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Dear Dr. {{$doctorName}},
Subject: Participation in study “Assessment of ASCVD risk factors in Indian patients
with Type 2 Diabetes Mellitus Eligible for statin therapy and assessment of
utilization of high intensity statin therapy – A retrospective, multicenter, cross-
sectional study”
CVD is the leading cause of mortality globally (18 million lives, including 9 million from
coronary artery disease (CAD) annually). India had one of the highest mortality, most of
them premature, from CVD (2.64 million, women 1.18, men 1.45) and CAD (1.54
million, women 0.62, men 0.92) in the world. Also, 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. The primary cause of
atherosclerotic cardiovascular disease (ASCVD) is increased LDL-C. Numerous studies
over the years have conclusively shown that abnormal lipids account for more than one-
half of CAD and nearly one-half of cerebrovascular accidents (CVA) and that lipid-
lowering therapy (LLT) with statins can reduce this risk by >50%. Statin is the first-line
of drug therapy for people with high ASCVD risk regardless of their LDL-C level.
EAS/ESC 2019 guidelines have emphasized the role of suitable lipid lowering therapy as
an integral part of dyslipidemia management in high risk individuals. The benefit of
greater LDL-C reduction and serum LDL-C levels lies in lowering of ASCVD events. In
very high risk individuals, the aim is two-fold; using maximally tolerated statin therapy
and lowering LDL-C to less than 70 mg/dl.
While guidelines emphasize treating to LDL-C goals with use of moderate to high-
intensity statins/ maximally tolerated statins in individuals with high and very high
ASCVD risk, local treatment practices may differ on account of several reasons. However
there may be a variability in guideline adoption in real world setting and understanding
the real world practice may be helpful in understanding the current practice gaps in
optimal management of patients with ASCVD or high ASCVD risk.
Currently the data on real world on adoption of guidelines into clinical practice to ensure
optimal management of LDL-C levels to goals in type II Diabetes Mellitus patients is
scarce. Thus in lieu of the above, the present study is planned to assess the drug
utilization pattern of statins usage in T2DM patients in India in presence of ASCVD risk
factors and/or established ASCVD.
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.
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