Non-vitamin K Antagonist Oral Anticoagulants (NOACs) Versus Warfarin in Patients with Atrial Fibrillation Using P-gp and/or CYP450-Interacting Drugs: a Systematic Review and Meta-analysis
Purpose Non-vitamin K antagonist oral anticoagulants (NOACs) are excreted by P-glycoprotein (P-gp) and some are metabolized by CYP450 enzymes such as CYP3A4. Although fewer drug interactions are present with NOACs, it is unclear whether NOACs should also be preferred over vitamin K antagonists (VKAs...
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| Veröffentlicht in: | Cardiovascular drugs and therapy 2023-08, Vol.37 (4), p.781-791 |
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| creator | Grymonprez, Maxim Vanspranghe, Kevin Steurbaut, Stephane De Backer, Tine L. Lahousse, Lies |
| description | Purpose
Non-vitamin K antagonist oral anticoagulants (NOACs) are excreted by P-glycoprotein (P-gp) and some are metabolized by CYP450 enzymes such as CYP3A4. Although fewer drug interactions are present with NOACs, it is unclear whether NOACs should also be preferred over vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) using pharmacokinetically interacting drugs. Therefore, the benefit-risk profile of NOACs versus VKAs was investigated in AF patients treated with P-gp and/or CYP450-interacting drugs.
Methods
Using PubMed and Embase, randomized controlled trials and observational studies on the effectiveness and safety of NOACs versus VKAs in AF patients using P-gp and/or CYP450-interacting drugs were included. A meta-analysis was performed, calculating relative risks (RR) and 95% confidence intervals (CI) with the Mantel–Haenszel method.
Results
Twelve studies were included, investigating 10,793 NOAC and 10,096 VKA users treated with P-gp/CYP3A4 inhibitors, whereas no studies on P-gp and/or CYP450-inducing drugs were identified. Compared to VKAs, NOACs were associated with a borderline non-significantly lower stroke or systemic embolism (stroke/SE) risk (RR 0.85, 95%CI (0.72–1.01)), significantly lower intracranial bleeding (RR 0.47, 95%CI (0.34–0.65)) and all-cause mortality risks (RR 0.87, 95%CI (0.79–0.95), but significantly higher gastrointestinal bleeding risk (RR 1.74, 95%CI (1.06–2.86)). Among AF patients using amiodarone, NOACs were associated with significantly lower stroke/SE (RR 0.71, 95%CI (0.54–0.93)) and intracranial bleeding risks (RR 0.51, 95%CI (0.29–0.88)), but significantly higher gastrointestinal bleeding risk (RR 2.15, 95%CI (1.24–3.72)) than VKAs.
Conclusion
The benefit-risk profile of NOACs compared to VKAs was preserved in AF patients using P-gp/CYP3A4 inhibitors, including amiodarone. |
| doi_str_mv | 10.1007/s10557-021-07279-8 |
| format | Article |
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Non-vitamin K antagonist oral anticoagulants (NOACs) are excreted by P-glycoprotein (P-gp) and some are metabolized by CYP450 enzymes such as CYP3A4. Although fewer drug interactions are present with NOACs, it is unclear whether NOACs should also be preferred over vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) using pharmacokinetically interacting drugs. Therefore, the benefit-risk profile of NOACs versus VKAs was investigated in AF patients treated with P-gp and/or CYP450-interacting drugs.
Methods
Using PubMed and Embase, randomized controlled trials and observational studies on the effectiveness and safety of NOACs versus VKAs in AF patients using P-gp and/or CYP450-interacting drugs were included. A meta-analysis was performed, calculating relative risks (RR) and 95% confidence intervals (CI) with the Mantel–Haenszel method.
