Factors related to inappropriate edoxaban use
What is known and objective The aim of this study was to evaluate the appropriateness and clinical outcomes of edoxaban use, and to determine the role of clinical pharmacists in improving the efficacy and safety of edoxaban use. Methods A retrospective study was performed by using an electronic medi...
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| Veröffentlicht in: | Journal of clinical pharmacy and therapeutics 2019-10, Vol.44 (5), p.760-767 |
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| creator | Jang, Bo Min Lee, Ok Sang Shin, Eun Jeong Cho, Eun Jeong Suh, Sung Yeon Cho, Yoon Sook Koo Lee, Myung Rhie, Sandy Jeong |
| description | What is known and objective
The aim of this study was to evaluate the appropriateness and clinical outcomes of edoxaban use, and to determine the role of clinical pharmacists in improving the efficacy and safety of edoxaban use.
Methods
A retrospective study was performed by using an electronic medical record and anticoagulation clinical data from 600 patients who received edoxaban from 1 March 2016 to 16 July 2017 at a tertiary teaching university hospital. The appropriateness of edoxaban use was assessed using eight criteria based on drug use evaluation criteria developed by the American Society of Health‐System Pharmacists drug use evaluation guidelines, details in Korea Food and Drug Administration approval of edoxaban. Clinical outcomes were evaluated between the appropriately prescribed and inappropriately prescribed groups regarding the incidence of thrombosis and bleeding episodes.
Results and discussion
After excluding 86 patients due to the inability to assess renal function, 514 were eligible. Appropriate use was found in 294 patients (57.2%). The most frequent inappropriate use of edoxaban was dose adjustment (60.8%) in accordance with the dosing recommendation in patients with renal insufficiency (creatinine clearance [CrCl] of 15‐50 mL/min) and a low body weight of 95 mL/min in whom edoxaban use is not recommended. Furthermore, we found that the factors related to the appropriateness of edoxaban use were |
| doi_str_mv | 10.1111/jcpt.12999 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2256104286</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2256104286</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3939-eccee8ab04021deb8a099b5f39de859b8ae47d7c7c81a14bdbe41dcad93a85783</originalsourceid><addsrcrecordid>eNp90E1LwzAYB_AgipvTix9ACl5E6Mxbm-Qow_nCQA_zHNLkGXR0bU1a3L69mZ0ePJhLSPjx53n-CF0SPCXx3K1t200JVUodoTFheZZSQfAxGmOaq5QLKkboLIQ1xjgXlJ2iEYuaKiHHKJ0b2zU-JB4q04FLuiYpa9O2vml9GX8ScM3WFKZO-gDn6GRlqgAXh3uC3ucPy9lTunh9fJ7dL1LLFFMpWAsgTYE5psRBIQ1WqshWTDmQmYpv4MIJK6wkhvDCFcCJs8YpZmQmJJugmyE3jvHRQ-j0pgwWqsrU0PRBU5rlBHMq80iv_9B10_s6TheV5ExyIVRUt4OyvgnBw0rH7TbG7zTBel-i3peov0uM-OoQ2RcbcL_0p7UIyAA-ywp2_0Tpl9nbcgj9AqAHfAA</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2284384779</pqid></control><display><type>article</type><title>Factors related to inappropriate edoxaban use</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><creator>Jang, Bo Min ; Lee, Ok Sang ; Shin, Eun Jeong ; Cho, Eun Jeong ; Suh, Sung Yeon ; Cho, Yoon Sook ; Koo Lee, Myung ; Rhie, Sandy Jeong</creator><creatorcontrib>Jang, Bo Min ; Lee, Ok Sang ; Shin, Eun Jeong ; Cho, Eun Jeong ; Suh, Sung Yeon ; Cho, Yoon Sook ; Koo Lee, Myung ; Rhie, Sandy Jeong</creatorcontrib><description>What is known and objective
The aim of this study was to evaluate the appropriateness and clinical outcomes of edoxaban use, and to determine the role of clinical pharmacists in improving the efficacy and safety of edoxaban use.
