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<div class="pre-content"><div><div class="bk_prnt"><p class="small">NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.</p><p>LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. </p></div><div class="iconblock clearfix whole_rhythm no_top_margin bk_noprnt"><a class="img_link icnblk_img" title="All Drug Records" href="/books/n/livertox/"><img class="source-thumb" src="/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-livertox-lrg.png" alt="Cover of LiverTox" height="100px" width="80px" /></a><div class="icnblk_cntnt eight_col"><h2>LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet].</h2><a data-jig="ncbitoggler" href="#__NBK548805_dtls__">Show details</a><div style="display:none" class="ui-widget" id="__NBK548805_dtls__"><div>Bethesda (MD): <a href="https://www.niddk.nih.gov/" ref="pagearea=page-banner&targetsite=external&targetcat=link&targettype=publisher">National Institute of Diabetes and Digestive and Kidney Diseases</a>; 2012-.</div></div><div class="half_rhythm"><ul class="inline_list"><li style="margin-right:1em"><a class="bk_cntns" href="/books/n/livertox/">Drug Records</a></li></ul></div><div class="bk_noprnt"><form method="get" action="/books/n/livertox/" id="bk_srch"><div class="bk_search"><label for="bk_term" class="offscreen_noflow">Search term</label><input type="text" title="Search this book" id="bk_term" name="term" value="" data-jig="ncbiclearbutton" /> <input type="submit" class="jig-ncbibutton" value="Search this book" submit="false" style="padding: 0.1em 0.4em;" /></div></form></div></div><div class="icnblk_cntnt two_col"><div class="pagination bk_noprnt"><a class="active page_link prev" href="/books/n/livertox/Edaravone/" title="Previous page in this title">< Prev</a><a class="active page_link next" href="/books/n/livertox/Efalizumab/" title="Next page in this title">Next ></a></div></div></div></div></div>
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<div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><h1 id="_NBK548805_"><span class="title" itemprop="name">Edoxaban</span></h1><p class="small">Last Update: <span itemprop="dateModified">February 16, 2023</span>.</p></div><div class="body-content whole_rhythm" itemprop="text"><div id="Edoxaban.OVERVIEW"><h2 id="_Edoxaban_OVERVIEW_">OVERVIEW</h2><div id="Edoxaban.Introduction"><h3>Introduction</h3><p>Edoxaban is an oral, small molecule inhibitor of factor Xa which is used as an anticoagulant to decrease the risk of venous thromboses, systemic embolization and stroke in patients with atrial fibrillation, and as treatment of deep vein thrombosis and pulmonary embolism. Edoxaban has been linked to a low rate of serum aminotransferase elevations during therapy and to rare instances of clinically apparent acute liver injury.</p></div><div id="Edoxaban.Background"><h3>Background</h3><p>Edoxaban (e dox' a ban) is a selective inhibitor of the coagulation factor Xa, the last and rate controlling step in the generation of thrombin, the final intermediate in blood coagulation. Inhibiting thrombin prevents the conversion of fibrinogen to fibrin and subsequent cross linking of fibrin monomers, platelet activation and amplification of coagulation activation. Edoxaban has been shown to be as effective an anticoagulant as warfarin in preventing stroke and systemic embolization in patients with atrial fibrillation. Clinical trials have also shown that edoxaban can decrease the risk of complications of deep vein thrombosis and pulmonary embolism. Edoxaban was approved for use in the United States in 2015, the third direct factor Xa inhibitor to be approved. Current indications are for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation and for treatment of patients with deep vein thrombosis and pulmonary embolism. Edoxaban is not recommended in patients with a creatinine clearance of greater than 95 cc/minute as such patients had increases in ischemic strokes compare to patients treated with warfarin. Edoxaban is available in 15, 30 and 60 mg tablets under the commercial name Savaysa. The usual dose is 60 mg daily. Unlike warfarin, edoxaban and the other oral direct thrombin and factor Xa inhibitors do not require monitoring of bleeding time or INR and rarely require dose adjustments. Side effects are not common, but can include bleeding, headache, gastrointestinal upset, and rash. Rare, but potential severe adverse reactions include major bleeding including hemorrhagic stroke as well as spinal or epidural hematomas, and increased risk of ischemic events in patients with premature discontinuation.