Trends in qualifying biomarkers in drug safety. Consensus of the 2011 meeting of the Spanish Society of Clinical Pharmacology

被引:12
作者
Agundez, Jose A. G. [1 ,2 ]
del Barrio, Jaime [3 ]
Padro, Teresa [4 ,5 ]
Stephens, Camilla [6 ,7 ]
Farre, Magi [8 ]
Andrade, Raul J. [7 ,9 ]
Badimon, Lina [4 ,5 ]
Garcia-Martin, Elena [2 ,10 ]
Vilahur, Gemma [4 ,5 ]
Isabel Lucena, M. [6 ,7 ]
机构
[1] Univ Extremadura, Dept Pharmacol, Avda Univ S-N, E-10071 Caceres, Spain
[2] Red Invest Reacciones Adversas Alergenos & Farm, Caceres, Spain
[3] Roche Inst, Madrid, Spain
[4] Biomed Res Inst St Pau, CSIC ICCC, Cardiovasc Res Ctr, Barcelona, Spain
[5] Ctr Invest Biomed Red Fisiopatol Obesidad & Nutr, Madrid, Spain
[6] Hosp Univ Virgen Victoria, Fac Med, Clin Pharmacol Serv, Malaga, Spain
[7] Ctr Invest Biomed Red Enfermedades Hepat & Digest, Barcelona, Spain
[8] Univ Autonoma Barcelona, Hosp Mar Res Inst IMIM, E-08193 Barcelona, Spain
[9] Hosp Univ Virgen Victoria, Fac Med, Liver Unit, Malaga, Spain
[10] Univ Extremadura, Dept Biochem & Mol Biol, E-10071 Caceres, Spain
来源
FRONTIERS IN PHARMACOLOGY | 2012年 / 3卷
关键词
biomarkers; pharmacogenomics; drug-induced liver injury; drug safety; PHARMACOGENETICS IMPLEMENTATION CONSORTIUM; INDUCED LIVER-INJURY; THIOPURINE METHYLTRANSFERASE; GENOTYPE; GUIDELINES; SUSCEPTIBILITY; POLYMORPHISMS; PHENOTYPE; MEDICINE; CYP2C19;
D O I
10.3389/fphar.2012.00002
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
In this paper we discuss the consensus view on the use of qualifying biomarkers in drug safety, raised within the frame of the XXIV meeting of the Spanish Society of Clinical Pharmacology held in Malaga (Spain) in October, 2011. The widespread use of biomarkers as surrogate endpoints is a goal that scientists have long been pursuing. Thirty years ago, when molecular pharmacogenomics evolved, we anticipated that these genetic biomarkers would soon obviate the routine use of drug therapies in a way that patients should adapt to the therapy rather than the opposite. This expected revolution in routine clinical practice never took place as quickly nor with the intensity as initially expected. The concerted action of operating multicenter networks holds great promise for future studies to identify biomarkers related to drug toxicity and to provide better insight into the underlying pathogenesis. Today some pharmacogenomic advances are already widely accepted, but pharmacogenomics still needs further development to elaborate more precise algorithms and many barriers to implementing individualized medicine exist. We briefly discuss our view about these barriers and we provide suggestions and areas of focus to advance in the field.
引用
收藏
页数:6
相关论文
共 32 条
[11]   Thiopurine S-methyltransferase genotype-phenotype concordance: used as a quality assurance tool to help control the phenotype assay [J].
Ford, Loretta ;
Kampanis, Petros ;
Berg, Jonathan .
ANNALS OF CLINICAL BIOCHEMISTRY, 2009, 46 :152-154
[12]   A single nucleotide polymorphism tags variation in the arylamine N-acetyltransferase 2 phenotype in populations of European background [J].
Garcia-Closas, Montserrat ;
Hein, David W. ;
Silverman, Debra ;
Malats, Nuria ;
Yeager, Meredith ;
Jacobs, Kevin ;
Doll, Mark A. ;
Figueroa, Jonine D. ;
Baris, Dalsu ;
Schwenn, Molly ;
Kogevinas, Manolis ;
Johnson, Alison ;
Chatterjee, Nilanjan ;
Moore, Lee E. ;
Moeller, Timothy ;
Real, Francisco X. ;
Chanock, Stephen ;
Rothman, Nathaniel .
PHARMACOGENETICS AND GENOMICS, 2011, 21 (04) :231-236
[13]   Charting a course for genomic medicine from base pairs to bedside [J].
Green, Eric D. ;
Guyer, Mark S. .
NATURE, 2011, 470 (7333) :204-213
[14]  
Groenen Peter Ma, 2011, Pharmacogenomics, V12, P1249, DOI 10.2217/pgs.11.82
[15]   Pharmacogenetic testing: not as simple as it seems [J].
Haga, Susanne B. ;
Burke, Wylie .
GENETICS IN MEDICINE, 2008, 10 (06) :391-395
[16]  
Institute of Medicine, 2011, PERSP BIOM SURR ENDP
[17]   Hepatotoxicity, a global problem with local features: toward the creation of a Pan-American Hepatotoxicity Network [J].
Isabel Lucena, Maria ;
Cohen, Henry ;
Hernandez, Nelia ;
Bessone, Fernando ;
Dacoll, Cristina ;
Stephens, Camilla ;
Borraz, Yolanda ;
Ulzurrun, Eugenia ;
Bruguera, Miguel ;
Andrade, Raul J. .
GASTROENTEROLOGIA Y HEPATOLOGIA, 2011, 34 (05) :361-368
[18]   Clinical Pharmacogenetics Implementation Consortium Guidelines for CYP2C9 and VKORC1 Genotypes and Warfarin Dosing [J].
Johnson, J. A. ;
Gong, L. ;
Whirl-Carrillo, M. ;
Gage, B. F. ;
Scott, S. A. ;
Stein, C. M. ;
Anderson, J. L. ;
Kimmel, S. E. ;
Lee, M. T. M. ;
Pirmohamed, M. ;
Wadelius, M. ;
Klein, T. E. ;
Altman, R. B. .
CLINICAL PHARMACOLOGY & THERAPEUTICS, 2011, 90 (04) :625-629
[19]   What Is Clinical Utility and Why Should We Care? [J].
Lesko, L. J. ;
Zineh, I. ;
Huang, S-M .
CLINICAL PHARMACOLOGY & THERAPEUTICS, 2010, 88 (06) :729-733
[20]   Glutathione S-transferase M1 and T1 null genotypes increase susceptibility to idiosyncratic drug-induced liver injury [J].
Lucena, M. Isabel ;
Andrade, Raul J. ;
Martinez, Carmen ;
Ulzurrun, Eugenia ;
Garcia-Martin, Elena ;
Borraz, Yolanda ;
Fernandez, M. Carmen ;
Romero-Gomez, Manuel ;
Castiella, Agustin ;
Planas, Ramon ;
Costa, Joan ;
Anzola, Sandra ;
Agundez, Jose A. G. .
HEPATOLOGY, 2008, 48 (02) :588-596