Subject:Evaluation of Drug Utilization pattern of Rosuvastatin in Indian Diabetes mellitus Patients with Dyslipidemia with or without CAD (ROSULEAD-III Study)
Diabetes mellitus (DM) is a common metabolic disorder characterized by chronic hyperglycemia and altered metabolism of carbohydrates, fats, and proteins due to defects in insulin secretion and action, or both. It is a global public health issue. In 2019, about 5 million adults died from DM and its complications. Cardiovascular disease (CVD) is a major cause of morbidity and death in DM patients, and dyslipidemia is one of the major modifiable risk factors for CVD in DM patients. Dyslipidemia is more common in DM patients because important enzymes and lipid metabolism pathways are affected. Type 2 diabetes (T2DM) increases the risk of CVD several fold. Over 50% of T2DM patients die of complications from coronary heart disease (CHD). Dyslipidemia is a collection of metabolically interrelated plasma lipid and lipoprotein abnormality involving low high-density lipoprotein cholesterol (HDL-C), high low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC) and triglyceride (TG) levels. In DM patients, the most common patterns of dyslipidemia were hypertriglyceridemia, decreased HDL cholesterol levels, and elevated levels of LDL particles and it heightens the risk of CVD among DM patients. Dyslipidemia is increasing in many developing countries due to obesity, westernization of local diets, aging populations, reduced physical activity, and other adverse lifestyle changes. The first step in determining treatment goals for diabetic patients is a comprehensive assessment of their cardiovascular risk. The American Diabetes Association (ADA) and European Society of Cardiology (ESC)/European Association for the Study of Diabetes (EASD) recommend reducing LDL < 100 mg/dl (2.6 mmol/l) for diabetic patients without additional cardiovascular risk. High-risk diabetic patients with additional cardiovascular risk factors should achieve a target of LDL < 70 mg/dl (1.8 mmol/l). If this cannot be achieved, lowering LDL 30%–40% (ADA) or ≥ 50% (ESC/EASD) from baseline value is an alternative goal. While lifestyle modification and glucose control may help to prevent microvascular complications of diabetes, they have little effect on cardiovascular events. Statin-based lipid lowering therapy, on the other hand, has been shown to reduce cardiovascular morbidity and mortality in a wide range of diabetic patients.16 Diabetic dyslipidemia should therefore be treated with statins.
This retrospective, cross-sectional multicenter study is planned to evaluate the drug utilization pattern Rosuvastatin in Indian Diabetes mellitus Patients with Dyslipidemia with or without CAD 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).
We would recommend you to capture data fulfilling the criteria as outlined in the protocol and whose relevant laboratory investigations are available for the preceding 3 months.
We wish to inform you that the DCF will capture all data in de-identified form and any identifiable parameters which may potentially disclose the identity of the patient such as name or address will strictly not be captured so as to ensure we maintain patient confidentiality. We would encourage you to carefully fill all available information to the fullest as recommended in the DCF.
In alignment with good clinical research practices, an independent CRO will monitor this study and do the source data verification of the data captured in the DCF with copies of the patients’ source medical records (case papers and investigational reports) to ensure that the data entered in the DCFs are accurate and in alignment with the patients’ medical records.
If you agree to participate in the said study, we would request you to sign and return the enclosed reply along with your visiting card for accuracy of records.
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