Subject: Assessment of PRevalence, Diagnostic and TrEatment Approaches of Cholestasis & Fibrosis in Metabolic Dysfunction-Associated SteatOtic Liver Disease by HEalthcare ProfessionaLs in India (REMODEL)
Non-alcoholic fatty liver disease (NAFLD), characterized by the deposition of excessive hepatic fat, has emerged as the most common cause of chronic liver disease, a leading indication for liver transplantation, and is responsible for significant clinical and economic burden worldwide. Metabolic dysfunction-associated steatotic liver disease (MASLD) has replaced the old term NAFLD. The spectrum of MASLD includes steatosis, metabolic dysfunction-associated steatohepatitis (MASH, previously NASH), fibrosis, cirrhosis and MASH-related hepatocellular carcinoma (HCC). Most NAFLD patients have elevated alanine aminotransferase, while cholestatic enzymes are elevated less commonly. Raised cholestatic enzymes among NAFLD patients may predict a histologically more advanced disease.
The global prevalence of NAFLD in the general population is approximately 20-30% which increases to 70-90% in the obese or diabetic population. Meanwhile, it is also observed to develop in 10-15% of the lean (non-obese) population where the investigations are still progressing to explore the responsible mechanisms.
The key diagnostic challenges in NAFLD are to accurately detect and quantify complications to identify those at highest risk of liver-related morbidity and mortality. Apart from resmetirom which is approved by US FDA in March 2024 in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) in the USA and Nor Ursodeoxycholic acid approved by CDSCO for the treatment of NAFLD in India in February 2025 there are no other approved drugs for the treatment of NAFLD.
Knowledge about treating complications of end-stage liver disease due to NASH becomes an increasingly important cornerstone in the treatment of the broad disease spectrum of MASLD. This survey will help to understand the prevalence of MASLD and its complications like cholestasis and fibrosis, diagnostic practices followed by healthcare professionals and approach for its treatment in India.
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