Dear Dr. {{$doctorName}},
Subject: Evaluation of Drug Utilization Pattern of Rosuvastatin in Indian Hypertensive patients with Dyslipidemia with history of PCI or CABG for Coronary Artery Disease (ROSULEAD-II -Study) |
Dyslipidaemia and in particular the triad of atherogenic lipoproteins (raised LDL-C, raised triglycerides, and low HDL-C) are associated with an increased risk of cardiovascular events. However, only treatments that significantly improve LDL-C have been shown to improve the cardiovascular outcomes. Statins are effective in reducing LDL-C levels in patients with established cardiovascular disease or those at high risk. In addition, statins have a moderate beneficial effect on triglyceride and HDL-C levels and they may have pleiotropic effects that lead to benefits. In India, the prevalence of Ischemic Heart Disease is around 23.8 million, the prevalence of CAD is 21.4% for diabetics and 11% for non-diabetics. The prevalence of CAD in rural parts of country is nearly half than that in urban population. In secondary prevention of cardiovascular disease (CVD), studies have demonstrated that higher intensity levels of statin therapy are more effective than lower levels in reducing mortality rates. In post-MI cases, guideline compliant high intensity statins & adherence significantly lower risk of Major Adverse Cardiac Events (MACE) by 16% and statin adherence lowers MACE by 7%. Additionally, recent guideline statements have recommended high-intensity statin therapy (i.e., atorvastatin 80 mg or rosuvastatin 20-40 mg) for nearly all patients who have undergone cardiac intervention. For patients who cannot tolerate high-dose statins and those with contraindications, Ezetimibe may be also considered.
The risk of Coronary Heart Disease (CHD) in patients with dyslipidemia will increase if dyslipidemia is accompanied by one or more other CHD risk factors. Various studies showed that other factors that can cause cardiovascular disease as hypertension. Dyslipidemia and hypertension are established risk factors of prime importance in cardiovascular disease. If these two factors (dyslipidemia and hypertension) are present together, this will accelerate the process of atherosclerosis, thus increasing the risk of CHD. Evidence on optimal dosing of statin in hypertensive patients who have undergone CABG or PCI is limited in India.
In lieu of the above, the present study is planned to understand drug utilization pattern of rosuvastatin in patients who have undergone CABG or PCI for coronary artery disease.
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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