Optimal dose of dabigatran for the prevention of thromboembolism with minimal bleeding risk in Korean patients with atrial fibrillation
We aim to determine the optimal dose of dabigatran in Korean patients with atrial fibrillation (AF). We analysed 1834 patients with non-valvular AF, classified into a warfarin group (n = 990), dabigatran 150 mg group (D150, n = 294), and 110 mg group (D110, n = 550). The D110 group was further class...
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| Veröffentlicht in: | Europace (London, England) England), 2017-12, Vol.19 (suppl_4), p.iv1-iv9 |
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| creator | Lee, Ki Hong Park, Hyung Wook Lee, Nuri Hyun, Dae Young Won, Jumin Oh, Sung Sik Park, Hyuk Jin Kim, Yongcheol Cho, Jae Yeong Kim, Min Chul Sim, Doo Sun Yoon, Hyun Joo Yoon, Nam Sik Kim, Kye Hun Hong, Young Joon Kim, Ju Han Ahn, Youngkeun Jeong, Myung Ho Park, Jong Chun Cho, Jeong Gwan |
| description | We aim to determine the optimal dose of dabigatran in Korean patients with atrial fibrillation (AF).
We analysed 1834 patients with non-valvular AF, classified into a warfarin group (n = 990), dabigatran 150 mg group (D150, n = 294), and 110 mg group (D110, n = 550). The D110 group was further classified into patients concordant (co-D110, n = 367) and patients discordant (di-D110, n = 183) with guidelines to dose reduction. Propensity-matched 1-year clinical outcomes were then compared. Efficacy outcomes were defined as thromboembolism composed of new-onset stroke or systemic embolism. Safety outcomes were major bleeding. Both D150 and D110 had comparable efficacies as warfarin. However, only D110 significantly lowered the risk of major bleeding [hazard ratio (HR) 0.19, 95% confidence interval (CI) 0.07-0.55, P = 0.002]. In a subgroup analysis according to guideline-concordant indications for dose reduction, both co-D110 and di-D110 displayed a comparable efficacy as warfarin. Both co-D110 (HR 0.22, 95% CI 0.06-0.76, P = 0.017) and di-D110 (HR 0.11, 95% CI 0.02-0.81, P = 0.030) significantly lowered incidences of major bleeding. There were no differences in the efficacy and safety between di-D110 and D150, and net clinical outcomes were similar.
Although D150 and D110 had a comparable efficacy, only D110 lowered the risk of major bleeding in Korean AF patients compared with warfarin. Even the guideline-discordant use of dabigatran 110 mg demonstrated a similar efficacy and safety compared with D150. However, further prospective randomized trials are needed in order to comprehensively evaluate whether D150 or D110 is the optimal dosage in Asian patients with AF. |
| doi_str_mv | 10.1093/europace/eux247 |
| format | Article |
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We analysed 1834 patients with non-valvular AF, classified into a warfarin group (n = 990), dabigatran 150 mg group (D150, n = 294), and 110 mg group (D110, n = 550). The D110 group was further classified into patients concordant (co-D110, n = 367) and patients discordant (di-D110, n = 183) with guidelines to dose reduction. Propensity-matched 1-year clinical outcomes were then compared. Efficacy outcomes were defined as thromboembolism composed of new-onset stroke or systemic embolism. Safety outcomes were major bleeding. Both D150 and D110 had comparable efficacies as warfarin. However, only D110 significantly lowered the risk of major bleeding [hazard ratio (HR) 0.19, 95% confidence interval (CI) 0.07-0.55, P = 0.002]. In a subgroup analysis according to guideline-concordant indications for dose reduction, both co-D110 and di-D110 displayed a comparable efficacy as warfarin. Both co-D110 (HR 0.22, 95% CI 0.06-0.76, P = 0.017) and di-D110 (HR 0.11, 95% CI 0.02-0.81, P = 0.030) significantly lowered incidences of major bleeding. There were no differences in the efficacy and safety between di-D110 and D150, and net clinical outcomes were similar.