</p></div><div id="Edoxaban.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>Edoxaban is associated with serum aminotransferase elevations greater than 3 times the upper limit of normal in 2% to 5% of treated patients. This rate is similar or lower than rates with warfarin or comparator arms. The elevations are generally transient and not associated with symptoms or jaundice. In premarketing studies, no instances of clinically apparent liver injury were reported, but there was little experience in large numbers of patients treated for extend periods of time. In large health care databases, the rate of liver injury has been somewhat less with edoxaban than rivaroxaban and apixaban, but the numbers of patients treated with edoxaban has been limited and the nature of the liver injury not described.</p><p><a class="def" href="/books/n/livertox/glossary/def-item/glossary.likelihood-score/">Likelihood score</a>: D (possible race cause of clinically apparent liver injury).</p></div><div id="Edoxaban.Mechanism_of_Injury"><h3>Mechanism of Injury</h3><p>Edoxaban is eliminated largely unchanged in the urine and has minimal hepatic metabolism. It is a substrate of P-glycoprotein, and its serum concentrations can be affected by inducers (rifampin) and inhibitors of this transport protein. The cause of the serum enzyme elevations during therapy with edoxaban is unknown, but the rate of such elevations was usually lower or no different than with comparator anticoagulants.</p></div><div id="Edoxaban.Outcome_and_Management"><h3>Outcome and Management</h3><p>The serum enzyme elevations during edoxaban therapy have been mild-to-moderate in severity, but asymptomatic and rapidly reversible often even without stopping therapy. Clinically apparent liver injury due to edoxaban appears to be rare and has not been well documented. There is no reason to suspect that there is cross sensitivity to hepatic injury among the various anticoagulants including other factor Xa inhibitors.</p><p>Drug Class: <a href="/books/n/livertox/Anticoagulants/">Antithrombotic Agents</a>, <a href="/books/n/livertox/Anticoagulants/">Anticoagulants</a></p><p>Other Drugs in the Subclass, Anticoagulants, Newer Direct Oral Anticoagulants: <a href="/books/n/livertox/Apixaban/">Apixaban</a>, <a href="/books/n/livertox/Betrixaban/">Betrixaban</a>, <a href="/books/n/livertox/Fondaparinux/">Fondaparinux</a>, <a href="/books/n/livertox/Rivaroxaban/">Rivaroxaban</a></p></div></div><div id="Edoxaban.PRODUCT_INFORMATION"><h2 id="_Edoxaban_PRODUCT_INFORMATION_">PRODUCT INFORMATION</h2><p>
|
||
<b>REPRESENTATIVE TRADE NAMES</b>
|
||
</p><p>Edoxaban – Savaysa®</p><p>
|
||
<b>DRUG CLASS</b>
|
||
</p><p>Anticoagulants</p><p>
|
||
<a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Edoxaban" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">COMPLETE LABELING</a>
|
||
</p><p>Product labeling at DailyMed, National Library of Medicine, NIH</p></div><div id="Edoxaban.CHEMICAL_FORMULAS_AND_STRUCTURE"><h2 id="_Edoxaban_CHEMICAL_FORMULAS_AND_STRUCTURE_">CHEMICAL FORMULAS AND STRUCTURES</h2><div id="Edoxaban.Tc" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK548805/table/Edoxaban.Tc/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__Edoxaban.Tc_lrgtbl__"><table><thead><tr><th id="hd_h_Edoxaban.Tc_1_1_1_1" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">DRUG</th><th id="hd_h_Edoxaban.Tc_1_1_1_2" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CAS REGISTRY NO.</th><th id="hd_h_Edoxaban.Tc_1_1_1_3" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MOLECULAR FORMULA</th><th id="hd_h_Edoxaban.Tc_1_1_1_4" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">STRUCTURE</th></tr></thead><tbody><tr><td headers="hd_h_Edoxaban.Tc_1_1_1_1" scope="row" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Edoxaban</td><td headers="hd_h_Edoxaban.Tc_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
||
<a href="https://pubchem.ncbi.nlm.nih.gov/substance/135263753" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem">480449-70-5</a>
|
||
