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Efficacy and safety of intravenously administered dofetilide in acute termination of atrial fibrillation and flutter: a multicenter, randomized, double-blind, placebo-controlled trial. Danish Dofetilide in Atrial Fibrillation and Flutter Study Group
This study was designed to assess the efficacy and safety of intravenous dofetilide in acute termination of atrial fibrillation (AF) and flutter (AFL). Dofetilide, an investigational class III antiarrhythmic agent, selectively inhibits the rapid component of the delayed rectifier potassium current,...
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| Published in: | The American heart journal 1999-06, Vol.137 (6), p.1062 |
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| container_title | The American heart journal |
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| creator | Nørgaard, B L Wachtell, K Christensen, P D Madsen, B Johansen, J B Christiansen, E H Graff, O Simonsen, E H |
| description | This study was designed to assess the efficacy and safety of intravenous dofetilide in acute termination of atrial fibrillation (AF) and flutter (AFL). Dofetilide, an investigational class III antiarrhythmic agent, selectively inhibits the rapid component of the delayed rectifier potassium current, thus prolonging the effective refractory period and duration of the action potential. Dofetilide can be administered intravenously and has a rapid onset of electrophysiologic action.
Ninety-six patients with AF (n = 79) or AFL (n = 17) with a median arrhythmia duration of 62 days (range 1 to 180) were randomized to placebo (n = 30) or 8 micrograms/kg IV dofetilide (n = 66) over 30 minutes. Conversion was defined as termination of the atrial arrhythmia within 3 hours from the start of infusion. The conversion rate was 30.3% after dofetilide and 3.3% after placebo (P |
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Ninety-six patients with AF (n = 79) or AFL (n = 17) with a median arrhythmia duration of 62 days (range 1 to 180) were randomized to placebo (n = 30) or 8 micrograms/kg IV dofetilide (n = 66) over 30 minutes. Conversion was defined as termination of the atrial arrhythmia within 3 hours from the start of infusion. The conversion rate was 30.3% after dofetilide and 3.3% after placebo (P <.006). Conversion rate was higher in AFL than in AF: 64% versus 24% (P =. 012). In nonconverters, there was no statistically significant difference between the change in heart rate among the dofetilide-treated compared with the placebo-treated patients (P =. 42). Torsade de pointes ventricular tachycardia developed in 2 patients (3%). In both patients, drug infusion was discontinued before the event because of prolongation of the QT interval.
Intravenous dofetilide is effective in acute termination of AF and AFL of medium duration, with a particularly high efficacy rate in AFL. A small but serious risk of proarrhythmia must be anticipated.</description><identifier>ISSN: 0002-8703</identifier><identifier>PMID: 10347332</identifier><language>eng</language><publisher>United States</publisher><subject>Aged ; Anti-Arrhythmia Agents - administration & dosage ; Anti-Arrhythmia Agents - adverse effects ; Anti-Arrhythmia Agents - pharmacokinetics ; Atrial Fibrillation - blood ; Atrial Fibrillation - drug therapy ; Atrial Fibrillation - physiopathology ; Atrial Flutter - blood ; Atrial Flutter - drug therapy ; Atrial Flutter - physiopathology ; Denmark ; Double-Blind Method ; Female ; Hemodynamics - drug effects ; Humans ; Infusions, Intravenous ; Male ; Middle Aged ; Phenethylamines - administration & dosage ; Phenethylamines - adverse effects ; Phenethylamines - pharmacokinetics ; Placebos ; Potassium Channel Blockers ; Prospective Studies ; Safety ; Sulfonamides - administration & dosage ; Sulfonamides - adverse effects ; Sulfonamides - pharmacokinetics ; Time Factors</subject><ispartof>The American heart journal, 1999-06, Vol.137 (6), p.1062</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/10347332$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nørgaard, B L</creatorcontrib><creatorcontrib>Wachtell, K</creatorcontrib><creatorcontrib>Christensen, P D</creatorcontrib><creatorcontrib>Madsen, B</creatorcontrib><creatorcontrib>Johansen, J B</creatorcontrib><creatorcontrib>Christiansen, E H</creatorcontrib><creatorcontrib>Graff, O</creatorcontrib><creatorcontrib>Simonsen, E H</creatorcontrib><title>Efficacy and safety of intravenously administered dofetilide in acute termination of atrial fibrillation and flutter: a multicenter, randomized, double-blind, placebo-controlled trial. Danish Dofetilide in Atrial Fibrillation and Flutter Study Group</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>This study was designed to assess the efficacy and safety of intravenous dofetilide in acute termination of atrial fibrillation (AF) and flutter (AFL). Dofetilide, an investigational class III antiarrhythmic agent, selectively inhibits the rapid component of the delayed rectifier potassium current, thus prolonging the effective refractory period and duration of the action potential. Dofetilide can be administered intravenously and has a rapid onset of electrophysiologic action.