Although D150 and D110 had a comparable efficacy, only D110 lowered the risk of major bleeding in Korean AF patients compared with warfarin. Even the guideline-discordant use of dabigatran 110 mg demonstrated a similar efficacy and safety compared with D150. However, further prospective randomized trials are needed in order to comprehensively evaluate whether D150 or D110 is the optimal dosage in Asian patients with AF.</description><identifier>ISSN: 1099-5129</identifier><identifier>EISSN: 1532-2092</identifier><identifier>DOI: 10.1093/europace/eux247</identifier><identifier>PMID: 29220421</identifier><language>eng</language><publisher>England</publisher><subject><![CDATA[Aged ; Aged, 80 and over ; Anticoagulants - administration & dosage ; Anticoagulants - adverse effects ; Antithrombins - administration & dosage ; Antithrombins - adverse effects ; Atrial Fibrillation - blood ; Atrial Fibrillation - complications ; Atrial Fibrillation - diagnosis ; Atrial Fibrillation - drug therapy ; Blood Coagulation - drug effects ; Chi-Square Distribution ; Dabigatran - administration & dosage ; Dabigatran - adverse effects ; Female ; Hemorrhage - chemically induced ; Hemorrhage - prevention & control ; Humans ; Kaplan-Meier Estimate ; Logistic Models ; Male ; Middle Aged ; Propensity Score ; Proportional Hazards Models ; Republic of Korea ; Retrospective Studies ; Risk Assessment ; Risk Factors ; Stroke - blood ; Stroke - diagnosis ; Stroke - etiology ; Stroke - prevention & control ; Thromboembolism - blood ; Thromboembolism - diagnosis ; Thromboembolism - etiology ; Thromboembolism - prevention & control ; Time Factors ; Treatment Outcome ; Warfarin - administration & dosage ; Warfarin - adverse effects]]></subject><ispartof>Europace (London, England), 2017-12, Vol.19 (suppl_4), p.iv1-iv9</ispartof><rights>Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For Permissions, please email: journals.permissions@oup.com.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c338t-c5b2d134e32daeb424fedbc37145a4c804410f33dd496bfc3a79d05029c576063</citedby><cites>FETCH-LOGICAL-c338t-c5b2d134e32daeb424fedbc37145a4c804410f33dd496bfc3a79d05029c576063</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29220421$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lee, Ki Hong</creatorcontrib><creatorcontrib>Park, Hyung Wook</creatorcontrib><creatorcontrib>Lee, Nuri</creatorcontrib><creatorcontrib>Hyun, Dae Young</creatorcontrib><creatorcontrib>Won, Jumin</creatorcontrib><creatorcontrib>Oh, Sung Sik</creatorcontrib><creatorcontrib>Park, Hyuk Jin</creatorcontrib><creatorcontrib>Kim, Yongcheol</creatorcontrib><creatorcontrib>Cho, Jae Yeong</creatorcontrib><creatorcontrib>Kim, Min Chul</creatorcontrib><creatorcontrib>Sim, Doo Sun</creatorcontrib><creatorcontrib>Yoon, Hyun Joo</creatorcontrib><creatorcontrib>Yoon, Nam Sik</creatorcontrib><creatorcontrib>Kim, Kye Hun</creatorcontrib><creatorcontrib>Hong, Young Joon</creatorcontrib><creatorcontrib>Kim, Ju Han</creatorcontrib><creatorcontrib>Ahn, Youngkeun</creatorcontrib><creatorcontrib>Jeong, Myung Ho</creatorcontrib><creatorcontrib>Park, Jong Chun</creatorcontrib><creatorcontrib>Cho, Jeong Gwan</creatorcontrib><title>Optimal dose of dabigatran for the prevention of thromboembolism with minimal bleeding risk in Korean patients with atrial fibrillation</title><title>Europace (London, England)</title><addtitle>Europace</addtitle><description>We aim to determine the optimal dose of dabigatran in Korean patients with atrial fibrillation (AF).