</td><td headers="hd_h_Edoxaban.Tc_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">C24-H30-Cl-N7-O4-S</td><td headers="hd_h_Edoxaban.Tc_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">SID:135263753</td></tr></tbody></table></div></div></div><div id="Edoxaban.ANNOTATED_BIBLIOGRAPHY"><h2 id="_Edoxaban_ANNOTATED_BIBLIOGRAPHY_">ANNOTATED BIBLIOGRAPHY</h2><p>References updated: 16 February 2023</p><ul class="first-line-outdent"><li><div class="bk_ref" id="Edoxaban.REF.zimmerman.1999">Zimmerman HJ. Antithrombotic agents. Drugs used in cardiovascular disease. In, Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999, pp. 639-42.<div><i>(Textbook of hepatotoxicity published in 1999, well before the availability of edoxaban and the direct factor Xa inhibitors).</i></div></div></li><li><div class="bk_ref" id="Edoxaban.REF.de_marzio.2013">De Marzio DH, Navarro VJ. Hepatotoxicity of cardiovascular and antidiabetic drugs: antihypertensives. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier, 2013, p. 519-53.<div><i>(Review of hepatotoxicity of cardiovascular drugs does not discuss the anticoagulants).</i></div></div></li><li><div class="bk_ref" id="Edoxaban.REF.weitz.2011">Weitz JI. Blood coagulation and anticoagulant, fibrinolytic, and antiplatelet drugs. In, Brunton LL, Chabner BA, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 12th ed. New York: McGraw-Hill, 2011, pp. 849-76.<div><i>(Textbook of pharmacology and therapeutics).</i></div></div></li><li><div class="bk_ref" id="Edoxaban.REF.reuben.2010.2065">Reuben A, Koch DG, Lee WM., Acute Liver Failure Study Group. Drug-induced acute liver failure: results of a U.S. multicenter, prospective study. <span><span class="ref-journal">Hepatology. </span>2010;<span class="ref-vol">52</span>:2065–76.</span> [<a href="/pmc/articles/PMC3992250/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC3992250</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/20949552" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20949552</span></a>]<div>
|
||
<i>(Among 1198 patients with acute liver failure enrolled in a US prospective study between 1998 and 2007, 133 were attributed to drug induced liver injury, but none were due to anticoagulants).</i>
|
||
</div></div></li><li><div class="bk_ref" id="Edoxaban.REF.weitz.2010.633">Weitz JI, Connolly SJ, Patel I, Salazar D, Rohatagi S, Mendell J, Kastrissios H, et al. Randomised, parallel-group, multicentre, multinational phase 2 study comparing edoxaban, an oral factor Xa inhibitor, with warfarin for stroke prevention in patients with atrial fibrillation. <span><span class="ref-journal">Thromb Haemost. </span>2010;<span class="ref-vol">104</span>:633–41.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/20694273" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20694273</span></a>]<div>
|
||
<i>(Among 1,146 patients with atrial fibrillation and risk of stroke who were treated with edoxaban [varying regimens] or warfarin for 3 months, rates of stroke were similar in all groups and ALT elevations occurred in 15 of 866 [1.7%] on edoxaban and 4 of 245 [1.6%] on warfarin; concurrent ALT, Alk P and bilirubin elevations in 2 edoxaban treated subjects were attributed to other conditions [gallstones and heart failure]).</i>
|
||
</div></div></li><li><div class="bk_ref" id="Edoxaban.REF.raskob.2010.642">Raskob G, Cohen AT, Eriksson BI, Puskas D, Shi M, Bocanegra T, Weitz JI. Oral direct factor Xa inhibition with edoxaban for thromboprophylaxis after elective total hip replacement. A randomised double-blind dose-response study. <span><span class="ref-journal">Thromb Haemost. </span>2010;<span class="ref-vol">104</span>:642–9.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/20589317" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20589317</span></a>]<div>
|
||
<i>(Among 903 patients undergoing hip replacement who received either edoxaban [15, 30, 60 or 90 mg daily] or dalteparin for 7 to 10 days, rates of venous thromboembolism was less with edoxaban [11-20%] than dalteparin [44%], while rates of ALT elevations above 3 times ULN were similar [2.4-4.3% vs 2.9%]).</i>
|
||
</div></div></li><li><div class="bk_ref" id="Edoxaban.REF7">Treatment of atrial fibrillation. <span><span class="ref-journal">Treat Guidel Med Lett. </span>2010;<span class="ref-vol">8</span>(97):65–70.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/20733547" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20733547</span></a>]<div>
|
||
<i>(Concise review of treatment of atrial fibrillation including use of apixaban and rivaroxaban; does not mention hepatotoxicity or ALT elevations).</i>
|
||