Results
Twelve studies were included, investigating 10,793 NOAC and 10,096 VKA users treated with P-gp/CYP3A4 inhibitors, whereas no studies on P-gp and/or CYP450-inducing drugs were identified. Compared to VKAs, NOACs were associated with a borderline non-significantly lower stroke or systemic embolism (stroke/SE) risk (RR 0.85, 95%CI (0.72–1.01)), significantly lower intracranial bleeding (RR 0.47, 95%CI (0.34–0.65)) and all-cause mortality risks (RR 0.87, 95%CI (0.79–0.95), but significantly higher gastrointestinal bleeding risk (RR 1.74, 95%CI (1.06–2.86)). Among AF patients using amiodarone, NOACs were associated with significantly lower stroke/SE (RR 0.71, 95%CI (0.54–0.93)) and intracranial bleeding risks (RR 0.51, 95%CI (0.29–0.88)), but significantly higher gastrointestinal bleeding risk (RR 2.15, 95%CI (1.24–3.72)) than VKAs.
Conclusion
The benefit-risk profile of NOACs compared to VKAs was preserved in AF patients using P-gp/CYP3A4 inhibitors, including amiodarone.</description><identifier>ISSN: 0920-3206</identifier><identifier>EISSN: 1573-7241</identifier><identifier>DOI: 10.1007/s10557-021-07279-8</identifier><identifier>PMID: 34637052</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Administration, Oral ; Amiodarone ; Amiodarone - therapeutic use ; Antagonists ; Anticoagulants ; Anticoagulants - adverse effects ; ATP Binding Cassette Transporter, Subfamily B, Member 1 ; Atrial Fibrillation - complications ; Atrial Fibrillation - diagnosis ; Atrial Fibrillation - drug therapy ; Bleeding ; Cardiac arrhythmia ; Cardiology ; Clinical trials ; Cytochrome P-450 CYP3A Inhibitors - therapeutic use ; Drug interaction ; Drugs ; Embolism ; Fibrillation ; Gastrointestinal Hemorrhage - chemically induced ; Glycoproteins ; Health risks ; Humans ; Inhibitors ; Intracranial Hemorrhages - chemically induced ; Medicine ; Medicine & Public Health ; Meta-analysis ; Observational studies ; P-Glycoprotein ; Phylloquinone ; Review Article ; Risk assessment ; Stroke ; Stroke - diagnosis ; Stroke - prevention & control ; Vitamin K ; Warfarin - adverse effects</subject><ispartof>Cardiovascular drugs and therapy, 2023-08, Vol.37 (4), p.781-791</ispartof><rights>Springer Science+Business Media, LLC, part of Springer Nature 2021</rights><rights>2021. Springer Science+Business Media, LLC, part of Springer Nature.</rights><rights>Springer Science+Business Media, LLC, part of Springer Nature 2021.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c375t-3d9968a56de3f9891dc03356b033b4d2d3f44d1ed86e5fd300dc4f0b4e6122153</citedby><cites>FETCH-LOGICAL-c375t-3d9968a56de3f9891dc03356b033b4d2d3f44d1ed86e5fd300dc4f0b4e6122153</cites><orcidid>0000-0002-0145-6486</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10557-021-07279-8$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10557-021-07279-8$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34637052$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Grymonprez, Maxim</creatorcontrib><creatorcontrib>Vanspranghe, Kevin</creatorcontrib><creatorcontrib>Steurbaut, Stephane</creatorcontrib><creatorcontrib>De Backer, Tine L.</creatorcontrib><creatorcontrib>Lahousse, Lies</creatorcontrib><title>Non-vitamin K Antagonist Oral Anticoagulants (NOACs) Versus Warfarin in Patients with Atrial Fibrillation Using P-gp and/or CYP450-Interacting Drugs: a Systematic Review and Meta-analysis</title><title>Cardiovascular drugs and therapy</title><addtitle>Cardiovasc Drugs Ther</addtitle><addtitle>Cardiovasc Drugs Ther</addtitle><description>Purpose
Non-vitamin K antagonist oral anticoagulants (NOACs) are excreted by P-glycoprotein (P-gp) and some are metabolized by CYP450 enzymes such as CYP3A4. Although fewer drug interactions are present with NOACs, it is unclear whether NOACs should also be preferred over vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) using pharmacokinetically interacting drugs. Therefore, the benefit-risk profile of NOACs versus VKAs was investigated in AF patients treated with P-gp and/or CYP450-interacting drugs.