We analysed 1834 patients with non-valvular AF, classified into a warfarin group (n = 990), dabigatran 150 mg group (D150, n = 294), and 110 mg group (D110, n = 550). The D110 group was further classified into patients concordant (co-D110, n = 367) and patients discordant (di-D110, n = 183) with guidelines to dose reduction. Propensity-matched 1-year clinical outcomes were then compared. Efficacy outcomes were defined as thromboembolism composed of new-onset stroke or systemic embolism. Safety outcomes were major bleeding. Both D150 and D110 had comparable efficacies as warfarin. However, only D110 significantly lowered the risk of major bleeding [hazard ratio (HR) 0.19, 95% confidence interval (CI) 0.07-0.55, P = 0.002]. In a subgroup analysis according to guideline-concordant indications for dose reduction, both co-D110 and di-D110 displayed a comparable efficacy as warfarin. Both co-D110 (HR 0.22, 95% CI 0.06-0.76, P = 0.017) and di-D110 (HR 0.11, 95% CI 0.02-0.81, P = 0.030) significantly lowered incidences of major bleeding. There were no differences in the efficacy and safety between di-D110 and D150, and net clinical outcomes were similar.
Although D150 and D110 had a comparable efficacy, only D110 lowered the risk of major bleeding in Korean AF patients compared with warfarin. Even the guideline-discordant use of dabigatran 110 mg demonstrated a similar efficacy and safety compared with D150. However, further prospective randomized trials are needed in order to comprehensively evaluate whether D150 or D110 is the optimal dosage in Asian patients with AF.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anticoagulants - administration & dosage</subject><subject>Anticoagulants - adverse effects</subject><subject>Antithrombins - administration & dosage</subject><subject>Antithrombins - adverse effects</subject><subject>Atrial Fibrillation - blood</subject><subject>Atrial Fibrillation - complications</subject><subject>Atrial Fibrillation - diagnosis</subject><subject>Atrial Fibrillation - drug therapy</subject><subject>Blood Coagulation - drug effects</subject><subject>Chi-Square Distribution</subject><subject>Dabigatran - administration & dosage</subject><subject>Dabigatran - adverse effects</subject><subject>Female</subject><subject>Hemorrhage - chemically induced</subject><subject>Hemorrhage - prevention & control</subject><subject>Humans</subject><subject>Kaplan-Meier Estimate</subject><subject>Logistic Models</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Propensity Score</subject><subject>Proportional Hazards Models</subject><subject>Republic of Korea</subject><subject>Retrospective Studies</subject><subject>Risk Assessment</subject><subject>Risk Factors</subject><subject>Stroke - blood</subject><subject>Stroke - diagnosis</subject><subject>Stroke - etiology</subject><subject>Stroke - prevention & control</subject><subject>Thromboembolism - blood</subject><subject>Thromboembolism - diagnosis</subject><subject>Thromboembolism - etiology</subject><subject>Thromboembolism - prevention & control</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Warfarin - administration & dosage</subject><subject>Warfarin - adverse effects</subject><issn>1099-5129</issn><issn>1532-2092</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo9kMtOwzAQRS0EoqWwZof8A6F-pamXqOIlKnUD68iPSWtI4sh2eXwBv41LKYvRzOLco9FF6JKSa0okn8I2-EEZyMcnE9URGtOSs4IRyY7zTaQsSsrkCJ3F-EoIqZgsT9GIScaIYHSMvldDcp1qsfURsG-wVdqtVQqqx40POG0ADwHeoU_O9zsgbYLvtIc8rYsd_nBpgzvX_1p0C2Bdv8bBxTfsevzkA2TVoJLLirins95luHE6uLZVO_M5OmlUG-Hib0_Qy93t8-KhWK7uHxc3y8JwPk-FKTWzlAvgzCrQgokGrDa8oqJUwsyJEJQ0nFsr5Ew3hqtKWlISJk1ZzciMT9B07zXBxxigqYeQPw9fNSX1rtL6UGm9rzQnrvaJYas7sP_8oUP-AyDaeOk</recordid><startdate>20171201</startdate><enddate>20171201</enddate><creator>Lee, Ki Hong</creator><creator>Park, Hyung Wook</creator><creator>Lee, Nuri</creator><creator>Hyun, Dae Young</creator><creator>Won, Jumin</creator><creator>Oh, Sung Sik</creator><creator>Park, Hyuk Jin</creator><creator>Kim, Yongcheol</creator><creator>Cho, Jae Yeong</creator><creator>Kim, Min Chul</creator><creator>Sim, Doo Sun</creator><creator>Yoon, Hyun Joo</creator><creator>Yoon, Nam Sik</creator><creator>Kim, Kye Hun</creator><creator>Hong, Young Joon</creator><creator>Kim, Ju Han</creator><creator>Ahn, Youngkeun</creator><creator>Jeong, Myung