Saeid Sadeghi Joni1, Masoumeh Cheshmavar2, Pouria Shoureshi3, Zohreh Zamani4, Niusha Taoosi5, Morteza Akbari6, Mahdieh Afzali2. 1. Department of Radiology, Razi Hospital, Guilan University of Medical Sciences Rasht, Iran. 2. Department of Neurology, Isfahan University of Medical Sciences Isfahan, Iran. 3. Department of Internal Medicine, Orange Park Medical Center Florida, USA. 4. Department of Neurology, Firoozgar Hospital, Iran University of Medical Sciences Tehran, Iran. 5. Islamic University of Riau Riau, Indonesia. 6. School of Medicine, Isfahan University of Medical Sciences Isfahan, Iran.
Abstract
INTRODUCTION: Multiple Sclerosis (MS) is a chronic neurological disorder with no known cause or cure. Fingolimod (FTY720) is an oral medication recently approved for the treatment of MS as well as other diseases with autoimmune aspects. However, the drug is not without side effects. The severity and prevalence of these side effects are not completely understood. One of the most common causes for the patient cessation of fingolimod is an increase in liver enzymes, indicating possible inflammation or damage to liver cells. Alanine transaminase (ALT) and aspartate transaminase (AST) are the most common liver enzymes used as indicators of hepatic health. OBJECTIVES: This three-month prospective cohort study selected patients who were diagnosed with relapsing-remitting MS (RRMS) and who were not taking fingolimod oral treatment. ALT and AST levels were determined for these patients at baseline and then after three months of taking FTY720 to determine if these liver enzymes were changed. METHODS: 36 RRMS patients completed this study, which lasted three months. They were started on 0.5 oral FTY720 after approval from a physician and completion of an AST/ALT blood test. Baseline levels were determined and then taken again three months later. Statistical analysis of these values was performed using P<0.05 as a significance threshold. RESULTS: In this sample of patients, only ALT levels were significantly increased after fingolimod treatment in the general cohort (P=0.00). The general cohort showed an insignificant increase in AST levels. In male and female populations separately, AST was not significantly increased. ALT was only significantly increased in men (P=0.00) and insignificantly increased in women. CONCLUSION: This study further confirms our concerns about fingolimod's possible effects on the liver. While these numbers do support the claim that the drug does on average increase ALT in patient populations, it is important to note that most of these patients have no real hepatic side effects. In addition, previous studies have cited a return to normal ALT and AST levels after cessation of fingolimod, suggesting its effects are temporary and not severely damaged in the usual patient. IJPPP
INTRODUCTION:Multiple Sclerosis (MS) is a chronic neurological disorder with no known cause or cure. Fingolimod (FTY720) is an oral medication recently approved for the treatment of MS as well as other diseases with autoimmune aspects. However, the drug is not without side effects. The severity and prevalence of these side effects are not completely understood. One of the most common causes for the patient cessation of fingolimod is an increase in liver enzymes, indicating possible inflammation or damage to liver cells. Alanine transaminase (ALT) and aspartate transaminase (AST) are the most common liver enzymes used as indicators of hepatic health. OBJECTIVES: This three-month prospective cohort study selected patients who were diagnosed with relapsing-remitting MS (RRMS) and who were not taking fingolimod oral treatment. ALT and AST levels were determined for these patients at baseline and then after three months of taking FTY720 to determine if these liver enzymes were changed. METHODS: 36 RRMS patients completed this study, which lasted three months. They were started on 0.5 oral FTY720 after approval from a physician and completion of an AST/ALT blood test. Baseline levels were determined and then taken again three months later. Statistical analysis of these values was performed using P<0.05 as a significance threshold. RESULTS: In this sample of patients, only ALT levels were significantly increased after fingolimod treatment in the general cohort (P=0.00). The general cohort showed an insignificant increase in AST levels. In male and female populations separately, AST was not significantly increased. ALT was only significantly increased in men (P=0.00) and insignificantly increased in women. CONCLUSION: This study further confirms our concerns about fingolimod's possible effects on the liver. While these numbers do support the claim that the drug does on average increase ALT in patient populations, it is important to note that most of these patients have no real hepatic side effects. In addition, previous studies have cited a return to normal ALT and AST levels after cessation of fingolimod, suggesting its effects are temporary and not severely damaged in the usual patient. IJPPP
Authors: D Landi; S Vollaro; G Pellegrino; D Mulas; A Ghazaryan; E Falato; P Pasqualetti; P M Rossini; M M Filippi Journal: Clin Neurophysiol Date: 2014-06-19 Impact factor: 3.708
Authors: Massimo Filippi; Wolfgang Brück; Declan Chard; Franz Fazekas; Jeroen J G Geurts; Christian Enzinger; Simon Hametner; Tanja Kuhlmann; Paolo Preziosa; Àlex Rovira; Klaus Schmierer; Christine Stadelmann; Maria A Rocca Journal: Lancet Neurol Date: 2019-02 Impact factor: 44.182
Authors: Peter A Calabresi; Ernst-Wilhelm Radue; Douglas Goodin; Douglas Jeffery; Kottil W Rammohan; Anthony T Reder; Timothy Vollmer; Mark A Agius; Ludwig Kappos; Tracy Stites; Bingbing Li; Linda Cappiello; Philipp von Rosenstiel; Fred D Lublin Journal: Lancet Neurol Date: 2014-03-28 Impact factor: 44.182
Authors: Trina A Johnson; Barbara L Evans; Bryce A Durafourt; Manon Blain; Yves Lapierre; Amit Bar-Or; Jack P Antel Journal: J Immunol Date: 2011-05-27 Impact factor: 5.422
Authors: T Saida; S Kikuchi; Y Itoyama; Q Hao; T Kurosawa; K Nagato; D Tang; L Zhang-Auberson; J Kira Journal: Mult Scler Date: 2012-02-21 Impact factor: 6.312
Authors: Franz Fazekas; Thomas Berger; Tanja Hojs Fabjan; Alenka Horvat Ledinek; Gábor Jakab; Samuel Komoly; Jörg Kraus; Egon Kurča; Theodoros Kyriakides; L'ubomír Lisý; Ivan Milanov; Panayiotis Panayiotou; Sasa Sega Jazbec; Radomír Taláb; Latchezar Traykov; Peter Turčáni; Karl Vass; Norbert Vella; Eva Havrdová Journal: Wien Med Wochenschr Date: 2012-08-16