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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\u003Cp id=\u0022p-1\u0022\u003EThe role of global coagulation assays in the clinical setting is unclear. Clinical trials are needed to further assess the relationship between global assays and clinical bleeding. Despite the promise of pharmacogenetics, evidence-based trials are needed to clarify the association between genotype and clinical outcomes, especially related to warfarin.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Epharmacogenetics\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ealgorithm\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eanticoagulation\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ewarfarin\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eassays\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ehemophilia\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECOX-2\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Edabigatran\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eclopidogrel\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Egenomics\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ehematology clinical trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\u003Cp id=\u0022p-2\u0022\u003EIn a session designed to review various aspects of anticoagulation tests and pharmacogenetics, Claude Negrier, MD, PhD, Universit\u00e9 Claude Bernard, Lyon, France, began by examining whether global assays can provide useful data in the clinical setting.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EHe reviewed traditional assays, such as activated partial prothrombin time and prothrombin time, which measure an activity of coagulation factors involved in the intrinsic and extrinsic pathways of coagulation, respectively. These 2 assays are inexpensive, widely used, validated, and typically automated. They can detect coagulation abnormalities and monitor anticoagulation levels in patients who take heparin or warfarin. However, these assays cannot be used to predict thrombotic risk or clinical bleeding phenotype among patients with some inherited bleeding disorders.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EIn 1 trial [Miller CH et al. \u003Cem\u003EJ Thromb Haemost\u003C\/em\u003E. 2013], patients with hemophilia were tested for factor VIII inhibitors through 3 clotting assays: modified Nijmegen-Bethesda Clotting Assay, a chromogenic Bethesda assay, and a novel fluorescence immunoassay\u2014the latter 2 of which were unable to demonstrate factor VIII specificity for 26% of 0.5 to 1.9 Nijmegen-Bethesda units.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EProf Negrier then discussed the challenges in assessing coagulation status in patients with inherited or acquired coagulation disorders. While activated partial prothrombin time and prothrombin time are able to identify hemostatic dysfunction involving the intrinsic, extrinsic, and common pathways of coagulation, they are not useful for assessment of hypercoagulability or fibrinolytic abnormalities. A more global approach to the coagulation system would reflect the complex interactions between the pro- and anticoagulant mechanisms that might better reflect clinical phenotypes and guide therapeutic interventions.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EMoving from anticoagulation to pharmacogenetics, Guillaume Par\u00e9, MD, McMaster University, Hamilton, Ontario, Canada, reviewed the role of pharmacogenetics in treating arterial disease. He began by discussing the FDA boxed warning on clopidogrel, which recommends that \u003Cem\u003ECYP2C19\u003C\/em\u003E genotyping be considered prior to the drug\u2019s prescription. A meta-analysis of 32 studies, however, suggested that whereas there was an association between the \u003Cem\u003ECYP2C19\u003C\/em\u003E genotype and clopidogrel responsiveness, overall there was no significant association of genotype with cardiovascular events [Holmes MV et al. \u003Cem\u003EJAMA\u003C\/em\u003E. 2011].\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EAccording to Prof Par\u00e9, there is a need for more evidence to determine the benefit of \u003Cem\u003ECYP2C19\u003C\/em\u003E testing before clopidogrel is prescribed. Because genetic testing has obvious costs and other risks, 1 option is to use an alternative antiplatelet agent such as ticagrelor, which appears to be more effective than standard-dose clopidogrel, irrespective of genotype [Par\u00e9 G, Eikelboom JW. \u003Cem\u003ECirc Cardiovasc Interv\u003C\/em\u003E. 2011; Wallentin L et al. \u003Cem\u003ELancet\u003C\/em\u003E. 2010]. He argued that there is no need for genotyping if the alternative treatment is superior to standard care, regardless of genetic results. A case for genotyping can be made if the results will change clinical management depending on genotype.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EProf Par\u00e9 then went on to discuss dabigatran. In the RE-LY trial [Connolly SJ et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E. 2009], a subsequent genome-wide association analysis identified 32.8% of patients with the minor allele rs2244613 (\u003Cem\u003ECES1\u003C\/em\u003E) [Par\u00e9 G et al. \u003Cem\u003ECirculation\u003C\/em\u003E. 2013]. This allele was associated with lower exposure to active dabigatran and a lower risk of bleeding as compared with patients who did not carry the allele (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E).\u003C\/p\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/21\/24\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Risk of Bleeding According to rs2244613 StatusReprinted from Par\u0026#xE9; G et al, Genetic determinants of dabigatran plasma levels and their relation to bleeding, Circulation, 2013, Vol 127, Issue 13, Pages 1404-12, with permission from American Heart Association, Inc.