Methods
Using PubMed and Embase, randomized controlled trials and observational studies on the effectiveness and safety of NOACs versus VKAs in AF patients using P-gp and/or CYP450-interacting drugs were included. A meta-analysis was performed, calculating relative risks (RR) and 95% confidence intervals (CI) with the Mantel–Haenszel method.
Results
Twelve studies were included, investigating 10,793 NOAC and 10,096 VKA users treated with P-gp/CYP3A4 inhibitors, whereas no studies on P-gp and/or CYP450-inducing drugs were identified. Compared to VKAs, NOACs were associated with a borderline non-significantly lower stroke or systemic embolism (stroke/SE) risk (RR 0.85, 95%CI (0.72–1.01)), significantly lower intracranial bleeding (RR 0.47, 95%CI (0.34–0.65)) and all-cause mortality risks (RR 0.87, 95%CI (0.79–0.95), but significantly higher gastrointestinal bleeding risk (RR 1.74, 95%CI (1.06–2.86)). Among AF patients using amiodarone, NOACs were associated with significantly lower stroke/SE (RR 0.71, 95%CI (0.54–0.93)) and intracranial bleeding risks (RR 0.51, 95%CI (0.29–0.88)), but significantly higher gastrointestinal bleeding risk (RR 2.15, 95%CI (1.24–3.72)) than VKAs.
Conclusion
The benefit-risk profile of NOACs compared to VKAs was preserved in AF patients using P-gp/CYP3A4 inhibitors, including amiodarone.</description><subject>Administration, Oral</subject><subject>Amiodarone</subject><subject>Amiodarone - therapeutic use</subject><subject>Antagonists</subject><subject>Anticoagulants</subject><subject>Anticoagulants - adverse effects</subject><subject>ATP Binding Cassette Transporter, Subfamily B, Member 1</subject><subject>Atrial Fibrillation - complications</subject><subject>Atrial Fibrillation - diagnosis</subject><subject>Atrial Fibrillation - drug therapy</subject><subject>Bleeding</subject><subject>Cardiac arrhythmia</subject><subject>Cardiology</subject><subject>Clinical trials</subject><subject>Cytochrome P-450 CYP3A Inhibitors - therapeutic use</subject><subject>Drug interaction</subject><subject>Drugs</subject><subject>Embolism</subject><subject>Fibrillation</subject><subject>Gastrointestinal Hemorrhage - chemically induced</subject><subject>Glycoproteins</subject><subject>Health risks</subject><subject>Humans</subject><subject>Inhibitors</subject><subject>Intracranial Hemorrhages - chemically induced</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Meta-analysis</subject><subject>Observational studies</subject><subject>P-Glycoprotein</subject><subject>Phylloquinone</subject><subject>Review Article</subject><subject>Risk assessment</subject><subject>Stroke</subject><subject>Stroke - diagnosis</subject><subject>Stroke - prevention & control</subject><subject>Vitamin K</subject><subject>Warfarin - adverse effects</subject><issn>0920-3206</issn><issn>1573-7241</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp9kc1u1DAUhS0EokPhBVggS2zKwtS_ScxuNFCoKJ0RUBCryImd4CrjDL5Oq3k2Xg6HKbBDsmxZ53znWj4IPWX0JaO0PAVGlSoJ5YzQkpeaVPfQgqlSkJJLdh8tqOaUCE6LI_QI4JpmSOvqIToSshAlVXyBfl6Ogdz4ZLY-4Pd4GZLpx-Ah4XU0w3z37Wj6aTAhAT65XC9X8AJ_cREmwF9N7EzMYF4bk7ybPbc-fcfLFH3Gz3wT_TBkaQz4Cnzo8Yb0O2yCPR0jXn3bSEXJeUgumjbN8us49fAKG_xpD8ltM9nij-7Gu9sZwh9cMsQEM-zBw2P0oDMDuCd35zG6OnvzefWOXKzfnq-WF6QVpUpEWK2LyqjCOtHpSjPbUiFU0eS9kZZb0UlpmbNV4VRnBaW2lR1tpCsY50yJY_T8kLuL44_JQaqvxynmR0DNKynzJ5dUZxc_uNo4AkTX1bvotybua0brua_60Fed-6p_91VXGXp2Fz01W2f_In8KygZxMECWQu_iv9n_if0FEBqhjA</recordid><startdate>20230801</startdate><enddate>20230801</enddate><creator>Grymonprez, Maxim</creator><creator>Vanspranghe, Kevin</creator><creator>Steurbaut, Stephane</creator><creator>De Backer, Tine L.