</div></div></li><li><div class="bk_ref" id="Edoxaban.REF.hokusaivte_investigators.2013.1406">Hokusai-VTE Investigators. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. <span><span class="ref-journal">N Engl J Med. </span>2013;<span class="ref-vol">369</span>:1406–15.</span> Büller HR, Décousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, et al. [<a href="https://pubmed.ncbi.nlm.nih.gov/23991658" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 23991658</span></a>]<div>
|
||
<i>(Among 4921 patients with deep venous thrombosis and 3319 with pulmonary embolism treated with edoxaban [30 or 60 mg daily] of warfarin for 3 to 12 months, recurrent thromboembolism was similar with either agent [3.2% vs 3.5%], as were adverse events with ALT elevations above 3 times ULN in 2.1% vs 2.3%, concurrent ALT and bilirubin elevations in 0.2% vs 0.1%, and no instance of a serious hepatic adverse event).</i>
|
||
</div></div></li><li><div class="bk_ref" id="Edoxaban.REF.fuji.2014.1198">Fuji T, Wang CJ, Fujita S, Kawai Y, Nakamura M, Kimura T, Ibusuki K, et al. Safety and efficacy of edoxaban, an oral factor Xa inhibitor, versus enoxaparin for thromboprophylaxis after total knee arthroplasty: the STARS E-3 trial. <span><span class="ref-journal">Thromb Res. </span>2014;<span class="ref-vol">134</span>:1198–204.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/25294589" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25294589</span></a>]<div>
|
||
<i>(Among 594 patients undergoing hip replacement treated with either edoxaban or enoxaparin for 11-14 days, thromboembolism occurred in 7% vs 14%, while ALT elevations above 3 times ULN occurred in 0.6% vs 6%).</i>
|
||
</div></div></li><li><div class="bk_ref" id="Edoxaban.REF10">New oral anticoagulants for acute venous thromboembolism. <span><span class="ref-journal">Med Lett Drugs Ther. </span>2014;<span class="ref-vol">56</span>(1433):3–4.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/24419296" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 24419296</span></a>]<div>
|
||
<i>(Brief comparison of warfarin, rivaroxaban, apixaban and dabigatran as anticoagulants for therapy of venous thromboembolism, all of which have similar efficacy, warfarin requiring regular monitoring of INR whereas the others do not).</i>
|
||
</div></div></li><li><div class="bk_ref" id="Edoxaban.REF.caldeira.2014.550">Caldeira D, Barra M, Santos AT, de Abreu D, Pinto FJ, Ferreira JJ, Costa J. Risk of drug-induced liver injury with the new oral anticoagulants: systematic review and meta-analysis. <span><span class="ref-journal">Heart. </span>2014;<span class="ref-vol">100</span>:550–6.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/24476812" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 24476812</span></a>]<div>
|
||
<i>(Systematic review of 29 controlled trials of oral anticoagulants in 152,116 patients focusing on risk of drug induced liver injury [including 1 trial with 3878 patients on edoxaban] found no increase in rate of serum ALT or AST elevations above 3 times ULN [2.1% vs 2.3%] or combined enzyme and bilirubin elevations above 2 times ULN [0.2% vs 0.08%] with edoxaban therapy compared to control patients on warfarin, and concludes that the direct Factor Xa inhibitors "do not increase the risk of DILI").</i>
|
||
</div></div></li><li><div class="bk_ref" id="Edoxaban.REF.fuji.2015.27">Fuji T, Fujita S, Kawai Y, Nakamura M, Kimura T, Fukuzawa M, Abe K, Tachibana S. Efficacy and safety of edoxaban versus enoxaparin for the prevention of venous thromboembolism following total hip arthroplasty: STARS J-V. <span><span class="ref-journal">Thromb J. </span>2015;<span class="ref-vol">13</span>:27.</span> [<a href="/pmc/articles/PMC4534125/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4534125</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/26269694" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26269694</span></a>]<div>
|
||
<i>(Among 610 patients undergoing hip replacement who were treated with edoxaban [30 mg daily] or enoxaparin [subcutaneously twice daily] for 11-14 days, venous thromboembolism events occurred in 2.4% vs 6.9% with no increase in bleeding episodes, and ALT elevations in 12% vs 42%, being above 3 times ULN in 3.3% vs 13.7%).</i>
|
||
