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NASH Treatment Options Are Limited1
Patients with NAFLD or NASH should be encouraged to exercise regularly and maintain a healthy diet2
  • Significant improvement in steatosis, lobular inflammation, and ballooning may be possible with ≥9% weight loss2; however, this may prove difficult for many patients
    In a study of 924 NAFLD patients who received weight loss counseling, fewer than 20% lost at least 5% of their body weight over approximately 1 year3
  • Patients with advanced disease may require a liver transplant4
There is an urgent need to develop preventive and therapeutic strategies against NASH1,7
short-term treatment goals7,8
  • Reduce liver fibrosis
  • Prevent progression to cirrhosis
long-term treatment goals7-9
  • Improve clinical outcomes by reducing
    Cardiovascular complications
    Hepatic complications
  • Evidence shows that cirrhosis is predictive of clinical outcomes7,8
    The FDA recommends improvement in fibrosis with no worsening of NASH, or the prevention of progression of fibrosis with resolution of NASH, as suitable endpoints for clinical trials1
    There is insufficient evidence to suggest that improvement of NAFLD activity score (NAS) alone is predictive of improved clinical outcomes7,9
  • Ongoing research is investigating potential treatment targets for patients with NASH4,8
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  1. Sanyal AJ, Brunt EM, Kleiner DE, et al. Endpoints and clinical trial design for nonalcoholic steatohepatitis. Hepatology. 2011;54(1):344-353.
  2. Chalasani N, Younossi Z, Lavine JE, et al. The diagnosis and management of non-alcoholic fatty liver disease: practice guideline by the American Gastroenterological Association, American Association for the Study of Liver Diseases, and American College of Gastroenterology. Gastroenterology. 2012;142(7):1592-1609.
  3. Dudekula A, Rachakonda V, Shaik B, Behari J. Weight loss in nonalcoholic fatty liver disease patients in an ambulatory care setting is largely unsuccessful but correlates with frequency of clinic visits. PLoS One. 2014:9(11):e111808.
  4. Chalasani N, Younossi Z, Lavine JE, et al. The diagnosis and management of nonalcoholic fatty liver disease: practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018;67(1):328-357.
  5. Charlton MR, Burns JM, Pedersen RA, Watt KD, Heimbach JK, Dierkhising RA. Frequency and outcomes of liver transplantation for nonalcoholic steatohepatitis in the United States. Gastroenterology. 2011;141(4):1249-1253.
  6. Noureddin M, Vipani A, Bresee C, et al. NASH leading cause of liver transplant in women: updated analysis of indications for liver transplant and ethnic and gender variances. Am J Gastroenterol. 2018. Jun 8. doi:10.1038/s41395-018-0088-6.
  7. Sanyal AJ, Friedman SL, McCullough AJ, Dimick-Santos L; American Association for the Study of Liver Diseases; United States Food and Drug Administration. 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. Hepatology. 2015;61(4):1392-1405.
  8. Filozof C, Goldstein BJ, Williams RN, Sanyal A. Non-alcoholic steatohepatitis: limited available treatment options but promising drugs in development and recent progress towards a regulatory approval pathway. Drugs. 2015;75(12):1373-1392.
  9. Filozof C, Chow SC, Dimick-Santos L, et al. Clinical endpoints and adaptive clinical trials in precirrhotic nonalcoholic steatohepatitis: facilitating development approaches for an emerging epidemic. Hepatol Commun. 2017;1(7):577-585.