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A multicenter, open-label study of vernakalant for the conversion of atrial fibrillation to sinus rhythm
Background The efficacy and safety of vernakalant, a relatively atrial-selective antiarrhythmic agent, in converting atrial fibrillation (AF) to sinus rhythm (SR) were evaluated in this multicenter, open-label study of patients with AF lasting >3 hours and ≤45 days (RCT no. NCT00281554 ). Methods...
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| Published in: | The American heart journal 2010-06, Vol.159 (6), p.1095-1101 |
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| creator | Stiell, Ian G., MD Roos, Johan S., MD Kavanagh, Katherine M., MD Dickinson, Garth, MD |
| description | Background The efficacy and safety of vernakalant, a relatively atrial-selective antiarrhythmic agent, in converting atrial fibrillation (AF) to sinus rhythm (SR) were evaluated in this multicenter, open-label study of patients with AF lasting >3 hours and ≤45 days (RCT no. NCT00281554 ). Methods Adult patients with AF and an indication for conversion to SR received a 10-minute intravenous infusion of vernakalant (3 mg/kg). If after a 15-minute observation period AF was present, a second 10-minute infusion of intravenous vernakalant (2 mg/kg) was given. The primary efficacy end point was the proportion of patients with recent-onset AF (AF lasting >3 hours to ≤7 days) who converted to SR within 90 minutes of the start of the first infusion. Safety evaluations included vital signs, telemetry and Holter monitoring, 12-lead electrocardiography, clinical laboratory tests, physical examinations, and adverse events (AEs). Results A total of 236 hemodynamically stable patients with AF received intravenous vernakalant. Among them, 167 (71%) had recent-onset AF and were eligible for the primary efficacy end point. Vernakalant rapidly converted recent-onset AF to SR in 50.9% of patients, with a median time to conversion of 14 minutes among responders. The most common AEs were dysgeusia, sneezing, and paresthesia. These occurred at the time of vernakalant infusion, were transient, and resolved spontaneously. Ten patients (4.2%) discontinued vernakalant treatment because of AEs, most commonly (in 4 of 10) hypotension. There were no episodes of torsades de pointes, ventricular fibrillation, or sustained ventricular tachycardia. Conclusions Vernakalant rapidly converted recent-onset AF to SR, was well tolerated, and may be a valuable therapeutic alternative for reestablishing SR in patients with recent-onset AF. |
| doi_str_mv | 10.1016/j.ahj.2010.02.035 |
| format | article |
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NCT00281554 ). Methods Adult patients with AF and an indication for conversion to SR received a 10-minute intravenous infusion of vernakalant (3 mg/kg). If after a 15-minute observation period AF was present, a second 10-minute infusion of intravenous vernakalant (2 mg/kg) was given. The primary efficacy end point was the proportion of patients with recent-onset AF (AF lasting >3 hours to ≤7 days) who converted to SR within 90 minutes of the start of the first infusion. Safety evaluations included vital signs, telemetry and Holter monitoring, 12-lead electrocardiography, clinical laboratory tests, physical examinations, and adverse events (AEs). Results A total of 236 hemodynamically stable patients with AF received intravenous vernakalant. Among them, 167 (71%) had recent-onset AF and were eligible for the primary efficacy end point. Vernakalant rapidly converted recent-onset AF to SR in 50.9% of patients, with a median time to conversion of 14 minutes among responders. The most common AEs were dysgeusia, sneezing, and paresthesia. These occurred at the time of vernakalant infusion, were transient, and resolved spontaneously. Ten patients (4.2%) discontinued vernakalant treatment because of AEs, most commonly (in 4 of 10) hypotension. There were no episodes of torsades de pointes, ventricular fibrillation, or sustained ventricular tachycardia. Conclusions Vernakalant rapidly converted recent-onset AF to SR, was well tolerated, and may be a valuable therapeutic alternative for reestablishing SR in patients with recent-onset AF.