Methods
A retrospective study was performed by using an electronic medical record and anticoagulation clinical data from 600 patients who received edoxaban from 1 March 2016 to 16 July 2017 at a tertiary teaching university hospital. The appropriateness of edoxaban use was assessed using eight criteria based on drug use evaluation criteria developed by the American Society of Health‐System Pharmacists drug use evaluation guidelines, details in Korea Food and Drug Administration approval of edoxaban. Clinical outcomes were evaluated between the appropriately prescribed and inappropriately prescribed groups regarding the incidence of thrombosis and bleeding episodes.
Results and discussion
After excluding 86 patients due to the inability to assess renal function, 514 were eligible. Appropriate use was found in 294 patients (57.2%). The most frequent inappropriate use of edoxaban was dose adjustment (60.8%) in accordance with the dosing recommendation in patients with renal insufficiency (creatinine clearance [CrCl] of 15‐50 mL/min) and a low body weight of <60 kg. Moreover, there were three cases of edoxaban use in patients with prosthetic heart valves and moderate‐to‐severe mitral stenosis, and 15 cases of non‐valvular atrial fibrillation in patients with CrCl >95 mL/min in whom edoxaban use is not recommended. Furthermore, we found that the factors related to the appropriateness of edoxaban use were <60 kg body weight (adjusted odds ratio [OR]: 0.310; confidence interval [CI]: 0.197‐0.488) and CrCl <50 mL/min (adjusted OR: 0.629; CI: 0.404‐0.980). There were 45 events (8.75%) of any bleeding, 9 (1.8%) of stroke/transient ischaemic attack (TIA) and four events (0.8%) of deep vein thrombosis (DVT)/pulmonary embolism (PE). However, there was no difference between the appropriately prescribed group (294 patients) and inappropriately prescribed group (220 patients) in the incidence of bleeding events (27 [9.2%] vs 18 [8.2%]), stroke/TIA (7 [2.4%] vs 2 [0.9%]) and DVT/PE (2 [0.7%] vs 2 [0.9%]), respectively.
What is new and conclusion
Although edoxaban has a broad therapeutic window that does not require routine monitoring, it should be cautiously used in patients with renal insufficiency (CrCl <50 mL/min) and body weight <60 kg.</description><identifier>ISSN: 0269-4727</identifier><identifier>EISSN: 1365-2710</identifier><identifier>DOI: 10.1111/jcpt.12999</identifier><identifier>PMID: 31292978</identifier><language>eng</language><publisher>England: Hindawi Limited</publisher><subject>Aged ; Anticoagulants ; Anticoagulants - adverse effects ; Atrial Fibrillation - drug therapy ; Bleeding ; Blood Coagulation - drug effects ; Body weight ; clinical outcome ; Clinical outcomes ; Creatinine ; Dosage ; dose adjustment ; Drug use ; drug use evaluation ; edoxaban ; Electronic medical records ; Embolism ; Evaluation ; Factor Xa Inhibitors - adverse effects ; Female ; Fibrillation ; Hemorrhage - chemically induced ; Humans ; Incidence ; Male ; Patients ; Pharmacists ; Prosthetic valves ; Pyridines - adverse effects ; Renal function ; Renal insufficiency ; Renal Insufficiency - chemically induced ; Republic of Korea ; Retrospective Studies ; Stenosis ; Stroke ; Stroke - chemically induced ; Thiazoles - adverse effects ; Thromboembolism ; Thrombosis ; Transient ischemic attack</subject><ispartof>Journal of clinical pharmacy and therapeutics, 2019-10, Vol.44 (5), p.760-767</ispartof><rights>2019 John Wiley & Sons Ltd</rights><rights>2019 John Wiley & Sons Ltd.</rights><rights>Copyright © 2019 John Wiley & Sons Ltd</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3939-eccee8ab04021deb8a099b5f39de859b8ae47d7c7c81a14bdbe41dcad93a85783</citedby><cites>FETCH-LOGICAL-c3939-eccee8ab04021deb8a099b5f39de859b8ae47d7c7c81a14bdbe41dcad93a85783</cites><orcidid>0000-0003-2554-3370</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fjcpt.12999$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fjcpt.12999$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,777,781,1413,27906,27907,45556,45557</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31292978$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Jang, Bo Min</creatorcontrib><creatorcontrib>Lee, Ok Sang</creatorcontrib><creatorcontrib>Shin, Eun Jeong</creatorcontrib><creatorcontrib>Cho, Eun Jeong</creatorcontrib><creatorcontrib>Suh, Sung Yeon</creatorcontrib><creatorcontrib>Cho, Yoon Sook</creatorcontrib><creatorcontrib>Koo Lee, Myung</creatorcontrib><creatorcontrib>Rhie, Sandy Jeong</creatorcontrib><title>Factors related to inappropriate edoxaban use</title><title>Journal of clinical pharmacy and therapeutics</title><addtitle>J Clin Pharm Ther</addtitle><description>What is known and objective
The aim of this study was to evaluate the appropriateness and clinical outcomes of edoxaban use, and to determine the role of clinical pharmacists in improving the efficacy and safety of edoxaban use.