</div></div></li><li><div class="bk_ref" id="Edoxaban.REF.liakoni.2015.711">Liakoni E, Rätz Bravo AE, Krähenbühl S. Hepatotoxicity of new oral anticoagulants (NOACs). <span><span class="ref-journal">Drug Saf. </span>2015;<span class="ref-vol">38</span>:711–20.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/26138527" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26138527</span></a>]<div>
|
||
<i>(Review of published literature and data from pharmacovigilance registries on liver injury due to new oral anticoagulants including edoxaban, apixaban and rivaroxaban concludes that hepatotoxicity is possible with these agents, but is rare and does not warrant routine monitoring).</i>
|
||
</div></div></li><li><div class="bk_ref" id="Edoxaban.REF.chalasani.2015.1340">Chalasani N, Bonkovsky HL, Fontana R, Lee W, Stolz A, Talwalkar J, Reddy KR, et al. United States Drug Induced Liver Injury Network. Features and outcomes of 899 patients with drug-induced liver injury: The DILIN Prospective Study. <span><span class="ref-journal">Gastroenterology. </span>2015;<span class="ref-vol">148</span>:1340–52.e7.</span> [<a href="/pmc/articles/PMC4446235/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4446235</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/25754159" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25754159</span></a>]<div>
|
||
<i>(Among 899 cases of drug induced liver injury enrolled in a US prospective study between 2004 and 2013, two were attributed to antithrombotic agents [prasugrel and dalteparin], but none to edoxaban or other direct factor Xa inhibitors).</i>
|
||
</div></div></li><li><div class="bk_ref" id="Edoxaban.REF15">Edoxaban (Savaysa)--the fourth new oral anticoagulant. <span><span class="ref-journal">Med Lett Drugs Ther. </span>2015;<span class="ref-vol">57</span>(1465):43–5.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/25853577" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25853577</span></a>]<div>
|
||
<i>(Concise review of efficacy and safety of edoxaban for prevention of stroke or systemic embolization in patients with nonvalvular atrial fibrillation, which is equivalent or better in efficacy than warfarin with a lower rate of bleeding; no mention of hepatotoxicity or ALT elevations).</i>
|
||
</div></div></li><li><div class="bk_ref" id="Edoxaban.REF.kawai.2016.48">Kawai Y, Fuji T, Fujita S, Kimura T, Ibusuki K, Abe K, Tachibana S. Edoxaban versus enoxaparin for the prevention of venous thromboembolism after total knee or hip arthroplasty: pooled analysis of coagulation biomarkers and primary efficacy and safety endpoints from two phase 3 trials. <span><span class="ref-journal">Thromb J. </span>2016;<span class="ref-vol">14</span>:48.</span> [<a href="/pmc/articles/PMC5134224/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5134224</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/27980462" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27980462</span></a>]<div>
|
||
<i>(Among 716 patients undergoing total knee replacement in two trials in Asia comparing edoxaban to enoxaparin given for 11-14 days, thromboembolic events were less common with edoxaban [5% vs 11] while bleeding and other adverse event rates were similar; no mention of ALT elevations or hepatotoxicity).</i>
|
||
</div></div></li><li><div class="bk_ref" id="Edoxaban.REF.goette.2016.1995">Goette A, Merino JL, Ezekowitz MD, Zamoryakhin D, Melino M, Jin J, Mercuri MF, et al. ENSURE-AF investigators. Edoxaban versus enoxaparin-warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial. <span><span class="ref-journal">Lancet. </span>2016;<span class="ref-vol">388</span>(10055):1995–2003.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/27590218" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27590218</span></a>]<div>
|
||
<i>(Among 2199 patients with atrial fibrillation undergoing cardioversion treated with edoxaban or enoxaparin-warfarin, major thrombotic events were rare [<1% vs 1%] as were major bleeding episodes [<1% vs <1%] and overall adverse event rates [30% vs 33%]; no mention of ALT elevations or hepatotoxicity).</i>
|
||
</div></div></li><li><div class="bk_ref" id="Edoxaban.REF.conway.2017.236">Conway SE, Hwang AY, Ponte CD, Gums JG. Laboratory and clinical monitoring of direct acting oral anticoagulants: What clinicians need to know. <span><span class="ref-journal">Pharmacotherapy. </span>2017;<span class="ref-vol">37</span>:236–48.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/27983747" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27983747</span></a>]<div>
|
||
