The DOI matches its Crossref record; 9 of the 9 references it cites were found in a registry or an index.
Challenges and opportunities in drug and biomarker development for nonalcoholic steatohepatitis: Findings and recommendations from an American Association for the Study of Liver Diseases–U.S. Food and Drug Administration Joint Workshop
Open accessAbstract
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease (CLD) in North America. It is a growing contributor to the burden of CDL requiring liver transplantation. Cirrhosis is also associated with an increased risk of hepatocellular cancer, which may occur even in the absence of cirrhosis in subjects with nonalcoholic steatohepatitis (NASH), the histological form of NAFLD associated with increased liver‐related mortality. The diagnosis of NASH currently requires a liver biopsy. There are also no U.S. Food and Drug Administration (FDA)‐approved therapies for NASH. Therefore, there is a need to develop better diagnostic and therapeutic strategies for patients with NASH, targeting both those with early‐stage disease as well as those with advanced liver fibrosis. There are unique challenges in the design of studies for these target populations. The long relatively asymptomatic time interval in the progression of NAFLD and NASH to cirrhosis and ultimately liver failure, along with gaps in knowledge regarding disease modifiers, combine to present significant challenges in trial design. Therefore, there is an urgent need to develop methods to identify the populations at particular risk of disease progression and validate endpoints that reflect meaningful changes in health status in this population. This article summarizes the discussion at a joint workshop held September 5 and 6, 2013 in Silver Spring, Maryland, sponsored by the FDA and the American Association for the Study of Liver Diseases to develop guidance on diagnostic and therapeutic modalities for NASH. (H epatology 2015;61:1392–1405)
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Cites
Nonalcoholic fatty liver disease: a spectrum of clinical and pathological severity.
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Self-citationPioglitazone, Vitamin E, or Placebo for Nonalcoholic Steatohepatitis
Sanyal, A. J., Chalasani, N., Kowdley, K. V., McCullough, A., Diehl, A. M., Bass, N. M., Neuschwander-Tetri, B. A., Lavine, J. E., Tonascia, J., Unalp, A., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa0907929 · Cited by 3,327
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Sampling Variability of Liver Biopsy in Nonalcoholic Fatty Liver Disease
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“Moreover, in view of the sampling variability associated with liver biopsies (67), there is confusion about whether it is feasible to identify and quantify disease progression within a 3-4 year time frame.”
BackgroundEpidemiology of Non-Alcoholic Fatty Liver Disease
Bellentani, S., Scaglioni, F., Marino, M., & Bedogni, G. (2010) · Digestive Diseases · doi:10.1159/000282080 · Cited by 1,026
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Pathology of nonalcoholic fatty liver disease
Brunt, E. M. (2010) · Nature Reviews Gastroenterology & Hepatology · doi:10.1038/nrgastro.2010.21 · Cited by 484
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Cited by
EASL–EASD–EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease
(2016) · Journal of Hepatology · doi:10.1016/j.jhep.2015.11.004 · Cited by 4,836
Mechanisms of NAFLD development and therapeutic strategies
Friedman, S. L., Neuschwander-Tetri, B. A., Rinella, M., & Sanyal, A. J. (2018) · Nature Medicine · doi:10.1038/s41591-018-0104-9 · Cited by 4,354
Self-citationCause, Pathogenesis, and Treatment of Nonalcoholic Steatohepatitis
Diehl, A. M., & Day, C. (2017) · New England Journal of Medicine · doi:10.1056/nejmra1503519 · Cited by 1,283
Ratziu, V., Harrison, S. A., Francque, S., Bedossa, P., Lehert, P., Serfaty, L., Romero-Gomez, M., Boursier, J., Abdelmalek, M., Caldwell, S., et al. (2016) · Gastroenterology · doi:10.1053/j.gastro.2016.01.038 · Cited by 1,035
Self-citationPast, present and future perspectives in nonalcoholic fatty liver disease
Sanyal, A. J. (2019) · Nature Reviews Gastroenterology & Hepatology · doi:10.1038/s41575-019-0144-8 · Cited by 522
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Metadata
- Authors
- Sanyal, A. J., Friedman, S. L., McCullough, A. J., & Dimick‐Santos, L.
- Venue
- Hepatology
- Published
- 2015-03-19
- Volume
- 61
- Issue
- 4
- Pages
- 1392-1405
- ISSN
- 0270-9139 (ISSN-L)
- 1527-3350
- OpenAlex
- W1996415443
- Cited by
- 354
- References
- 9
- FWCI
- 22.70
- Type
- journal article
- Language
- en
- Open access
- green
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