Ninety-six patients with AF (n = 79) or AFL (n = 17) with a median arrhythmia duration of 62 days (range 1 to 180) were randomized to placebo (n = 30) or 8 micrograms/kg IV dofetilide (n = 66) over 30 minutes. Conversion was defined as termination of the atrial arrhythmia within 3 hours from the start of infusion. The conversion rate was 30.3% after dofetilide and 3.3% after placebo (P <.006). Conversion rate was higher in AFL than in AF: 64% versus 24% (P =. 012). In nonconverters, there was no statistically significant difference between the change in heart rate among the dofetilide-treated compared with the placebo-treated patients (P =. 42). Torsade de pointes ventricular tachycardia developed in 2 patients (3%). In both patients, drug infusion was discontinued before the event because of prolongation of the QT interval.
Intravenous dofetilide is effective in acute termination of AF and AFL of medium duration, with a particularly high efficacy rate in AFL. A small but serious risk of proarrhythmia must be anticipated.</description><subject>Aged</subject><subject>Anti-Arrhythmia Agents - administration & dosage</subject><subject>Anti-Arrhythmia Agents - adverse effects</subject><subject>Anti-Arrhythmia Agents - pharmacokinetics</subject><subject>Atrial Fibrillation - blood</subject><subject>Atrial Fibrillation - drug therapy</subject><subject>Atrial Fibrillation - physiopathology</subject><subject>Atrial Flutter - blood</subject><subject>Atrial Flutter - drug therapy</subject><subject>Atrial Flutter - physiopathology</subject><subject>Denmark</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Hemodynamics - drug effects</subject><subject>Humans</subject><subject>Infusions, Intravenous</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Phenethylamines - administration & dosage</subject><subject>Phenethylamines - adverse effects</subject><subject>Phenethylamines - pharmacokinetics</subject><subject>Placebos</subject><subject>Potassium Channel Blockers</subject><subject>Prospective Studies</subject><subject>Safety</subject><subject>Sulfonamides - administration & dosage</subject><subject>Sulfonamides - adverse effects</subject><subject>Sulfonamides - pharmacokinetics</subject><subject>Time Factors</subject><issn>0002-8703</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1999</creationdate><recordtype>article</recordtype><recordid>eNpdUctOwzAQzAFES-EXkD-gQY6dh8ut6gukShzovfJjLYycOHJspPLn3HAJHOC0mp3ZmZH2IptijEnOGkwn2fUwvCVYE1ZfZZMC07KhlEyzz43WRnJ5QrxTaOAawgk5jUwXPH-HzsXBJk61pjNDAA8KKZdExhoFSYW4jAFQYpKCB-O68zUP3nCLtBHeWDuuz_7axpCkD4ijNtpgJHQJzpFPpGvNB6h5so_CQi6s6RLqLZcgXC5dKuSsTfnf3vdozVOjV7T-02Y5Bm__B2_HYPQSojqhnXexv8kuNbcD3P7MWXbYbg6rx3z_vHtaLfd5X5UkB16VTYGJLGqmqkJhvQAoa0aoAMYwwYRVStVEAW0UBoZZUxVci0VBail0Q2fZ3WjbR9GCOvbetNyfjr8voF_y_Yjf</recordid><startdate>199906</startdate><enddate>199906</enddate><creator>Nørgaard, B L</creator><creator>Wachtell, K</creator><creator>Christensen, P D</creator><creator>Madsen, B</creator><creator>Johansen, J B</creator><creator>Christiansen, E H</creator><creator>Graff, O</creator><creator>Simonsen, E H</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope></search><sort><creationdate>199906</creationdate><title>Efficacy and safety of intravenously administered dofetilide in acute termination of atrial fibrillation and flutter: a multicenter, randomized, double-blind, placebo-controlled trial. Danish Dofetilide in Atrial Fibrillation and Flutter Study Group</title><author>Nørgaard, B L ; Wachtell, K ; Christensen, P D ; Madsen, B ; Johansen, J B ; Christiansen, E H ; Graff, O ; Simonsen, E H</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p542-ea547102c168d51d0f9ee46823be88020285dd62de37d0e808751afb9126cbf73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1999</creationdate><topic>Aged</topic><topic>Anti-Arrhythmia Agents - administration & dosage</topic><topic>Anti-Arrhythmia Agents - adverse effects</topic><topic>Anti-Arrhythmia Agents - pharmacokinetics</topic><topic>Atrial Fibrillation - blood</topic><topic>Atrial Fibrillation - drug therapy</topic><topic>Atrial Fibrillation - physiopathology</topic><topic>Atrial Flutter - blood</topic><topic>Atrial Flutter - drug therapy</topic><topic>Atrial Flutter - physiopathology</topic><topic>Denmark</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Hemodynamics - drug