<i>(Review and recommendations largely on use of coagulation tests to monitor oral anticoagulant therapy, but also concludes: "Hepatic function in otherwise healthy individuals can be assessed yearly or more frequently in those with hepatic impairment").</i>
|
||
</div></div></li><li><div class="bk_ref" id="Edoxaban.REF.alonso.2017.834">Alonso A, MacLehose RF, Chen LY, Bengtson LG, Chamberlain AM, Norby FL, Lutsey PL. Prospective study of oral anticoagulants and risk of liver injury in patients with atrial fibrillation. <span><span class="ref-journal">Heart. </span>2017;<span class="ref-vol">103</span>:834–9.</span> [<a href="/pmc/articles/PMC5429195/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5429195</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/28057799" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28057799</span></a>]<div>
|
||
<i>(Analysis of a database on more than 1 million patients with nonvalvular atrial fibrillation on oral anticoagulants identified 960 hospitalizations with liver injury between 2011 and 2014, rates being highest for warfarin, intermediate for rivaroxaban, and lowest for apixaban and dabigatran; edoxaban was not included in the analyses having been approved for use in 2015).</i>
|
||
</div></div></li><li><div class="bk_ref" id="Edoxaban.REF.nagaoki.2018.51">Nagaoki Y, Aikata H, Daijyo K, Teraoka Y, Shinohara F, Nakamura Y, Hatooka M, et al. Efficacy and safety of edoxaban for treatment of portal vein thrombosis following danaparoid sodium in patients with liver cirrhosis. <span><span class="ref-journal">Hepatol Res. </span>2018;<span class="ref-vol">48</span>:51–8.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/28342265" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28342265</span></a>]<div>
|
||
<i>(Among 50 patients with cirrhosis and portal vein thrombosis treated with low molecular weight heparin followed by either warfarin or edoxaban for up to 6 months, portal vein thrombus reduction was greater with edoxaban and adverse event rates including gastrointestinal bleeding were similar; no mention of ALT elevations and there were no liver related severe adverse events).</i>
|
||
</div></div></li><li><div class="bk_ref" id="Edoxaban.REF.qamar.2019.179">Qamar A, Antman EM, Ruff CT, Nordio F, Murphy SA, Grip LT, Greenberger NJ, et al. Edoxaban versus warfarin in patients with atrial fibrillation and history of liver disease. <span><span class="ref-journal">J Am Coll Cardiol. </span>2019;<span class="ref-vol">74</span>:179–189.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/31296289" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31296289</span></a>]<div>
|
||
<i>(Among 21,105 adults enrolled in a randomized controlled trial of edoxaban [30 or 60 mg daily] versus warfarin, 1083 [5%] had a history of liver disease, and while rates of bleeding episodes were more frequent in those with than without liver disease, rates of stroke, myocardial infarction and suspected drug induced liver injury were similar in the two groups).</i>
|
||
</div></div></li><li><div class="bk_ref" id="Edoxaban.REF.bj_rnsson.2020.1895">Björnsson HK, Gudmundsson DO, Björnsson ES. Liver injury caused by oral anticoagulants: A population-based retrospective cohort study. <span><span class="ref-journal">Liver Int. </span>2020;<span class="ref-vol">40</span>:1895–1900.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/32511827" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 32511827</span></a>]<div>
|
||
<i>(Search of Icelandic National Prescription Databases and Health Records identified 3 cases of clinically apparent, acute liver injury in 3446 [0.1%] patients taking rivaroxaban, but in none of 9101 taking warfarin, or in 1903 taking apixaban, 1335 dabigatran or 34 edoxaban).</i>
|
||
</div></div></li><li><div class="bk_ref" id="Edoxaban.REF.yang.2020.1671">Yang X, Li N, Guo T, Guan X, Tan J, Gao X, Wu Y, Jia L, et al. Comparison of the effects of low-molecular-weight heparin and fondaparinux on liver function in patients with pulmonary embolism. <span><span class="ref-journal">J Clin Pharmacol. </span>2020;<span class="ref-vol">60</span>:1671–1678.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/32639644" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 32639644</span></a>]<div>
|
||
<i>(Among 463 adults with pulmonary embolus treated with low molecular weight heparins or with fondaparinux, 79 [17%] developed evidence of liver injury that was generally mild and less than 3 times ULN in 98%, compared to 15% of 377 on edoxaban, 32% of 59 on nadroparin, and 7.4% of 27 on fondaparinux).</i>
