Clinical Effects of New Approach on Patients With Non-alcoholic Steatohepatitis

Summary

This study aims to evaluate and compare the protective outcomes of using Rosuvastatin, Vitamin E, and N-acetyl cysteine in Egyptian patients with NASH. The primary endpoint of this 6-month study would be an improved degree of fibrosis with no worsening of NASH or NASH resolution with no worsening of fibrosis and steatosis that the study considered successful if either 1ry endpoint is met. The secondary endpoint of this study is the improvement of biochemical markers related to steatosis, inflammation, oxidative stress, insulin resistance, and liver fibrosis.

Timeline

Start

2023-12-17

Primary completion

2024-06-17

Completion

2024-06-27

Publications

• Background El Hadi H, Vettor R, Rossato M. Vitamin E as a Treatment for Nonalcoholic Fatty Liver Disease: Reality or Myth? Antioxidants (Basel). 2018 Jan 16;7(1):12. doi: 10.3390/antiox7010012.
• Background Venetsanaki V, Karabouta Z, Polyzos SA. Farnesoid X nuclear receptor agonists for the treatment of nonalcoholic steatohepatitis. Eur J Pharmacol. 2019 Nov 15;863:172661. doi: 10.1016/j.ejphar.2019.172661. Epub 2019 Sep 16.
• Background Basaranoglu M, Basaranoglu G, Senturk H. From fatty liver to fibrosis: a tale of "second hit". World J Gastroenterol. 2013 Feb 28;19(8):1158-65. doi: 10.3748/wjg.v19.i8.1158.
• Background Tzanaki I, Agouridis AP, Kostapanos MS. Is there a role of lipid-lowering therapies in the management of fatty liver disease? World J Hepatol. 2022 Jan 27;14(1):119-139. doi: 10.4254/wjh.v14.i1.119.
• Background Ioannou GN, Van Rooyen DM, Savard C, Haigh WG, Yeh MM, Teoh NC, Farrell GC. Cholesterol-lowering drugs cause dissolution of cholesterol crystals and disperse Kupffer cell crown-like structures during resolution of NASH. J Lipid Res. 2015 Feb;56(2):277-85. doi: 10.1194/jlr.M053785. Epub 2014 Dec 17.
• Background Ahsan F, Oliveri F, Goud HK, Mehkari Z, Mohammed L, Javed M, Althwanay A, Rutkofsky IH. Pleiotropic Effects of Statins in the Light of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis. Cureus. 2020 Sep 14;12(9):e10446. doi: 10.7759/cureus.10446.
• Background Schierwagen R, Maybuchen L, Hittatiya K, Klein S, Uschner FE, Braga TT, Franklin BS, Nickenig G, Strassburg CP, Plat J, Sauerbruch T, Latz E, Lutjohann D, Zimmer S, Trebicka J. Statins improve NASH via inhibition of RhoA and Ras. Am J Physiol Gastrointest Liver Physiol. 2016 Oct 1;311(4):G724-G733. doi: 10.1152/ajpgi.00063.2016. Epub 2016 Sep 15.
• Background Kargiotis K, Katsiki N, Athyros VG, Giouleme O, Patsiaoura K, Katsiki E, Mikhailidis DP, Karagiannis A. Effect of rosuvastatin on non-alcoholic steatohepatitis in patients with metabolic syndrome and hypercholesterolaemia: a preliminary report. Curr Vasc Pharmacol. 2014 May;12(3):505-11. doi: 10.2174/15701611113119990009.
• Background Antonopoulos S, Mikros S, Mylonopoulou M, Kokkoris S, Giannoulis G. Rosuvastatin as a novel treatment of non-alcoholic fatty liver disease in hyperlipidemic patients. Atherosclerosis. 2006 Jan;184(1):233-4. doi: 10.1016/j.atherosclerosis.2005.08.021. Epub 2005 Oct 5. No abstract available.
• Background Gentric G, Maillet V, Paradis V, Couton D, L'Hermitte A, Panasyuk G, Fromenty B, Celton-Morizur S, Desdouets C. Oxidative stress promotes pathologic polyploidization in nonalcoholic fatty liver disease. J Clin Invest. 2015 Mar 2;125(3):981-92. doi: 10.1172/JCI73957. Epub 2015 Jan 26.
• Background Hutcheson R, Rocic P. The metabolic syndrome, oxidative stress, environment, and cardiovascular disease: the great exploration. Exp Diabetes Res. 2012;2012:271028. doi: 10.1155/2012/271028. Epub 2012 Jul 9.
• Background Ore A, Akinloye OA. Oxidative Stress and Antioxidant Biomarkers in Clinical and Experimental Models of Non-Alcoholic Fatty Liver Disease. Medicina (Kaunas). 2019 Jan 24;55(2):26. doi: 10.3390/medicina55020026.
• Background Van Herck MA, Weyler J, Kwanten WJ, Dirinck EL, De Winter BY, Francque SM, Vonghia L. The Differential Roles of T Cells in Non-alcoholic Fatty Liver Disease and Obesity. Front Immunol. 2019 Feb 6;10:82. doi: 10.3389/fimmu.2019.00082. eCollection 2019.
• Background de Andrade KQ, Moura FA, dos Santos JM, de Araujo OR, de Farias Santos JC, Goulart MO. Oxidative Stress and Inflammation in Hepatic Diseases: Therapeutic Possibilities of N-Acetylcysteine. Int J Mol Sci. 2015 Dec 18;16(12):30269-308. doi: 10.3390/ijms161226225.
• Background Dludla PV, Nkambule BB, Mazibuko-Mbeje SE, Nyambuya TM, Marcheggiani F, Cirilli I, Ziqubu K, Shabalala SC, Johnson R, Louw J, Damiani E, Tiano L. N-Acetyl Cysteine Targets Hepatic Lipid Accumulation to Curb Oxidative Stress and Inflammation in NAFLD: A Comprehensive Analysis of the Literature. Antioxidants (Basel). 2020 Dec 16;9(12):1283. doi: 10.3390/antiox9121283.
• Background Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, Sanyal AJ. The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018 Jan;67(1):328-357. doi: 10.1002/hep.29367. Epub 2017 Sep 29. No abstract available.
• Zakaria AY, Badawi R, Osama H, Abdelrahman MA, El-Kalaawy AM. New Approach Combination-Dosed Therapy for Nonalcoholic Steatohepatitis Versus Vitamin E: A Randomized Controlled Trial. Clin Ther. 2025 Aug;47(8):e19-e30. doi: 10.1016/j.clinthera.2025.05.006. Epub 2025 Jun 6.
• Zakaria AY, Badawi R, Osama H, Abdelrahman MA, El-Kalaawy AM. A Comparative Study of N-Acetyl Cysteine, Rosuvastatin, and Vitamin E in the Management of Patients with Non-Alcoholic Steatohepatitis: A Randomized Controlled Trial. Pharmaceuticals (Basel). 2025 Apr 29;18(5):650. doi: 10.3390/ph18050650.

Drugs

Indications