</description><identifier>ISSN: 0002-8703</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1016/j.ahj.2010.02.035</identifier><identifier>PMID: 20569725</identifier><identifier>CODEN: AHJOA2</identifier><language>eng</language><publisher>New York, NY: Mosby, Inc</publisher><subject>Acute coronary syndromes ; Aged ; Anisoles - administration & dosage ; Anisoles - therapeutic use ; Atrial Fibrillation - drug therapy ; Atrial Fibrillation - physiopathology ; Biological and medical sciences ; Cardiac arrhythmia ; Cardiac dysrhythmias ; Cardiology. Vascular system ; Cardiomyopathy ; Cardiovascular ; Dose-Response Relationship, Drug ; Drug therapy ; Electrocardiography - drug effects ; Female ; Follow-Up Studies ; Heart ; Heart attacks ; Heart failure ; Heart rate ; Heart Rate - drug effects ; Heart Rate - physiology ; Humans ; Infusions, Intravenous ; Male ; Medical sciences ; Middle Aged ; Mortality ; Pyrrolidines - administration & dosage ; Pyrrolidines - therapeutic use ; Sinoatrial Node - drug effects ; Sinoatrial Node - physiopathology ; Sinuses ; Statistical methods ; Treatment Outcome</subject><ispartof>The American heart journal, 2010-06, Vol.159 (6), p.1095-1101</ispartof><rights>Mosby, Inc.</rights><rights>2010 Mosby, Inc.</rights><rights>2015 INIST-CNRS</rights><rights>Copyright 2010 Mosby, Inc. All rights reserved.</rights><rights>Copyright Elsevier Limited Jun 2010</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c465t-8908300f208e47ed0b8ce52e603ce774fcc717d6ec34f9c7f4c9ed885d3d21f63</citedby><cites>FETCH-LOGICAL-c465t-8908300f208e47ed0b8ce52e603ce774fcc717d6ec34f9c7f4c9ed885d3d21f63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,786,790,27957,27958</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22919577$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20569725$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Stiell, Ian G., MD</creatorcontrib><creatorcontrib>Roos, Johan S., MD</creatorcontrib><creatorcontrib>Kavanagh, Katherine M., MD</creatorcontrib><creatorcontrib>Dickinson, Garth, MD</creatorcontrib><title>A multicenter, open-label study of vernakalant for the conversion of atrial fibrillation to sinus rhythm</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>Background The efficacy and safety of vernakalant, a relatively atrial-selective antiarrhythmic agent, in converting atrial fibrillation (AF) to sinus rhythm (SR) were evaluated in this multicenter, open-label study of patients with AF lasting >3 hours and ≤45 days (RCT no. NCT00281554 ). Methods Adult patients with AF and an indication for conversion to SR received a 10-minute intravenous infusion of vernakalant (3 mg/kg). If after a 15-minute observation period AF was present, a second 10-minute infusion of intravenous vernakalant (2 mg/kg) was given. The primary efficacy end point was the proportion of patients with recent-onset AF (AF lasting >3 hours to ≤7 days) who converted to SR within 90 minutes of the start of the first infusion. Safety evaluations included vital signs, telemetry and Holter monitoring, 12-lead electrocardiography, clinical laboratory tests, physical examinations, and adverse events (AEs). Results A total of 236 hemodynamically stable patients with AF received intravenous vernakalant. Among them, 167 (71%) had recent-onset AF and were eligible for the primary efficacy end point. Vernakalant rapidly converted recent-onset AF to SR in 50.9% of patients, with a median time to conversion of 14 minutes among responders. The most common AEs were dysgeusia, sneezing, and paresthesia. These occurred at the time of vernakalant infusion, were transient, and resolved spontaneously. Ten patients (4.2%) discontinued vernakalant treatment because of AEs, most commonly (in 4 of 10) hypotension. There were no episodes of torsades de pointes, ventricular fibrillation, or sustained ventricular tachycardia. Conclusions Vernakalant rapidly converted recent-onset AF to SR, was well tolerated, and may be a valuable therapeutic alternative for reestablishing SR in patients with recent-onset AF.