</creator><creator>Lahousse, Lies</creator><general>Springer US</general><general>Springer Nature B.V</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>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M7Z</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><orcidid>https://orcid.org/0000-0002-0145-6486</orcidid></search><sort><creationdate>20230801</creationdate><title>Non-vitamin K Antagonist Oral Anticoagulants (NOACs) Versus Warfarin in Patients with Atrial Fibrillation Using P-gp and/or CYP450-Interacting Drugs: a Systematic Review and Meta-analysis</title><author>Grymonprez, Maxim ; Vanspranghe, Kevin ; Steurbaut, Stephane ; De Backer, Tine L. ; Lahousse, Lies</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c375t-3d9968a56de3f9891dc03356b033b4d2d3f44d1ed86e5fd300dc4f0b4e6122153</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Administration, Oral</topic><topic>Amiodarone</topic><topic>Amiodarone - therapeutic use</topic><topic>Antagonists</topic><topic>Anticoagulants</topic><topic>Anticoagulants - adverse effects</topic><topic>ATP Binding Cassette Transporter, Subfamily B, Member 1</topic><topic>Atrial Fibrillation - complications</topic><topic>Atrial Fibrillation - diagnosis</topic><topic>Atrial Fibrillation - drug therapy</topic><topic>Bleeding</topic><topic>Cardiac arrhythmia</topic><topic>Cardiology</topic><topic>Clinical trials</topic><topic>Cytochrome P-450 CYP3A Inhibitors - therapeutic use</topic><topic>Drug interaction</topic><topic>Drugs</topic><topic>Embolism</topic><topic>Fibrillation</topic><topic>Gastrointestinal Hemorrhage - chemically induced</topic><topic>Glycoproteins</topic><topic>Health risks</topic><topic>Humans</topic><topic>Inhibitors</topic><topic>Intracranial Hemorrhages - chemically induced</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Meta-analysis</topic><topic>Observational studies</topic><topic>P-Glycoprotein</topic><topic>Phylloquinone</topic><topic>Review Article</topic><topic>Risk assessment</topic><topic>Stroke</topic><topic>Stroke - diagnosis</topic><topic>Stroke - prevention & control</topic><topic>Vitamin K</topic><topic>Warfarin - adverse effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Grymonprez, Maxim</creatorcontrib><creatorcontrib>Vanspranghe, Kevin</creatorcontrib><creatorcontrib>Steurbaut, Stephane</creatorcontrib><creatorcontrib>De Backer, Tine L.</creatorcontrib><creatorcontrib>Lahousse, Lies</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Biochemistry Abstracts 1</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><jtitle>Cardiovascular drugs and therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Grymonprez, Maxim</au><au>Vanspranghe, Kevin</au><au>Steurbaut, Stephane</au><au>De Backer, Tine L.</au><au>Lahousse, Lies</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Non-vitamin K Antagonist Oral Anticoagulants (NOACs) Versus Warfarin in Patients with Atrial Fibrillation Using P-gp and/or CYP450-Interacting Drugs: a Systematic Review and Meta-analysis</atitle><jtitle>Cardiovascular drugs and therapy</jtitle><stitle>Cardiovasc Drugs Ther</stitle><addtitle>Cardiovasc Drugs Ther</addtitle><date>2023-08-01</date><risdate>2023</risdate><volume>37</volume><issue>4</issue><spage>781</spage><epage>791</epage><pages>781-791</pages><issn>0920-3206</issn><eissn>1573-7241</eissn><abstract>Purpose
Non-vitamin K antagonist oral anticoagulants (NOACs) are excreted by P-glycoprotein (P-gp) and some are metabolized by CYP450 enzymes such as CYP3A4. Although fewer drug interactions are present with NOACs, it is unclear whether NOACs should also be preferred over vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) using pharmacokinetically interacting drugs. Therefore, the benefit-risk profile of NOACs versus VKAs was investigated in AF patients treated with P-gp and/or CYP450-interacting drugs.