Ho</creator><creator>Park, Jong Chun</creator><creator>Cho, Jeong Gwan</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>20171201</creationdate><title>Optimal dose of dabigatran for the prevention of thromboembolism with minimal bleeding risk in Korean patients with atrial fibrillation</title><author>Lee, Ki Hong ; Park, Hyung Wook ; Lee, Nuri ; Hyun, Dae Young ; Won, Jumin ; Oh, Sung Sik ; Park, Hyuk Jin ; Kim, Yongcheol ; Cho, Jae Yeong ; Kim, Min Chul ; Sim, Doo Sun ; Yoon, Hyun Joo ; Yoon, Nam Sik ; Kim, Kye Hun ; Hong, Young Joon ; Kim, Ju Han ; Ahn, Youngkeun ; Jeong, Myung Ho ; Park, Jong Chun ; Cho, Jeong Gwan</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c338t-c5b2d134e32daeb424fedbc37145a4c804410f33dd496bfc3a79d05029c576063</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anticoagulants - administration & dosage</topic><topic>Anticoagulants - adverse effects</topic><topic>Antithrombins - administration & dosage</topic><topic>Antithrombins - adverse effects</topic><topic>Atrial Fibrillation - blood</topic><topic>Atrial Fibrillation - complications</topic><topic>Atrial Fibrillation - diagnosis</topic><topic>Atrial Fibrillation - drug therapy</topic><topic>Blood Coagulation - drug effects</topic><topic>Chi-Square Distribution</topic><topic>Dabigatran - administration & dosage</topic><topic>Dabigatran - adverse effects</topic><topic>Female</topic><topic>Hemorrhage - chemically induced</topic><topic>Hemorrhage - prevention & control</topic><topic>Humans</topic><topic>Kaplan-Meier Estimate</topic><topic>Logistic Models</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Propensity Score</topic><topic>Proportional Hazards Models</topic><topic>Republic of Korea</topic><topic>Retrospective Studies</topic><topic>Risk Assessment</topic><topic>Risk Factors</topic><topic>Stroke - blood</topic><topic>Stroke - diagnosis</topic><topic>Stroke - etiology</topic><topic>Stroke - prevention & control</topic><topic>Thromboembolism - blood</topic><topic>Thromboembolism - diagnosis</topic><topic>Thromboembolism - etiology</topic><topic>Thromboembolism - prevention & control</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Warfarin - administration & dosage</topic><topic>Warfarin - adverse effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lee, Ki Hong</creatorcontrib><creatorcontrib>Park, Hyung Wook</creatorcontrib><creatorcontrib>Lee, Nuri</creatorcontrib><creatorcontrib>Hyun, Dae Young</creatorcontrib><creatorcontrib>Won, Jumin</creatorcontrib><creatorcontrib>Oh, Sung Sik</creatorcontrib><creatorcontrib>Park, Hyuk Jin</creatorcontrib><creatorcontrib>Kim, Yongcheol</creatorcontrib><creatorcontrib>Cho, Jae Yeong</creatorcontrib><creatorcontrib>Kim, Min Chul</creatorcontrib><creatorcontrib>Sim, Doo Sun</creatorcontrib><creatorcontrib>Yoon, Hyun Joo</creatorcontrib><creatorcontrib>Yoon, Nam Sik</creatorcontrib><creatorcontrib>Kim, Kye Hun</creatorcontrib><creatorcontrib>Hong, Young Joon</creatorcontrib><creatorcontrib>Kim, Ju Han</creatorcontrib><creatorcontrib>Ahn, Youngkeun</creatorcontrib><creatorcontrib>Jeong, Myung Ho</creatorcontrib><creatorcontrib>Park, Jong Chun</creatorcontrib><creatorcontrib>Cho, Jeong Gwan</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Europace (London, England)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lee, Ki Hong</au><au>Park, Hyung Wook</au><au>Lee, Nuri</au><au>Hyun, Dae Young</au><au>Won, Jumin</au><au>Oh, Sung Sik</au><au>Park, Hyuk Jin</au><au>Kim, Yongcheol</au><au>Cho, Jae Yeong</au><au>Kim, Min Chul</au><au>Sim, Doo Sun</au><au>Yoon, Hyun Joo</au><au>Yoon, Nam Sik</au><au>Kim, Kye Hun</au><au>Hong, Young Joon</au><au>Kim, Ju Han</au><au>Ahn, Youngkeun</au><au>Jeong, Myung Ho</au><au>Park, Jong Chun</au><au>Cho, Jeong Gwan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Optimal dose of dabigatran for the prevention of thromboembolism with minimal bleeding risk in Korean patients with atrial fibrillation</atitle><jtitle>Europace (London, England)</jtitle><addtitle>Europace</addtitle><date>2017-12-01</date><risdate>2017</risdate><volume>19</volume><issue>suppl_4</issue><spage>iv1</spage><epage>iv9</epage><pages>iv1-iv9</pages><issn>1099-5129</issn><eissn>1532-2092</eissn><abstract>We aim to determine the optimal dose of dabigatran in Korean patients with atrial fibrillation (AF).