</description><subject>Acute coronary syndromes</subject><subject>Aged</subject><subject>Anisoles - administration & dosage</subject><subject>Anisoles - therapeutic use</subject><subject>Atrial Fibrillation - drug therapy</subject><subject>Atrial Fibrillation - physiopathology</subject><subject>Biological and medical sciences</subject><subject>Cardiac arrhythmia</subject><subject>Cardiac dysrhythmias</subject><subject>Cardiology. Vascular system</subject><subject>Cardiomyopathy</subject><subject>Cardiovascular</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug therapy</subject><subject>Electrocardiography - drug effects</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Heart</subject><subject>Heart attacks</subject><subject>Heart failure</subject><subject>Heart rate</subject><subject>Heart Rate - drug effects</subject><subject>Heart Rate - physiology</subject><subject>Humans</subject><subject>Infusions, Intravenous</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Mortality</subject><subject>Pyrrolidines - administration & dosage</subject><subject>Pyrrolidines - therapeutic use</subject><subject>Sinoatrial Node - drug effects</subject><subject>Sinoatrial Node - physiopathology</subject><subject>Sinuses</subject><subject>Statistical methods</subject><subject>Treatment Outcome</subject><issn>0002-8703</issn><issn>1097-6744</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><recordid>eNp9kk2LFDEQhhtR3HH1B3iRBhEv9lj56nQjCMviFyx4UM8hk64wmc0kY5JemH9vmhld2IOnJMXzVqrqraZ5SWBNgPTvd2u93a0p1DfQNTDxqFkRGGXXS84fNysAoN0ggV00z3Le1WdPh_5pc0FB9KOkYtVsr9r97IszGAqmd208YOi83qBvc5mnYxtte4cp6FvtdSitjaktW2xNDDWcXQwLoUty2rfWbZLzXpclXGKbXZhzm7bHst0_b55Y7TO-OJ-Xza_Pn35ef-1uvn_5dn110xnei9INIwwMwFIYkEucYDMYFBR7YAal5NYYSeTUo2HcjkZabkachkFMbKLE9uyyeXvKe0jx94y5qL3LBmtVAeOclWSMAx8lr-TrB-QuzrVTnxURwIUQVCwUOVEmxZwTWnVIbq_TURFQiwtqp6oLanFBAVXVhap5dc48b_Y4_VP8HXsF3pwBnY32NulgXL7n6EhGIWXlPpw4rBO7c5hUNg6DwcklNEVN0f23jI8P1Ma74OqHt3jEfN-tylWgfizrsmwLWS4MRvYHu_O5ng</recordid><startdate>20100601</startdate><enddate>20100601</enddate><creator>Stiell, Ian G., MD</creator><creator>Roos, Johan S., MD</creator><creator>Kavanagh, Katherine M., MD</creator><creator>Dickinson, Garth, MD</creator><general>Mosby, Inc</general><general>Mosby</general><general>Elsevier Limited</general><scope>IQODW</scope><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>7QO</scope><scope>7RV</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20100601</creationdate><title>A multicenter, open-label study of vernakalant for the conversion of atrial fibrillation to sinus rhythm</title><author>Stiell, Ian G., MD ; Roos, Johan S., MD ; Kavanagh, Katherine M., MD ; Dickinson, Garth, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c465t-8908300f208e47ed0b8ce52e603ce774fcc717d6ec34f9c7f4c9ed885d3d21f63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Acute coronary syndromes</topic><topic>Aged</topic><topic>Anisoles - administration & dosage</topic><topic>Anisoles - therapeutic use</topic><topic>Atrial Fibrillation - drug therapy</topic><topic>Atrial Fibrillation - physiopathology</topic><topic>Biological and medical sciences</topic><topic>Cardiac arrhythmia</topic><topic>Cardiac dysrhythmias</topic><topic>Cardiology. Vascular system</topic><topic>Cardiomyopathy</topic><topic>Cardiovascular</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug therapy</topic><topic>Electrocardiography - drug effects</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Heart</topic><topic>Heart attacks</topic><topic>Heart failure</topic><topic>Heart rate</topic><topic>Heart Rate - drug effects</topic><topic>Heart Rate - physiology</topic><topic>Humans</topic><topic>Infusions, Intravenous</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Mortality</topic><topic>Pyrrolidines - administration & dosage</topic><topic>Pyrrolidines - therapeutic use</topic><topic>Sinoatrial Node - drug effects</topic><topic>Sinoatrial Node - physiopathology</topic><topic>Sinuses</topic><topic>Statistical methods</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Stiell, Ian G., MD</creatorcontrib><creatorcontrib>Roos, Johan S., MD</creatorcontrib><creatorcontrib>Kavanagh, Katherine