Comparison of Effectiveness of Obeticholic Acid With Vitamin E in Patients of Non-alcoholic Fatty Liver Disease

Summary

This study was conducted on patients presenting to Mayo Hospital, Lahore from 24th August, 2023 till 23rd May, 2024. Ninety patients conforming to the inclusion criteria were selected via simple random sampling technique and divided into two groups. Group A received Obeticholic acid 10mg once a day and Group B received Vitamin E 400mg twice a day. Both treatments were given for 6 months alongwith clear written and informed instructions regarding lifestyle modification. Patients were followed at 3 and 6 months with ultrasound abdomen and serum alanine transferase levels.

Timeline

Start

2023-08-24

Primary completion

2023-11-23

Completion

2024-05-23

Publications

• Background Rinella ME, Lominadze Z, Loomba R, Charlton M, Neuschwander-Tetri BA, Caldwell SH, Kowdley K, Harrison SA. Practice patterns in NAFLD and NASH: real life differs from published guidelines. Ther Adv Gastroenterol. 2016 Jan;9(1):4-12. doi: 10.1177/1756283X15611581.
• 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 Zhou J, Zhou F, Wang W, Zhang XJ, Ji YX, Zhang P, She ZG, Zhu L, Cai J, Li H. Epidemiological Features of NAFLD From 1999 to 2018 in China. Hepatology. 2020 May;71(5):1851-1864. doi: 10.1002/hep.31150.
• Background Roy PP, Mahtab MA, Rahim MA, Yesmin SS, Islam SB, Akbar SMF. Treatment of Nonalcoholic Steatohepatitis by Obeticholic Acid: Current Status. Euroasian J Hepatogastroenterol. 2022 Jul;12(Suppl 1):S46-S50. doi: 10.5005/jp-journals-10018-1360.
• Background Kamrul-Hasan A, Mondal S, Nagendra L, Sasikanth T, Ahammed A, Rahman S, Wickramarachchi A, Parajuli N, Khatiwada S, Dutta D. Role of Obeticholic Acid, a Farnesoid X Receptor Agonist, in Nonalcoholic Fatty Liver Disease: A Systematic Review and Meta-analysis. touchREV Endocrinol. 2024 Oct;20(2):54-61. doi: 10.17925/EE.2024.20.2.8. Epub 2024 Oct 9.
• Background 23. Abo Farrag GA, Afifi MA, El-Aziz SA, Ghoname MM, Ali AA. Role of Farnesoid X Receptor Ligand Obeticholic Acid Versus Vitamin E for Patients with Nonalcoholic Steatohepatitis. Al-Azhar International Medical Journal 2024; 5(10), Article 25. DOI: https://doi.org/10.58675/2682-339X.2706
• Background Karedath J, Javed H, Ahsan Talpur F, Lal B, Kumari A, Kivan H, Anirudh Chunchu V, Hirani S. Effect of Vitamin E on Clinical Outcomes in Patients With Non-alcoholic Fatty Liver Disease: A Meta-Analysis. Cureus. 2022 Dec 21;14(12):e32764. doi: 10.7759/cureus.32764. eCollection 2022 Dec.
• Background Zhao J, Li B, Zhang K, Zhu Z. The effect and safety of obeticholic acid for patients with nonalcoholic steatohepatitis: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2024 Feb 16;103(7):e37271. doi: 10.1097/MD.0000000000037271.
• Background 20. Aishwarya TS, Mounika N, Vishwakarma G, Adela R, Effect of obeticholic acid in non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) patients: a systematic review and meta-analysis, RPS Pharmacy and Pharmacology Reports, Volume 1, Issue 1, September 2022, rqac001, https://doi.org/10.1093/rpsppr/rqac001
• Background Paternostro R, Trauner M. Current treatment of non-alcoholic fatty liver disease. J Intern Med. 2022 Aug;292(2):190-204. doi: 10.1111/joim.13531. Epub 2022 Jul 7.
• Background Kulkarni AV, Tevethia HV, Arab JP, Candia R, Premkumar M, Kumar P, Sharma M, Reddy DN, Padaki NR. Efficacy and safety of obeticholic acid in liver disease-A systematic review and meta-analysis. Clin Res Hepatol Gastroenterol. 2021 May;45(3):101675. doi: 10.1016/j.clinre.2021.101675. Epub 2021 Mar 17.
• Background Li J, Zou B, Yeo YH, Feng Y, Xie X, Lee DH, Fujii H, Wu Y, Kam LY, Ji F, Li X, Chien N, Wei M, Ogawa E, Zhao C, Wu X, Stave CD, Henry L, Barnett S, Takahashi H, Furusyo N, Eguchi Y, Hsu YC, Lee TY, Ren W, Qin C, Jun DW, Toyoda H, Wong VW, Cheung R, Zhu Q, Nguyen MH. Prevalence, incidence, and outcome of non-alcoholic fatty liver disease in Asia, 1999-2019: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2019 May;4(5):389-398. doi: 10.1016/S2468-1253(19)30039-1. Epub 2019 Mar 20.
