Date: {{$ActivityAssignDate}}

Dear Dr. {{$doctorName}},

Subject: Assessment of drug utilization patterns of Rosuvastatin in young Indian patients (18-45 years) with ASCVD risk factors like type 2 diabetes mellitus and dyslipidemia (MORE-CV study)

Diabetes is considered as a coronary heart disease (CHD) risk equivalent and is frequently associated with various other cardiovascular (ASCVD) risk factors. It is well-established that dyslipidemia is a major risk factor for macrovascular complications in patients with type-2 diabetes mellitus (T2DM) and multiple studies across the globe have shown that it affects 10%-73% of this population. The prevalence of high cholesterol in Indian population is 25–30% in urban and 15–20% in rural population.

An epidemiological survey involving 4,600 newly diagnosed patients with diabetes across India found that nearly half (46.7%) of the subjects were under the age of 40 years and 40% were between the ages of 41–50 years Despite nearly 90% of individuals being younger than 50 years old, hypertension, obesity, dyslipidemia and ischemic heart disease were observed in 23.3%, 26%, and 27% and 6% of patients respectively. According to the ICMR-INDIAB study, the typical age of onset of type 2 diabetes among Asian Indians occurs between 25 and 34 years of age, which is a decade or two earlier than for Western populations..

The prevalence of high cholesterol in Indian population is 25–30% in urban and 15–20% in rural population. In a study conducted by Parekh RM et al, the incidence of dyslipidemia in patients with diabetes mellitus was found to be 85.5% in males and 97.8% in females.

In T2DM apart from LDL cholesterol, a low HDL-C or only elevated TGs, or atherogenic dyslipidemia (Low HDL-C and ApoA, elevated both fasting and post-prandial TGs, elevated small dense LDL particles, and elevated ApoB) is a self-determining predictor of cardiovascular risk. Moreover, these patients when optimally treated with lipid lowering therapy has shown to significantly reduce CVD events and cardiovascular risks.

According to the National Health Portal of India, approximately 25–30% of urban and 15–20% of rural individuals in India have dyslipidemia. Although it affects both sexes, men are more likely to experience it. Data presented at 70th Annual Conference of the Cardiological Society of India (CSI), 2018 revealed that Indians possess more risk of developing hypertension in early years of life than western cohorts and incidence of first heart attack and strokes a decade earlier on average cannot be ignored.

The excess mortality risk in T2DM is due to high prevalence of major cardiovascular risk factors such as hypertension (HTN), lipid abnormalities, smoking and obesity that are in addition to factors specific to T2DM like hyperglycemia, diabetic dyslipidemia, and oxidation-related and glycation-related vascular injury.

ADA 2023 recommends for people with diabetes, it is recommended to use high intensity statin therapy to reduce LDL cholesterol by <50% of baseline and to target an LDL cholesterol goal of <70 mg/dL, and those with no ASCVD use moderate-intensity statin therapy in addition to lifestyle therapy.

Although diabetes and dyslipidemia commonly coexist in India, there is a lack of evidence on whether dyslipidemia is adequately managed or not, in alignment with LAI 2020 and ADA 2023 guidelines. At present, there is lack of country wide data to obtain meaningful insights on the drug utilization pattern of statins in young patients (18-45 years of age) with diabetes mellitus having concomitant ASCVD risk factors.