Methods
Using PubMed and Embase, randomized controlled trials and observational studies on the effectiveness and safety of NOACs versus VKAs in AF patients using P-gp and/or CYP450-interacting drugs were included. A meta-analysis was performed, calculating relative risks (RR) and 95% confidence intervals (CI) with the Mantel–Haenszel method.
Results
Twelve studies were included, investigating 10,793 NOAC and 10,096 VKA users treated with P-gp/CYP3A4 inhibitors, whereas no studies on P-gp and/or CYP450-inducing drugs were identified. Compared to VKAs, NOACs were associated with a borderline non-significantly lower stroke or systemic embolism (stroke/SE) risk (RR 0.85, 95%CI (0.72–1.01)), significantly lower intracranial bleeding (RR 0.47, 95%CI (0.34–0.65)) and all-cause mortality risks (RR 0.87, 95%CI (0.79–0.95), but significantly higher gastrointestinal bleeding risk (RR 1.74, 95%CI (1.06–2.86)). Among AF patients using amiodarone, NOACs were associated with significantly lower stroke/SE (RR 0.71, 95%CI (0.54–0.93)) and intracranial bleeding risks (RR 0.51, 95%CI (0.29–0.88)), but significantly higher gastrointestinal bleeding risk (RR 2.15, 95%CI (1.24–3.72)) than VKAs.
Conclusion
The benefit-risk profile of NOACs compared to VKAs was preserved in AF patients using P-gp/CYP3A4 inhibitors, including amiodarone.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>34637052</pmid><doi>10.1007/s10557-021-07279-8</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0002-0145-6486</orcidid></addata></record> |
| fulltext | fulltext |
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| ispartof | Cardiovascular drugs and therapy, 2023-08, Vol.37 (4), p.781-791 |
| issn | 0920-3206 1573-7241 |
| language | eng |
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| source | MEDLINE; SpringerLink Journals - AutoHoldings |
| subjects | Administration, Oral Amiodarone Amiodarone - therapeutic use Antagonists Anticoagulants Anticoagulants - adverse effects ATP Binding Cassette Transporter, Subfamily B, Member 1 Atrial Fibrillation - complications Atrial Fibrillation - diagnosis Atrial Fibrillation - drug therapy Bleeding Cardiac arrhythmia Cardiology Clinical trials Cytochrome P-450 CYP3A Inhibitors - therapeutic use Drug interaction Drugs Embolism Fibrillation Gastrointestinal Hemorrhage - chemically induced Glycoproteins Health risks Humans Inhibitors Intracranial Hemorrhages - chemically induced Medicine Medicine & Public Health Meta-analysis Observational studies P-Glycoprotein Phylloquinone Review Article Risk assessment Stroke Stroke - diagnosis Stroke - prevention & control Vitamin K Warfarin - adverse effects |
| title | Non-vitamin K Antagonist Oral Anticoagulants (NOACs) Versus Warfarin in Patients with Atrial Fibrillation Using P-gp and/or CYP450-Interacting Drugs: a Systematic Review and Meta-analysis |
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