effects</topic><topic>Humans</topic><topic>Infusions, Intravenous</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Phenethylamines - administration & dosage</topic><topic>Phenethylamines - adverse effects</topic><topic>Phenethylamines - pharmacokinetics</topic><topic>Placebos</topic><topic>Potassium Channel Blockers</topic><topic>Prospective Studies</topic><topic>Safety</topic><topic>Sulfonamides - administration & dosage</topic><topic>Sulfonamides - adverse effects</topic><topic>Sulfonamides - pharmacokinetics</topic><topic>Time Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nørgaard, B L</creatorcontrib><creatorcontrib>Wachtell, K</creatorcontrib><creatorcontrib>Christensen, P D</creatorcontrib><creatorcontrib>Madsen, B</creatorcontrib><creatorcontrib>Johansen, J B</creatorcontrib><creatorcontrib>Christiansen, E H</creatorcontrib><creatorcontrib>Graff, O</creatorcontrib><creatorcontrib>Simonsen, E H</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><jtitle>The American heart journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nørgaard, B L</au><au>Wachtell, K</au><au>Christensen, P D</au><au>Madsen, B</au><au>Johansen, J B</au><au>Christiansen, E H</au><au>Graff, O</au><au>Simonsen, E H</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of intravenously administered dofetilide in acute termination of atrial fibrillation and flutter: a multicenter, randomized, double-blind, placebo-controlled trial. Danish Dofetilide in Atrial Fibrillation and Flutter Study Group</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>1999-06</date><risdate>1999</risdate><volume>137</volume><issue>6</issue><spage>1062</spage><pages>1062-</pages><issn>0002-8703</issn><abstract>This study was designed to assess the efficacy and safety of intravenous dofetilide in acute termination of atrial fibrillation (AF) and flutter (AFL). Dofetilide, an investigational class III antiarrhythmic agent, selectively inhibits the rapid component of the delayed rectifier potassium current, thus prolonging the effective refractory period and duration of the action potential. Dofetilide can be administered intravenously and has a rapid onset of electrophysiologic action.
Ninety-six patients with AF (n = 79) or AFL (n = 17) with a median arrhythmia duration of 62 days (range 1 to 180) were randomized to placebo (n = 30) or 8 micrograms/kg IV dofetilide (n = 66) over 30 minutes. Conversion was defined as termination of the atrial arrhythmia within 3 hours from the start of infusion. The conversion rate was 30.3% after dofetilide and 3.3% after placebo (P <.006). Conversion rate was higher in AFL than in AF: 64% versus 24% (P =. 012). In nonconverters, there was no statistically significant difference between the change in heart rate among the dofetilide-treated compared with the placebo-treated patients (P =. 42). Torsade de pointes ventricular tachycardia developed in 2 patients (3%). In both patients, drug infusion was discontinued before the event because of prolongation of the QT interval.
Intravenous dofetilide is effective in acute termination of AF and AFL of medium duration, with a particularly high efficacy rate in AFL. A small but serious risk of proarrhythmia must be anticipated.</abstract><cop>United States</cop><pmid>10347332</pmid></addata></record> |
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| subjects | Aged Anti-Arrhythmia Agents - administration & dosage Anti-Arrhythmia Agents - adverse effects Anti-Arrhythmia Agents - pharmacokinetics Atrial Fibrillation - blood Atrial Fibrillation - drug therapy Atrial Fibrillation - physiopathology Atrial Flutter - blood Atrial Flutter - drug therapy Atrial Flutter - physiopathology Denmark Double-Blind Method Female Hemodynamics - drug effects Humans Infusions, Intravenous Male Middle Aged Phenethylamines - administration & dosage Phenethylamines - adverse effects Phenethylamines - pharmacokinetics Placebos Potassium Channel Blockers Prospective Studies Safety Sulfonamides - administration & dosage Sulfonamides - adverse effects Sulfonamides - pharmacokinetics Time Factors |
| title | Efficacy and safety of intravenously administered dofetilide in acute termination of atrial fibrillation and flutter: a multicenter, randomized, double-blind, placebo-controlled trial. Danish Dofetilide in Atrial Fibrillation and Flutter Study Group |
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