Subject: Evaluation of prevalence and current management practices of established ASCVD in Indian patients with type 2 diabetes mellitus (LEGACY- II)

Diabetes is endemic in India, and the International Diabetes Federation (IDF 2021) has estimated that India currently has around 74 million people with type 2 diabetes mellitus (T2DM) and the numbers are poised to increase to 125 million in the next 20 years.

Cardiovascular diseases (coronary heart disease, stroke, peripheral arterial disease) are the major causes of morbidity and mortality in T2DM. It has been reported that 60–80% of patients with diabetes die of cardiovascular events.

T2DM is a well-established risk factor for cardiovascular disease (CVD). Diagnosis of T2DM doubles the cardiovascular risk in men and more than triples the risk in women. Moreover, diabetic vascular disease is responsible for 2 to 4-fold rise in the occurrence of coronary artery disease (CAD) and stroke, and 2 to 8-fold increase in the risk of heart failure.

Cardiovascular disease (CVD) is one of the most prevalent comorbidities of type 2 diabetes mellitus (T2DM) and the primary cause of death in patients with T2DM. Effective glucose lowering alone is not consistently linked with a clinically relevant impact on lowering risk of adverse cardiovascular (CV) outcomes. Identification of clinically effective and cost‐efficient strategies for the co‐management of T2DM and CVD continues to be an important goal to improve health and contain healthcare expenditures.

In recent years, large cardiovascular outcomes trials (CVOTs) have demonstrated CV benefits with glucagon‐like peptide‐1 receptor agonists (GLP‐1RA) and sodium‐glucose co‐transporter‐2 inhibitor (SGLT2i).

Based on the results of CV outcome studies, the American Diabetes Association (ADA), in their Standards of Medical Care in Diabetes, incorporated a specific recommendation to consider GLP‐1RA and SGLT2i in patients with established atherosclerotic CVD (ASCVD) to reduce the risk of mortality.

Reducing atherosclerotic cardiovascular disease (ASCVD) burden in diabetes mellitus is a major clinical imperative that should be prioritized to reduce premature death, improve quality of life, and lessen individual and economic burdens of associated morbidities, decreased work productivity, and high cost of medical care.

Atherosclerotic cardiovascular disease remains the principal cause of death and disability among patients with diabetes mellitus, especially in those with type 2 diabetes mellitus in whom it typically occurs 14.6 years earlier, with greater severity, and with more diffuse distribution than in individuals without diabetes mellitus.

Currently, there is limited evidence on prevalence of established ASCVD and status of its control in Indian patients with T2DM. Thus in lieu of the above, the present study is planned to evaluate the prevalence and current management practices of established ASCVD in T2DM patients in India.

We invite you to participate in this study. On acceptance, you will need to capture the relevant data as mentioned in the standard Data Collection Form (DCF) provided, from the patient’s medical records (case papers and investigational reports – hereafter referred as source documents).