Evaluation and comparison of cardioprotective efficacy and safety of dapagliflozin vs vildagliptin as an add-on therapy to standard treatment in patients with type 2 diabetes mellitus with hypertension

Introduction:

Type 2 diabetes mellitus (T2DM) and hypertension (HTN) are major contributors to atherosclerosis and cardiovascular disease (CVD). Their frequent coexistence arises from shared mechanisms like insulin resistance, endothelial dysfunction, oxidative stress, and inflammation. Current management involves lifestyle changes and pharmacological therapy. However, achieving optimal cardiometabolic control remains a challenge. Novel agents like SGLT2 inhibitors and DPP-4 inhibitors are being explored for their cardioprotective and metabolic effects beyond glucose control.

Review of Literature:

1. IL-6 levels predict future myocardial infarction, highlighting inflammation’s role in CVD.

2.The ADVANCE trial showed intensive glycemic control mainly reduces microvascular, not

macrovascular, events.

3.SGLT2 inhibitors improve body composition but may reduce muscle mass.

4.Dapagliflozin outperformed vildagliptin in improving weight and hemodynamics in T2DM

patients with CAD.

Aim:

To evaluate and compare the efficacy and safety of dapagliflozin and vildagliptin on cardiovascular risk, glycemic control, and body composition in T2DM patients with controlled HTN.

Objectives:

Primary: Assess cardioprotective efficacy (ASCVD risk score, HbA1c, lipid profile, BIA) and safety of both drugs.

Secondary: Compare quality of life using the SF-36 survey.

Rationale:

There is a lack of Indian randomized trials comparing dapagliflozin and vildagliptin in T2DM patients with HTN for visceral fat, inflammatory markers, validated CVD risk scores, and quality of life. This

study addresses that gap.

Ethical Considerations:

The study adheres to ICH-GCP and the Declaration of Helsinki. Written informed consent will be obtained. Patient data confidentiality and the right to withdraw will be maintained. Any serious adverse event will lead to patient withdrawal and appropriate treatment.

Methodology:

A prospective, open-label, randomized comparative clinical study involving 90 patients (45 per group) will be conducted. Participants will be randomly assigned to receive either dapagliflozin or vildagliptin along with standard treatment. Assessments include ASCVD risk score, HbA1c, FPG/PPG, BP, BIA parameters (VFA, muscle mass, etc.), inflammatory markers (IL-6, NLR, PLR, RPR), lipid profile, and SF-36. Evaluations will occur at baseline, 1st, 3rd, and 6th month.