Methods
A retrospective study was performed by using an electronic medical record and anticoagulation clinical data from 600 patients who received edoxaban from 1 March 2016 to 16 July 2017 at a tertiary teaching university hospital. The appropriateness of edoxaban use was assessed using eight criteria based on drug use evaluation criteria developed by the American Society of Health‐System Pharmacists drug use evaluation guidelines, details in Korea Food and Drug Administration approval of edoxaban. Clinical outcomes were evaluated between the appropriately prescribed and inappropriately prescribed groups regarding the incidence of thrombosis and bleeding episodes.
Results and discussion
After excluding 86 patients due to the inability to assess renal function, 514 were eligible. Appropriate use was found in 294 patients (57.2%). The most frequent inappropriate use of edoxaban was dose adjustment (60.8%) in accordance with the dosing recommendation in patients with renal insufficiency (creatinine clearance [CrCl] of 15‐50 mL/min) and a low body weight of <60 kg. Moreover, there were three cases of edoxaban use in patients with prosthetic heart valves and moderate‐to‐severe mitral stenosis, and 15 cases of non‐valvular atrial fibrillation in patients with CrCl >95 mL/min in whom edoxaban use is not recommended. Furthermore, we found that the factors related to the appropriateness of edoxaban use were <60 kg body weight (adjusted odds ratio [OR]: 0.310; confidence interval [CI]: 0.197‐0.488) and CrCl <50 mL/min (adjusted OR: 0.629; CI: 0.404‐0.980). There were 45 events (8.75%) of any bleeding, 9 (1.8%) of stroke/transient ischaemic attack (TIA) and four events (0.8%) of deep vein thrombosis (DVT)/pulmonary embolism (PE). However, there was no difference between the appropriately prescribed group (294 patients) and inappropriately prescribed group (220 patients) in the incidence of bleeding events (27 [9.2%] vs 18 [8.2%]), stroke/TIA (7 [2.4%] vs 2 [0.9%]) and DVT/PE (2 [0.7%] vs 2 [0.9%]), respectively.
What is new and conclusion
Although edoxaban has a broad therapeutic window that does not require routine monitoring, it should be cautiously used in patients with renal insufficiency (CrCl <50 mL/min) and body weight <60 kg.</description><subject>Aged</subject><subject>Anticoagulants</subject><subject>Anticoagulants - adverse effects</subject><subject>Atrial Fibrillation - drug therapy</subject><subject>Bleeding</subject><subject>Blood Coagulation - drug effects</subject><subject>Body weight</subject><subject>clinical outcome</subject><subject>Clinical outcomes</subject><subject>Creatinine</subject><subject>Dosage</subject><subject>dose adjustment</subject><subject>Drug use</subject><subject>drug use evaluation</subject><subject>edoxaban</subject><subject>Electronic medical records</subject><subject>Embolism</subject><subject>Evaluation</subject><subject>Factor Xa Inhibitors - adverse effects</subject><subject>Female</subject><subject>Fibrillation</subject><subject>Hemorrhage - chemically induced</subject><subject>Humans</subject><subject>Incidence</subject><subject>Male</subject><subject>Patients</subject><subject>Pharmacists</subject><subject>Prosthetic valves</subject><subject>Pyridines - adverse effects</subject><subject>Renal function</subject><subject>Renal insufficiency</subject><subject>Renal Insufficiency - chemically induced</subject><subject>Republic of Korea</subject><subject>Retrospective Studies</subject><subject>Stenosis</subject><subject>Stroke</subject><subject>Stroke - chemically induced</subject><subject>Thiazoles - adverse effects</subject><subject>Thromboembolism</subject><subject>Thrombosis</subject><subject>Transient ischemic