We analysed 1834 patients with non-valvular AF, classified into a warfarin group (n = 990), dabigatran 150 mg group (D150, n = 294), and 110 mg group (D110, n = 550). The D110 group was further classified into patients concordant (co-D110, n = 367) and patients discordant (di-D110, n = 183) with guidelines to dose reduction. Propensity-matched 1-year clinical outcomes were then compared. Efficacy outcomes were defined as thromboembolism composed of new-onset stroke or systemic embolism. Safety outcomes were major bleeding. Both D150 and D110 had comparable efficacies as warfarin. However, only D110 significantly lowered the risk of major bleeding [hazard ratio (HR) 0.19, 95% confidence interval (CI) 0.07-0.55, P = 0.002]. In a subgroup analysis according to guideline-concordant indications for dose reduction, both co-D110 and di-D110 displayed a comparable efficacy as warfarin. Both co-D110 (HR 0.22, 95% CI 0.06-0.76, P = 0.017) and di-D110 (HR 0.11, 95% CI 0.02-0.81, P = 0.030) significantly lowered incidences of major bleeding. There were no differences in the efficacy and safety between di-D110 and D150, and net clinical outcomes were similar.
Although D150 and D110 had a comparable efficacy, only D110 lowered the risk of major bleeding in Korean AF patients compared with warfarin. Even the guideline-discordant use of dabigatran 110 mg demonstrated a similar efficacy and safety compared with D150. However, further prospective randomized trials are needed in order to comprehensively evaluate whether D150 or D110 is the optimal dosage in Asian patients with AF.</abstract><cop>England</cop><pmid>29220421</pmid><doi>10.1093/europace/eux247</doi><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 1099-5129 |
| ispartof | Europace (London, England), 2017-12, Vol.19 (suppl_4), p.iv1-iv9 |
| issn | 1099-5129 1532-2092 |
| language | eng |
| recordid | cdi_crossref_primary_10_1093_europace_eux247 |
| source | MEDLINE; Access via Oxford University Press (Open Access Collection); Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; Alma/SFX Local Collection |
| subjects | Aged Aged, 80 and over Anticoagulants - administration & dosage Anticoagulants - adverse effects Antithrombins - administration & dosage Antithrombins - adverse effects Atrial Fibrillation - blood Atrial Fibrillation - complications Atrial Fibrillation - diagnosis Atrial Fibrillation - drug therapy Blood Coagulation - drug effects Chi-Square Distribution Dabigatran - administration & dosage Dabigatran - adverse effects Female Hemorrhage - chemically induced Hemorrhage - prevention & control Humans Kaplan-Meier Estimate Logistic Models Male Middle Aged Propensity Score Proportional Hazards Models Republic of Korea Retrospective Studies Risk Assessment Risk Factors Stroke - blood Stroke - diagnosis Stroke - etiology Stroke - prevention & control Thromboembolism - blood Thromboembolism - diagnosis Thromboembolism - etiology Thromboembolism - prevention & control Time Factors Treatment Outcome Warfarin - administration & dosage Warfarin - adverse effects |
| title | Optimal dose of dabigatran for the prevention of thromboembolism with minimal bleeding risk in Korean patients with atrial fibrillation |
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