Subject: : Evaluation of liver enzymes and metabolic profile in Indian patients with cholestatic liver disease on pharmacotherapy – A multicenter, retrospective, cross-sectional study
Cholestasis is an acute or chronic hepatobiliary condition in which the formation, secretion, or flow of bile is impaired. Community-based data suggest that cholestasis may affect as much as 10–20% of the general population. Chronic cholestatic liver disease increases the risk for several complications, leads to rising morbidity and mortality rates associated with the underlying condition and poses a significant healthcare burden. In prolonged, severe cholestasis and in a subpopulation of predisposed individuals, it can progress to fibrosis, cirrhosis, hepatocellular-carcinoma, or cholangio-carcinoma and death can occur.
Ursodeoxycholic acid (UDCA) is the primary bile acid used in the treatment of cholestatic liver diseases. It is a hydrophilic bile acid and works by membrane stabilization, cytoprotection, and immunomodulation of affected liver cells. It reduces the risk of developing complications. Real-world evidence can help in obtaining insights into patient profile including various laboratory parameters, comorbidities, drug utilization pattern, in cholestatic liver disease patients. However, real-world data on liver biochemistries among adult patients with cholestatic liver disease from India are scarce.
In lieu of the same, the current retrospective cross-sectional study is planned to understand the hepatic enzyme pattern in Indian patients with cholestatic liver disease with or without co-morbidities receiving pharmacotherapy.
In this Retrospective cross-sectional observational study, we intend to determine the pattern of liver enzymes in Indian cholestatic liver disease patients with or without co-morbidities receiving pharmacotherapy.
We invite you to participate in this study. On acceptance, you will need to capture the relevant data as mentioned in the standard Case Record Form (CRF) 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 CRF 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 CRF.
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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