attack</subject><issn>0269-4727</issn><issn>1365-2710</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp90E1LwzAYB_AgipvTix9ACl5E6Mxbm-Qow_nCQA_zHNLkGXR0bU1a3L69mZ0ePJhLSPjx53n-CF0SPCXx3K1t200JVUodoTFheZZSQfAxGmOaq5QLKkboLIQ1xjgXlJ2iEYuaKiHHKJ0b2zU-JB4q04FLuiYpa9O2vml9GX8ScM3WFKZO-gDn6GRlqgAXh3uC3ucPy9lTunh9fJ7dL1LLFFMpWAsgTYE5psRBIQ1WqshWTDmQmYpv4MIJK6wkhvDCFcCJs8YpZmQmJJugmyE3jvHRQ-j0pgwWqsrU0PRBU5rlBHMq80iv_9B10_s6TheV5ExyIVRUt4OyvgnBw0rH7TbG7zTBel-i3peov0uM-OoQ2RcbcL_0p7UIyAA-ywp2_0Tpl9nbcgj9AqAHfAA</recordid><startdate>201910</startdate><enddate>201910</enddate><creator>Jang, Bo Min</creator><creator>Lee, Ok Sang</creator><creator>Shin, Eun Jeong</creator><creator>Cho, Eun Jeong</creator><creator>Suh, Sung Yeon</creator><creator>Cho, Yoon Sook</creator><creator>Koo Lee, Myung</creator><creator>Rhie, Sandy Jeong</creator><general>Hindawi Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7TM</scope><scope>7TO</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-2554-3370</orcidid></search><sort><creationdate>201910</creationdate><title>Factors related to inappropriate edoxaban use</title><author>Jang, Bo Min ; Lee, Ok Sang ; Shin, Eun Jeong ; Cho, Eun Jeong ; Suh, Sung Yeon ; Cho, Yoon Sook ; Koo Lee, Myung ; Rhie, Sandy Jeong</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3939-eccee8ab04021deb8a099b5f39de859b8ae47d7c7c81a14bdbe41dcad93a85783</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Aged</topic><topic>Anticoagulants</topic><topic>Anticoagulants - adverse effects</topic><topic>Atrial Fibrillation - drug therapy</topic><topic>Bleeding</topic><topic>Blood Coagulation - drug effects</topic><topic>Body weight</topic><topic>clinical outcome</topic><topic>Clinical outcomes</topic><topic>Creatinine</topic><topic>Dosage</topic><topic>dose adjustment</topic><topic>Drug use</topic><topic>drug use evaluation</topic><topic>edoxaban</topic><topic>Electronic medical records</topic><topic>Embolism</topic><topic>Evaluation</topic><topic>Factor Xa Inhibitors - adverse effects</topic><topic>Female</topic><topic>Fibrillation</topic><topic>Hemorrhage - chemically induced</topic><topic>Humans</topic><topic>Incidence</topic><topic>Male</topic><topic>Patients</topic><topic>Pharmacists</topic><topic>Prosthetic valves</topic><topic>Pyridines - adverse effects</topic><topic>Renal function</topic><topic>Renal insufficiency</topic><topic>Renal Insufficiency - chemically induced</topic><topic>Republic of Korea</topic><topic>Retrospective Studies</topic><topic>Stenosis</topic><topic>Stroke</topic><topic>Stroke - chemically induced</topic><topic>Thiazoles - adverse effects</topic><topic>Thromboembolism</topic><topic>Thrombosis</topic><topic>Transient ischemic attack</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Jang, Bo Min</creatorcontrib><creatorcontrib>Lee, Ok Sang</creatorcontrib><creatorcontrib>Shin, Eun Jeong</creatorcontrib><creatorcontrib>Cho, Eun Jeong</creatorcontrib><creatorcontrib>Suh, Sung Yeon</creatorcontrib><creatorcontrib>Cho, Yoon Sook</creatorcontrib><creatorcontrib>Koo Lee, Myung</creatorcontrib><creatorcontrib>Rhie, Sandy Jeong</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of clinical pharmacy and therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jang, Bo Min</au><au>Lee, Ok Sang</au><au>Shin, Eun Jeong</au><au>Cho, Eun Jeong</au><au>Suh, Sung Yeon</au><au>Cho, Yoon Sook</au><au>Koo Lee, Myung</au><au>Rhie, Sandy Jeong</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Factors related to inappropriate edoxaban use</atitle><jtitle>Journal of clinical pharmacy and therapeutics</jtitle><addtitle>J Clin Pharm Ther</addtitle><date>2019-10</date><risdate>2019</risdate><volume>44</volume><issue>5</issue><spage>760</spage><epage>767</epage><pages>760-767</pages><issn>0269-4727</issn><eissn>1365-2710</eissn><abstract>What is known and objective
The aim of this study was to evaluate the appropriateness and clinical outcomes of edoxaban use, and to determine the role of clinical pharmacists in improving the efficacy and safety of edoxaban use.