• Background Riazi K, Azhari H, Charette JH, Underwood FE, King JA, Afshar EE, Swain MG, Congly SE, Kaplan GG, Shaheen AA. The prevalence and incidence of NAFLD worldwide: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2022 Sep;7(9):851-861. doi: 10.1016/S2468-1253(22)00165-0. Epub 2022 Jul 5.
• Background Le MH, Yeo YH, Li X, Li J, Zou B, Wu Y, Ye Q, Huang DQ, Zhao C, Zhang J, Liu C, Chang N, Xing F, Yan S, Wan ZH, Tang NSY, Mayumi M, Liu X, Liu C, Rui F, Yang H, Yang Y, Jin R, Le RHX, Xu Y, Le DM, Barnett S, Stave CD, Cheung R, Zhu Q, Nguyen MH. 2019 Global NAFLD Prevalence: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2809-2817.e28. doi: 10.1016/j.cgh.2021.12.002. Epub 2021 Dec 7.
• Background Bril F, Biernacki DM, Kalavalapalli S, Lomonaco R, Subbarayan SK, Lai J, Tio F, Suman A, Orsak BK, Hecht J, Cusi K. Role of Vitamin E for Nonalcoholic Steatohepatitis in Patients With Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2019 Aug;42(8):1481-1488. doi: 10.2337/dc19-0167. Epub 2019 May 21.
• Background Hindson J. Obeticholic acid for the treatment of NASH. Nat Rev Gastroenterol Hepatol. 2020 Feb;17(2):66. doi: 10.1038/s41575-020-0264-1. No abstract available.
• Background Amanullah I, Khan YH, Anwar I, Gulzar A, Mallhi TH, Raja AA. Effect of vitamin E in non-alcoholic fatty liver disease: a systematic review and meta-analysis of randomised controlled trials. Postgrad Med J. 2019 Nov;95(1129):601-611. doi: 10.1136/postgradmedj-2018-136364. Epub 2019 Aug 21.
• Background Perumpail BJ, Li AA, John N, Sallam S, Shah ND, Kwong W, Cholankeril G, Kim D, Ahmed A. The Role of Vitamin E in the Treatment of NAFLD. Diseases. 2018 Sep 24;6(4):86. doi: 10.3390/diseases6040086.
• Background Younossi ZM, Ratziu V, Loomba R, Rinella M, Anstee QM, Goodman Z, Bedossa P, Geier A, Beckebaum S, Newsome PN, Sheridan D, Sheikh MY, Trotter J, Knapple W, Lawitz E, Abdelmalek MF, Kowdley KV, Montano-Loza AJ, Boursier J, Mathurin P, Bugianesi E, Mazzella G, Olveira A, Cortez-Pinto H, Graupera I, Orr D, Gluud LL, Dufour JF, Shapiro D, Campagna J, Zaru L, MacConell L, Shringarpure R, Harrison S, Sanyal AJ; REGENERATE Study Investigators. Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial. Lancet. 2019 Dec 14;394(10215):2184-2196. doi: 10.1016/S0140-6736(19)33041-7. Epub 2019 Dec 5.
• Background Zhang DY, Zhu L, Liu HN, Tseng YJ, Weng SQ, Liu TT, Dong L, Shen XZ. The protective effect and mechanism of the FXR agonist obeticholic acid via targeting gut microbiota in non-alcoholic fatty liver disease. Drug Des Devel Ther. 2019 Jul 5;13:2249-2270. doi: 10.2147/DDDT.S207277. eCollection 2019.
• Background Neuschwander-Tetri BA, Loomba R, Sanyal AJ, Lavine JE, Van Natta ML, Abdelmalek MF, Chalasani N, Dasarathy S, Diehl AM, Hameed B, Kowdley KV, McCullough A, Terrault N, Clark JM, Tonascia J, Brunt EM, Kleiner DE, Doo E; NASH Clinical Research Network. Farnesoid X nuclear receptor ligand obeticholic acid for non-cirrhotic, non-alcoholic steatohepatitis (FLINT): a multicentre, randomised, placebo-controlled trial. Lancet. 2015 Mar 14;385(9972):956-65. doi: 10.1016/S0140-6736(14)61933-4. Epub 2014 Nov 7.
• Background Attia SL, Softic S, Mouzaki M. Evolving Role for Pharmacotherapy in NAFLD/NASH. Clin Transl Sci. 2021 Jan;14(1):11-19. doi: 10.1111/cts.12839. Epub 2020 Aug 25.
• Background Mundi MS, Velapati S, Patel J, Kellogg TA, Abu Dayyeh BK, Hurt RT. Evolution of NAFLD and Its Management. Nutr Clin Pract. 2020 Feb;35(1):72-84. doi: 10.1002/ncp.10449. Epub 2019 Dec 16.
• Background Huang DQ, Singal AG, Kono Y, Tan DJH, El-Serag HB, Loomba R. Changing global epidemiology of liver cancer from 2010 to 2019: NASH is the fastest growing cause of liver cancer. Cell Metab. 2022 Jul 5;34(7):969-977.e2. doi: 10.1016/j.cmet.2022.05.003. Epub 2022 Jun 3.
• Background Tan DJH, Setiawan VW, Ng CH, Lim WH, Muthiah MD, Tan EX, Dan YY, Roberts LR, Loomba R, Huang DQ. Global burden of liver cancer in males and females: Changing etiological basis and the growing contribution of NASH. Hepatology. 2023 Apr 1;77(4):1150-1163. doi: 10.1002/hep.32758. Epub 2022 Sep 12.

Drugs

Indications