|
||
</div></div></li><li><div class="bk_ref" id="Edoxaban.REF.zhao.2020.1513">Zhao J, Blais JE, Chui CSL, Suh IH, Chen EYH, Seto WK, Mok MT, et al. Association between nonvitamin K antagonist oral anticoagulants or warfarin and liver injury: a cohort study. <span><span class="ref-journal">Am J Gastroenterol. </span>2020;<span class="ref-vol">115</span>:1513–1524.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/32467502" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 32467502</span></a>]<div>
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||
<i>(Among 13,698 patients with atrial fibrillation started on anticoagulant therapy and followed in the Hong Kong Clinical Database and Reporting system between 2010 and 2016, 513 [2.8%] developed evidence of liver injury and propensity matching indicated that liver injury was less frequent [2.1% vs 3.4%], although more severe with oral anticoagulants than with warfarin).</i>
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||
</div></div></li><li><div class="bk_ref" id="Edoxaban.REF.maura.2020.11624">Maura G, Bardou M, Billionnet C, Weill A, Drouin J, Neumann A. Oral anticoagulants and risk of liver injury in patients with nonvalvular atrial fibrillation: a propensity-weighted nationwide cohort study. <span><span class="ref-journal">Sci Rep. </span>2020;<span class="ref-vol">10</span>:11624.</span> [<a href="/pmc/articles/PMC7363898/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC7363898</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/32669591" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 32669591</span></a>]<div>
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||
<i>(Among 434,015 patients with atrial fibrillation started on anticoagulant therapy and followed in the French National Healthcare Database, 218 [0.6%] were subsequently hospitalized for acute liver injury, the rates being similar for those on dabigatran [26 of 51,737 patients], apixaban [29 of 62,503 patients] and rivaroxaban [46 of 99,408 patients]).</i>
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</div></div></li><li><div class="bk_ref" id="Edoxaban.REF.zhou.2021.886">Zhou J, Leung KSK, Kong D, Lee S, Liu T, Wai AKC, Chang C, et al. Low rates of liver injury in edoxaban users: Evidence from a territory-wide observational cohort study. <span><span class="ref-journal">Clin Cardiol. </span>2021;<span class="ref-vol">44</span>:886–889.</span> [<a href="/pmc/articles/PMC8259145/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC8259145</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/33590891" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 33590891</span></a>]<div>
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||
<i>(Among 1213 patients with atrial fibrillation started on edoxaban between 2016 and 2020 and followed in the Hong Kong Clinical Database and Reporting System, 19 [1.5%] developed evidence of liver injury, a rate below that previously reported for warfarin [3.7%], apixaban [2.5%], and rivaroxaban [2.1%]).</i>
|
||
</div></div></li><li><div class="bk_ref" id="Edoxaban.REF.de_caterina.2021.573">De Caterina R, Kim YH, Koretsune Y, Wang CC, Yamashita T, Chen C, Reimitz PE, et al. Safety and effectiveness of edoxaban in atrial fibrillation patients in routine clinical practice: one-year follow-up from the Global Noninterventional ETNA-AF Program. <span><span class="ref-journal">J Clin Med. </span>2021;<span class="ref-vol">10</span>:573.</span> [<a href="/pmc/articles/PMC7913627/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC7913627</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/33546442" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 33546442</span></a>]<div>
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||
<i>(Among 26,823 adults from Europe and Asia with atrial fibrillation enrolled in a postmarketing study of edoxaban, major complications were uncommon including annualized event rates of major bleeding episodes of 1.1%, strokes of 1.1%, cardiovascular mortality in 1.2% and all-cause mortality in 3%; rates of liver injury were not provided).</i>
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||
