM patients resulted in significant improvements in glycemic control, renal function parameters, and surrogate markers of cardiovascular risk.