Methods
A retrospective study was performed by using an electronic medical record and anticoagulation clinical data from 600 patients who received edoxaban from 1 March 2016 to 16 July 2017 at a tertiary teaching university hospital. The appropriateness of edoxaban use was assessed using eight criteria based on drug use evaluation criteria developed by the American Society of Health‐System Pharmacists drug use evaluation guidelines, details in Korea Food and Drug Administration approval of edoxaban. Clinical outcomes were evaluated between the appropriately prescribed and inappropriately prescribed groups regarding the incidence of thrombosis and bleeding episodes.
Results and discussion
After excluding 86 patients due to the inability to assess renal function, 514 were eligible. Appropriate use was found in 294 patients (57.2%). The most frequent inappropriate use of edoxaban was dose adjustment (60.8%) in accordance with the dosing recommendation in patients with renal insufficiency (creatinine clearance [CrCl] of 15‐50 mL/min) and a low body weight of <60 kg. Moreover, there were three cases of edoxaban use in patients with prosthetic heart valves and moderate‐to‐severe mitral stenosis, and 15 cases of non‐valvular atrial fibrillation in patients with CrCl >95 mL/min in whom edoxaban use is not recommended. Furthermore, we found that the factors related to the appropriateness of edoxaban use were <60 kg body weight (adjusted odds ratio [OR]: 0.310; confidence interval [CI]: 0.197‐0.488) and CrCl <50 mL/min (adjusted OR: 0.629; CI: 0.404‐0.980). There were 45 events (8.75%) of any bleeding, 9 (1.8%) of stroke/transient ischaemic attack (TIA) and four events (0.8%) of deep vein thrombosis (DVT)/pulmonary embolism (PE). However, there was no difference between the appropriately prescribed group (294 patients) and inappropriately prescribed group (220 patients) in the incidence of bleeding events (27 [9.2%] vs 18 [8.2%]), stroke/TIA (7 [2.4%] vs 2 [0.9%]) and DVT/PE (2 [0.7%] vs 2 [0.9%]), respectively.
What is new and conclusion
Although edoxaban has a broad therapeutic window that does not require routine monitoring, it should be cautiously used in patients with renal insufficiency (CrCl <50 mL/min) and body weight <60 kg.</abstract><cop>England</cop><pub>Hindawi Limited</pub><pmid>31292978</pmid><doi>10.1111/jcpt.12999</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0003-2554-3370</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of clinical pharmacy and therapeutics, 2019-10, Vol.44 (5), p.760-767 |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Aged Anticoagulants Anticoagulants - adverse effects Atrial Fibrillation - drug therapy Bleeding Blood Coagulation - drug effects Body weight clinical outcome Clinical outcomes Creatinine Dosage dose adjustment Drug use drug use evaluation edoxaban Electronic medical records Embolism Evaluation Factor Xa Inhibitors - adverse effects Female Fibrillation Hemorrhage - chemically induced Humans Incidence Male Patients Pharmacists Prosthetic valves Pyridines - adverse effects Renal function Renal insufficiency Renal Insufficiency - chemically induced Republic of Korea Retrospective Studies Stenosis Stroke Stroke - chemically induced Thiazoles - adverse effects Thromboembolism Thrombosis Transient ischemic attack |
| title | Factors related to inappropriate edoxaban use |
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