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

Abstract

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.