Nonalcoholic fatty liver disease (NAFLD) affects one out of four people in the world, making it the most prevalent of all liver diseases and a major public health problem. The disease is defined by abnormally increased fat deposition in liver cells, which can progress with the addition of inflammation and cell damage to nonalcoholic steatohepatitis (NASH), leading to progressive stages of fibrosis and, finally, cirrhosis. Early NASH is characterized by fat and inflammation associated with minimal amounts of fibrosis, and late NASH is associated with advanced fibrosis or cirrhosis. NAFLD is most closely associated with obesity and diabetes, although there are likely other genetic, nutritional, and environmental factors involved in the pathogenesis.
Although there are no approved pharmacologic treatments for NAFLD, NASH, or cirrhosis, there are over a dozen different companies researching possible treatments. However, the development of drug therapies for the NAFLD spectrum of disease is hampered by a number of challenges:
- the chronic nature of the disorder and ultimately low morbidity and mortality,
- the impact of weight loss on the disease,
- a complex and poorly defined pathophysiology,
- the lack of easily administered diagnostic testing, and
- the evolving status of regulatory endpoints.
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The results of multiple clinical trials over the next few years will clarify potential therapies and target pathways. © Sebastian Kaulitzki/Fotolia] |