</div></div></li><li><div class="bk_ref" id="Edoxaban.REF.ma.2023.52">Ma J, Chalasani NP, Schwantes-An L, Björnsson ES. Review article: the safety of anticoagulants and antiplatelet agents in patients with cirrhosis. <span><span class="ref-journal">Aliment Pharmacol Ther. </span>2023;<span class="ref-vol">57</span>:52–71.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/36373544" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 36373544</span></a>]<div>
|
||
<i>(Review of the safety of anticoagulant use in patients with cirrhosis mentions that drug induced liver injury is uncommon in patients with preexisting cirrhosis, at least in those with compensated [Child’s Class A] or mildly compensated [Child’s Class B] cirrhosis).</i>
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<div xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Views</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="PDF_download" id="Shutter"></a></div><div class="portlet_content"><ul xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="simple-list"><li><a href="/books/NBK548805/?report=reader">PubReader</a></li><li><a href="/books/NBK548805/?report=printable">Print View</a></li><li><a data-jig="ncbidialog" href="#_ncbi_dlg_citbx_NBK548805" data-jigconfig="width:400,modal:true">Cite this Page</a><div id="_ncbi_dlg_citbx_NBK548805" style="display:none" title="Cite this Page"><div class="bk_tt">LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. 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<a href="https://www.ncbi.nlm.nih.gov/sites/entrez?cmd=search&db=pubmed&pubmedfilters=true&term=Edoxaban+AND+Human%5BMH%5D+AND+(drug+induced+liver+injury+OR+jaundice/CI+OR+bile+duct+diseases/CI+OR+liver/DE+OR+liver+diseases/CI)+AND+(%221900/1/1%22%5BEDat%5D:%222999/12/31%22%5BEDat%5D)" ref="pagearea=document-links&targetsite=external&targetcat=link&targettype=uri">Recent References on Edoxaban: from PubMed.gov</a>
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<a href="https://clinicaltrials.gov/ct2/results?term=Edoxaban" ref="pagearea=document-links&targetsite=external&targetcat=link&targettype=uri">Trials on Edoxaban: from ClinicalTrials.gov</a>
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Epub 2015 Apr 8.</em></div></div></li><li class="brieflinkpopper two_line"><a class="brieflinkpopperctrl" href="/pubmed/31643347" ref="ordinalpos=1&linkpos=3&log$=relatedreviews&logdbfrom=pubmed"><span xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="invert">Review</span> Rivaroxaban.</a><span class="source">[LiverTox: Clinical and Researc...]</span><div class="brieflinkpop offscreen_noflow"><span xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="invert">Review</span> Rivaroxaban.<div class="brieflinkpopdesc"><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="author">. </em><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="cit">LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. 2012</em></div></div></li><li class="brieflinkpopper two_line"><a class="brieflinkpopperctrl" href="/pubmed/31643763" ref="ordinalpos=1&linkpos=4&log$=relatedreviews&logdbfrom=pubmed"><span xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="invert">Review</span> Betrixaban.</a><span class="source">[LiverTox: Clinical and Researc...]</span><div class="brieflinkpop offscreen_noflow"><span xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="invert">Review</span> Betrixaban.<div class="brieflinkpopdesc"><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="author">. </em><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="cit">LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. 2012</em></div></div></li><li class="brieflinkpopper two_line"><a class="brieflinkpopperctrl" href="/pubmed/27217759" ref="ordinalpos=1&linkpos=5&log$=relatedreviews&logdbfrom=pubmed"><span xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="invert">Review</span> Comparative risk impact of edoxaban in the management of stroke and venous thromboembolism.</a><span class="source">[Ther Clin Risk Manag. 2016]</span><div class="brieflinkpop offscreen_noflow"><span xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="invert">Review</span> Comparative risk impact of edoxaban in the management of stroke and venous thromboembolism.<div class="brieflinkpopdesc"><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="author">Tellor KB, Van Tuyl JS, Armbruster AL. </em><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="cit">Ther Clin Risk Manag. 2016; 12:667-74. 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