M., MD</creatorcontrib><creatorcontrib>Dickinson, Garth, MD</creatorcontrib><collection>Pascal-Francis</collection><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>Biotechnology Research Abstracts</collection><collection>ProQuest Nursing and Allied Health Journals</collection><collection>Physical Education Index</collection><collection>ProQuest - 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Academic</collection><jtitle>The American heart journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Stiell, Ian G., MD</au><au>Roos, Johan S., MD</au><au>Kavanagh, Katherine M., MD</au><au>Dickinson, Garth, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A multicenter, open-label study of vernakalant for the conversion of atrial fibrillation to sinus rhythm</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>2010-06-01</date><risdate>2010</risdate><volume>159</volume><issue>6</issue><spage>1095</spage><epage>1101</epage><pages>1095-1101</pages><issn>0002-8703</issn><eissn>1097-6744</eissn><coden>AHJOA2</coden><notes>ObjectType-Article-1</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-News-2</notes><notes>ObjectType-Feature-3</notes><notes>content type line 23</notes><abstract>Background The efficacy and safety of vernakalant, a relatively atrial-selective antiarrhythmic agent, in converting atrial fibrillation (AF) to sinus rhythm (SR) were evaluated in this multicenter, open-label study of patients with AF lasting >3 hours and ≤45 days (RCT no. NCT00281554 ). Methods Adult patients with AF and an indication for conversion to SR received a 10-minute intravenous infusion of vernakalant (3 mg/kg). If after a 15-minute observation period AF was present, a second 10-minute infusion of intravenous vernakalant (2 mg/kg) was given. The primary efficacy end point was the proportion of patients with recent-onset AF (AF lasting >3 hours to ≤7 days) who converted to SR within 90 minutes of the start of the first infusion. Safety evaluations included vital signs, telemetry and Holter monitoring, 12-lead electrocardiography, clinical laboratory tests, physical examinations, and adverse events (AEs). Results A total of 236 hemodynamically stable patients with AF received intravenous vernakalant. Among them, 167 (71%) had recent-onset AF and were eligible for the primary efficacy end point. Vernakalant rapidly converted recent-onset AF to SR in 50.9% of patients, with a median time to conversion of 14 minutes among responders. The most common AEs were dysgeusia, sneezing, and paresthesia. These occurred at the time of vernakalant infusion, were transient, and resolved spontaneously. Ten patients (4.2%) discontinued vernakalant treatment because of AEs, most commonly (in 4 of 10) hypotension. There were no episodes of torsades de pointes, ventricular fibrillation, or sustained ventricular tachycardia. Conclusions Vernakalant rapidly converted recent-onset AF to SR, was well tolerated, and may be a valuable therapeutic alternative for reestablishing SR in patients with recent-onset AF.</abstract><cop>New York, NY</cop><pub>Mosby, Inc</pub><pmid>20569725</pmid><doi>10.1016/j.ahj.2010.02.035</doi><tpages>7</tpages></addata></record> |
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| subjects | Acute coronary syndromes Aged Anisoles - administration & dosage Anisoles - therapeutic use Atrial Fibrillation - drug therapy Atrial Fibrillation - physiopathology Biological and medical sciences Cardiac arrhythmia Cardiac dysrhythmias Cardiology. Vascular system Cardiomyopathy Cardiovascular Dose-Response Relationship, Drug Drug therapy Electrocardiography - drug effects Female Follow-Up Studies Heart Heart attacks Heart failure Heart rate Heart Rate - drug effects Heart Rate - physiology Humans Infusions, Intravenous Male Medical sciences Middle Aged Mortality Pyrrolidines - administration & dosage Pyrrolidines - therapeutic use Sinoatrial Node - drug effects Sinoatrial Node - physiopathology Sinuses Statistical methods Treatment Outcome |
| title | A multicenter, open-label study of vernakalant for the conversion of atrial fibrillation to sinus rhythm |
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