Managing the Risk of Drug-Induced Liver Injury

被引:9
作者
Watkins, P. B. [1 ,2 ,3 ]
机构
[1] Univ N Carolina, Hamner Univ North Carolina Inst Drug Safety Sci, Chapel Hill, NC 27515 USA
[2] Univ N Carolina, Dept Med, Chapel Hill, NC USA
[3] Univ N Carolina, Sch Pharm, Dept Pharmacotherapy & Expt Therapeut, Chapel Hill, NC USA
关键词
GENOME-WIDE; BOSENTAN; ASSOCIATION;
D O I
10.1038/clpt.2013.182
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
In clinical trials, bosentan was shown to cause significant drug-induced liver injury (DILI) in some patients. Because it is not possible to identify those at higher risk for DILI, all patients to be treated with bosentan must enroll in a program requiring documentation of liver blood testing before they can receive the drug. Because this program is costly and is perceived as onerous, a genetic test capable of identifying susceptible individuals would probably be rapidly adopted by physicians.
引用
收藏
页码:629 / 631
页数:3
相关论文
共 11 条
[1]  
Actelion Pharmaceuticals, 2001, BRIEF DOC TRACL BOS
[2]  
[Anonymous], 2013, GUID IND CLIN PHARM
[3]   Effects of the dual endothelin-receptor antagonist bosentan in patients with pulmonary hypertension: a randomised placebo-controlled study [J].
Channick, RN ;
Simonneau, G ;
Sitbon, O ;
Robbins, IM ;
Frost, A ;
Tapson, VF ;
Badesch, DB ;
Roux, S ;
Rainisio, M ;
Bodin, F ;
Rubin, LJ .
LANCET, 2001, 358 (9288) :1119-1123
[4]   Using Genome-Wide Association Studies to Identify Genes Important in Serious Adverse Drug Reactions [J].
Daly, Ann K. .
ANNUAL REVIEW OF PHARMACOLOGY AND TOXICOLOGY, VOL 52, 2012, 52 :21-35
[5]  
Drug-Induced Liver Injury Network, ANC STUD
[6]   Association of CYP2C9*2 With Bosentan-Induced Liver Injury [J].
Markova, S. M. ;
De Marco, T. ;
Bendjilali, N. ;
Kobashigawa, E. A. ;
Mefford, J. ;
Sodhi, J. ;
Le, H. ;
Zhang, C. ;
Halladay, J. ;
Rettie, A. E. ;
Khojasteh, C. ;
McGlothlin, D. ;
Wu, A. H. B. ;
Hsueh, W-C ;
Witte, J. S. ;
Schwartz, J. B. ;
Kroetz, D. L. .
CLINICAL PHARMACOLOGY & THERAPEUTICS, 2013, 94 (06) :678-686
[7]   Bosentan therapy for pulmonary arterial hypertension [J].
Rubin, LJ ;
Badesch, DB ;
Barst, RJ ;
Galiè, N ;
Black, CM ;
Keogh, A ;
Pulido, T ;
Frost, A ;
Roux, S ;
Leconte, I ;
Landzberg, M ;
Simonneau, G .
NEW ENGLAND JOURNAL OF MEDICINE, 2002, 346 (12) :896-903
[8]   Risk management strategies in the postmarketing period - Safety experience with the US and European bosentan surveillance programmes [J].
Segal, ES ;
Valette, C ;
Oster, L ;
Bouley, L ;
Edfjall, C ;
Herrmann, P ;
Raineri, M ;
Kempff, M ;
Beacham, S ;
van Lierop, C .
DRUG SAFETY, 2005, 28 (11) :971-980
[9]   A genome-wide study identifies HLA alleles associated with lumiracoxib-related liver injury [J].
Singer, Jonathan B. ;
Lewitzky, Steve ;
Leroy, Elisabeth ;
Yang, Fan ;
Zhao, Xiaojun ;
Klickstein, Lloyd ;
Wright, Timothy M. ;
Meyer, Joanne ;
Paulding, Charles A. .
NATURE GENETICS, 2010, 42 (08) :711-U94
[10]   HLA-DQA1*02:01 Is a Major Risk Factor for Lapatinib-Induced Hepatotoxicity in Women With Advanced Breast Cancer [J].
Spraggs, Colin F. ;
Budde, Laura R. ;
Briley, Linda P. ;
Bing, Nan ;
Cox, Charles J. ;
King, Karen S. ;
Whittaker, John C. ;
Mooser, Vincent E. ;
Preston, Alaknanda J. ;
Stein, Steven H. ;
Cardon, Lon R. .
JOURNAL OF CLINICAL ONCOLOGY, 2011, 29 (06) :667-673