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-397866296\u0022 data-figure-caption=\u0022\u0026amp;lt;div xmlns=\u0026amp;quot;http:\/\/www.w3.org\/1999\/xhtml\u0026amp;quot;\u0026amp;gt;Risk of Bleeding According to rs2244613 StatusReprinted from Par\u0026#xE9; G et al, Genetic determinants of dabigatran plasma levels and their relation to bleeding, \u0026amp;lt;em\u0026amp;gt;Circulation\u0026amp;lt;\/em\u0026amp;gt;, 2013, Vol 127, Issue 13, Pages 1404-12, with permission from American Heart Association, Inc.\u0026amp;lt;\/div\u0026amp;gt;\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/21\/24\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/21\/24\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/15\/21\/24\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/16837\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \u003Cp id=\u0022p-9\u0022 class=\u0022first-child\u0022\u003ERisk of Bleeding According to rs2244613 Status\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EReprinted from Par\u00e9 G et al, Genetic determinants of dabigatran plasma levels and their relation to bleeding, \u003Cem\u003ECirculation\u003C\/em\u003E, 2013, Vol 127, Issue 13, Pages 1404-12, with permission from American Heart Association, Inc.\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-11\u0022\u003EProf Par\u00e9 then discussed cyclooxygenase-2 activity and the genetic variant rs20417 of the \u003Cem\u003EPTGS\u003C\/em\u003E2 gene. A detailed analysis of almost 50\u2005000 patients showed that the rs20417 variant was associated with a reduced risk of major cardiovascular events, especially in patients who took aspirin [Ross S et al. \u003Cem\u003EEur Heart J\u003C\/em\u003E. 2014].\u003C\/p\u003E\u003Cp id=\u0022p-12\u0022\u003EIn conclusion, Prof Par\u00e9 emphasized that despite the promise of pharmacogenetics, there is a need for evidence-based recommendations, especially related to clopidogrel. Pharmacogenetic effects can be population specific and possibly even tissue specific, and they must be incorporated into clinical trials.\u003C\/p\u003E\u003Cp id=\u0022p-13\u0022\u003EStephen E. Kimmel, MD, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA, then discussed genetic approaches to warfarin dosing. One nongenetic approach is to use fixed dosing; a second approach is to use clinical information to adjust the dose; and a third is to incorporate what we know about genetics alongside clinical information. In a validation cohort of 1009 patients from a larger cohort of 4043 patients who took 3 ranges of warfarin, a pharmacogenetic algorithm produced recommendations closer to the required therapeutic dose when compared with a fixed dose of 35 mg\/wk or a clinical algorithm [The International Warfarin Pharmacogenetics Consortium. \u003Cem\u003EN Engl J Med\u003C\/em\u003E. 2009]. These predictions were significantly better among patients who took the lowest (\u2264\u200521 mg\/wk) and highest (\u2265\u200549 mg\/wk) doses (\u003Cem\u003EP\u003C\/em\u003E\u2005\u0026lt;\u2005.001, both). In these 2 groups, the fixed dose never reached 20% of the actual stable therapeutic dose.\u003C\/p\u003E\u003Cp id=\u0022p-14\u0022\u003EDr Kimmel then went on to discuss whether pharmacogenetics will improve care of patients on warfarin. Because warfarin is a complex drug that is affected by pharmacokinetics, pharmacodynamics, target proteins, drug-drug interactions, adherence, and diet, it is not clear that pharmacogenetic dosing will improve outcomes. Therefore, research has turned to randomized trials to provide unbiased controlled comparisons of pharmacogenetic-based dosing of warfarin vs other strategies. The comparator group in these trials might include routine clinical care (fixed dose and clinician-determined empiric doses), a clinical algorithm (eg, dose, age, target INR, other medications, sex), or both.\u003C\/p\u003E\u003Cp id=\u0022p-15\u0022\u003EThe COAG trial [Kimmel SE et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E. 2013] compared a pharmacogenetic algorithm with a clinical dosing algorithm in patients on warfarin. At 4 weeks, there was no difference in the mean time that patients spent in therapeutic range. However, among African American patients, the mean percentage of time spent in the therapeutic range was higher in the clinical algorithm than the pharmacogenetic algorithm (\u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.03). Dr Kimmel also reviewed a genotype-guided trial suggesting no incremental benefit on anticoagulation control via \u003Cem\u003ECYP2CP\u003C\/em\u003E and \u003Cem\u003EVKORC1\u003C\/em\u003E to determine initial acenocoumarol or phenprocoumon dosing [Verhoef T et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E. 2013]. However, a pharmacogenetic algorithm was superior to an approach that incorporated fixed dosing by age instead of a formal clinical algorithm [Pirmohamed M et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E. 2013].\u003C\/p\u003E\u003Cp id=\u0022p-16\u0022\u003EDr Kimmel summed up his presentation with additional data from the COAG trial. The pharmacogenetic-guided algorithm was able to predict doses of warfarin within 1 mg\/d of maintenance dose compared with a hypothetical 5-mg\/d approach, while the clinical-guided strategy appeared to be particularly successful in African American patients (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E).\u003C\/p\u003E\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/16838\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/16838\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/16838\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \u003Cp id=\u0022p-17\u0022 class=\u0022first-child\u0022\u003EPredicted Dose of Warfarin Within 1 mg\/d of Maintenance Dose\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2015 SAGE Publications\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/15\/21\/24.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzlgu2\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzlgu2\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_tables.js?nzlgu2\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}