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• W2532866276 abstract "We thank Athyros et al. for their letter reviewing the use of statins in non-alcoholic steatohepatitis (NASH). We agree with them in that statin therapy in NASH is safe [ [1] Cohen D.E. Anania F.A. Chalasani N. National Lipid Association Statin Safety Task Force Liver Expert P An assessment of statin safety by hepatologists. Am J Cardiol. 2006; 97: 77C-81C Abstract Full Text Full Text PDF PubMed Scopus (316) Google Scholar ] and recommended in this population [ 2 Diabetologia. 2016; 59: 1121-1140 Crossref PubMed Scopus (320) Google Scholar , 3 Chalasani N. Younossi Z. Lavine J.E. Diehl A.M. Brunt E.M. Cusi K. et al. The diagnosis and management of non-alcoholic fatty liver disease: practice guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. 2012; 55: 2005-2023 Crossref PubMed Scopus (2548) Google Scholar ]. However, the statement that statins improve steatohepatitis is not supported by current evidence as suggested by Athyros et al. Most studies with statins in this population have been usually relatively small (≤30 patients), uncontrolled, with primary end points based on surrogate markers (not the gold-standard liver biopsy) and/or post-hoc analysis. The clinical trials quoted Athyros et al. [ 4 Tikkanen M.J. Fayyad R. Faergeman O. Olsson A.G. Wun C.C. Laskey R. et al. Effect of intensive lipid lowering with atorvastatin on cardiovascular outcomes in coronary heart disease patients with mild-to-moderate baseline elevations in alanine aminotransferase levels. Int J Cardiol. 2013; 168: 3846-3852 Abstract Full Text Full Text PDF PubMed Scopus (138) Google Scholar , 5 Athyros V.G. Giouleme O. Ganotakis E.S. Elisaf M. Tziomalos K. Vassiliadis T. et al. Safety and impact on cardiovascular events of long-term multifactorial treatment in patients with metabolic syndrome and abnormal liver function tests: a post hoc analysis of the randomised ATTEMPT study. Arch Med Sci. 2011; 7: 796-805 Crossref PubMed Scopus (93) Google Scholar , 6 Athyros V.G. Tziomalos K. Gossios T.D. Griva T. Anagnostis P. Kargiotis K. et al. Safety and efficacy of long-term statin treatment for cardiovascular events in patients with coronary heart disease and abnormal liver tests in the Greek Atorvastatin and Coronary Heart Disease Evaluation (GREACE) study: a post-hoc analysis. Lancet. 2010; 376: 1916-1922 Abstract Full Text Full Text PDF PubMed Scopus (559) Google Scholar ] were all post-hoc analysis from open-label clinical trials that used plasma aminotransferases as the primary end point to establish liver improvement. Plasma ALT is a poor indicator of the severity of NASH and typically decreases in placebo arms of RCTs in NASH, where only a minority of patients have resolution of NASH [ 2 Diabetologia. 2016; 59: 1121-1140 Crossref PubMed Scopus (320) Google Scholar , 3 Chalasani N. Younossi Z. Lavine J.E. Diehl A.M. Brunt E.M. Cusi K. et al. The diagnosis and management of non-alcoholic fatty liver disease: practice guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. 2012; 55: 2005-2023 Crossref PubMed Scopus (2548) Google Scholar ]. Our group has also shown that patients with normal compared to elevated ALT often have a similar severity of NASH [ [7] Maximos M. Bril F. Portillo Sanchez P. Lomonaco R. Orsak B. Biernacki D. et al. The role of liver fat and insulin resistance as determinants of plasma aminotransferase elevation in nonalcoholic fatty liver disease. Hepatology. 2015; 61: 153-160 Crossref PubMed Scopus (129) Google Scholar ], AST/ALT being a misleading marker of disease severity [ [8] Portillo-Sanchez P. Bril F. Maximos M. Lomonaco R. Biernacki D. Orsak B. et al. High prevalence of nonalcoholic fatty liver disease in patients with type 2 diabetes mellitus and normal plasma aminotransferase levels. J Clin Endocrinol Metab. 2015; 100: 2231-2238 Crossref PubMed Scopus (333) Google Scholar ]. Results were also confounded by the lifestyle intervention (i.e., adoption of a low-fat diet, weight loss, and exercise) in at least in 2 of the post-hoc analyses [ 5 Athyros V.G. Giouleme O. Ganotakis E.S. Elisaf M. Tziomalos K. Vassiliadis T. et al. Safety and impact on cardiovascular events of long-term multifactorial treatment in patients with metabolic syndrome and abnormal liver function tests: a post hoc analysis of the randomised ATTEMPT study. Arch Med Sci. 2011; 7: 796-805 Crossref PubMed Scopus (93) Google Scholar , 6 Athyros V.G. Tziomalos K. Gossios T.D. Griva T. Anagnostis P. Kargiotis K. et al. Safety and efficacy of long-term statin treatment for cardiovascular events in patients with coronary heart disease and abnormal liver tests in the Greek Atorvastatin and Coronary Heart Disease Evaluation (GREACE) study: a post-hoc analysis. Lancet. 2010; 376: 1916-1922 Abstract Full Text Full Text PDF PubMed Scopus (559) Google Scholar ]. While neither the original nor post-hoc analysis of IDEAL [ [4] Tikkanen M.J. Fayyad R. Faergeman O. Olsson A.G. Wun C.C. Laskey R. et al. Effect of intensive lipid lowering with atorvastatin on cardiovascular outcomes in coronary heart disease patients with mild-to-moderate baseline elevations in alanine aminotransferase levels. Int J Cardiol. 2013; 168: 3846-3852 Abstract Full Text Full Text PDF PubMed Scopus (138) Google Scholar ] or GREACE [ [5] Athyros V.G. Giouleme O. Ganotakis E.S. Elisaf M. Tziomalos K. Vassiliadis T. et al. Safety and impact on cardiovascular events of long-term multifactorial treatment in patients with metabolic syndrome and abnormal liver function tests: a post hoc analysis of the randomised ATTEMPT study. Arch Med Sci. 2011; 7: 796-805 Crossref PubMed Scopus (93) Google Scholar ] reported on post-treatment changes in weight or metabolic parameters, ATTEMPT did show a 9% reduction in body weight with a significant reduction in fasting plasma glucose and an 85% net treatment effect decrease in the number of patients with metabolic syndrome and a 63% reduction in the presence of prediabetes [ [6] Athyros V.G. Tziomalos K. Gossios T.D. Griva T. Anagnostis P. Kargiotis K. et al. Safety and efficacy of long-term statin treatment for cardiovascular events in patients with coronary heart disease and abnormal liver tests in the Greek Atorvastatin and Coronary Heart Disease Evaluation (GREACE) study: a post-hoc analysis. Lancet. 2010; 376: 1916-1922 Abstract Full Text Full Text PDF PubMed Scopus (559) Google Scholar ]. Weight loss of ~5 to 9% alone can reduce plasma ALT concentration and even improve steatohepatitis [ [2] Diabetologia. 2016; 59: 1121-1140 Crossref PubMed Scopus (320) Google Scholar ]." @default.
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• W2532866276 title "Reply to “statins and non-alcoholic steatohepatitis”" @default.
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