Efficacy and safety of dofetilide in the prevention of symptomatic episodes of paroxysmal supraventricular tachycardia: A 6-month double-blind comparison with propafenone and placebo

Background Existing drug therapies for paroxysmal supraventricular tachycardia (PSVT) have potentially serious adverse effects. Dofetilide, a pure class III antiarrhythmic agent, may offer an effective and safe alternative for treating PSVT. This study compared the efficacy and safety of dofetilide...

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Veröffentlicht in:The American heart journal 2001-07, Vol.142 (1), p.93-98
Hauptverfasser: Tendera, Michal, Wnuk-Wojnar, Anna Maria, Kulakowski, Piotr, Malolepszy, Józef, Kozlowski, J.W., Krzeminska-Pakula, M., Szechinski, Jacek, Droszcz, Waclaw, Kawecka-Jaszcz, Kalina, Swiatecka, Grazyna, Ruzyllo, Witold, Graff, Ole
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container_issue 1
container_start_page 93
container_title The American heart journal
container_volume 142
creator Tendera, Michal
Wnuk-Wojnar, Anna Maria
Kulakowski, Piotr
Malolepszy, Józef
Kozlowski, J.W.
Krzeminska-Pakula, M.
Szechinski, Jacek
Droszcz, Waclaw
Kawecka-Jaszcz, Kalina
Swiatecka, Grazyna
Ruzyllo, Witold
Graff, Ole
description Background Existing drug therapies for paroxysmal supraventricular tachycardia (PSVT) have potentially serious adverse effects. Dofetilide, a pure class III antiarrhythmic agent, may offer an effective and safe alternative for treating PSVT. This study compared the efficacy and safety of dofetilide with that of propafenone and placebo in the prevention of PSVT. Methods This multicenter, randomized, placebo-controlled, parallel-group study compared the effectiveness of oral dofetilide 500 μg given twice daily with that of propafenone 150 mg given 3 times a day and placebo in preventing the recurrence of PSVT in 122 symptomatic patients. Episodes of PSVT were documented by symptom diaries and Hertcard (Hertford Medical, Hertfordshire, UK) event recorders. Results After 6 months of treatment, patients taking dofetilide, propafenone, and placebo had a 50%, 54%, and 6% probability, respectively, of remaining free of episodes of PSVT (P
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Dofetilide, a pure class III antiarrhythmic agent, may offer an effective and safe alternative for treating PSVT. This study compared the efficacy and safety of dofetilide with that of propafenone and placebo in the prevention of PSVT. Methods This multicenter, randomized, placebo-controlled, parallel-group study compared the effectiveness of oral dofetilide 500 μg given twice daily with that of propafenone 150 mg given 3 times a day and placebo in preventing the recurrence of PSVT in 122 symptomatic patients. Episodes of PSVT were documented by symptom diaries and Hertcard (Hertford Medical, Hertfordshire, UK) event recorders. Results After 6 months of treatment, patients taking dofetilide, propafenone, and placebo had a 50%, 54%, and 6% probability, respectively, of remaining free of episodes of PSVT (P &lt;.001 for both dofetilide and propafenone vs placebo). Both dofetilide and propafenone also decreased the frequency of episodes of PSVT; the median numbers of episodes in the dofetilide- and propafenone-treated groups were 1 and 0.5, respectively, compared with 5 in the placebo-treated group. Dofetilide was well tolerated; no proarrhythmia occurred. Three patients taking propafenone had serious treatment-related adverse effects that required drug discontinuation. Conclusions Dofetilide and propafenone were equally effective in preventing the recurrence of or decreasing the frequency of PSVT. 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Drug treatments ; Phenethylamines - therapeutic use ; Propafenone - therapeutic use ; Proportional Hazards Models ; Sulfonamides - therapeutic use ; Survival Analysis ; Tachycardia, Supraventricular - prevention &amp; control ; Treatment Outcome</subject><ispartof>The American heart journal, 2001-07, Vol.142 (1), p.93-98</ispartof><rights>2001 Mosby, Inc.</rights><rights>2001 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c304t-b7798def8f93074eb8fa0a83e463a48cce44d626f9e27197ba4b79eee2b68c5d3</citedby><cites>FETCH-LOGICAL-c304t-b7798def8f93074eb8fa0a83e463a48cce44d626f9e27197ba4b79eee2b68c5d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0002870301998370$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=1074533$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11431663$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tendera, Michal</creatorcontrib><creatorcontrib>Wnuk-Wojnar, Anna Maria</creatorcontrib><creatorcontrib>Kulakowski, Piotr</creatorcontrib><creatorcontrib>Malolepszy, Józef</creatorcontrib><creatorcontrib>Kozlowski, J.W.</creatorcontrib><creatorcontrib>Krzeminska-Pakula, M.</creatorcontrib><creatorcontrib>Szechinski, Jacek</creatorcontrib><creatorcontrib>Droszcz, Waclaw</creatorcontrib><creatorcontrib>Kawecka-Jaszcz, Kalina</creatorcontrib><creatorcontrib>Swiatecka, Grazyna</creatorcontrib><creatorcontrib>Ruzyllo, Witold</creatorcontrib><creatorcontrib>Graff, Ole</creatorcontrib><title>Efficacy and safety of dofetilide in the prevention of symptomatic episodes of paroxysmal supraventricular tachycardia: A 6-month double-blind comparison with propafenone and placebo</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>Background Existing drug therapies for paroxysmal supraventricular tachycardia (PSVT) have potentially serious adverse effects. Dofetilide, a pure class III antiarrhythmic agent, may offer an effective and safe alternative for treating PSVT. This study compared the efficacy and safety of dofetilide with that of propafenone and placebo in the prevention of PSVT. Methods This multicenter, randomized, placebo-controlled, parallel-group study compared the effectiveness of oral dofetilide 500 μg given twice daily with that of propafenone 150 mg given 3 times a day and placebo in preventing the recurrence of PSVT in 122 symptomatic patients. Episodes of PSVT were documented by symptom diaries and Hertcard (Hertford Medical, Hertfordshire, UK) event recorders. Results After 6 months of treatment, patients taking dofetilide, propafenone, and placebo had a 50%, 54%, and 6% probability, respectively, of remaining free of episodes of PSVT (P &lt;.001 for both dofetilide and propafenone vs placebo). Both dofetilide and propafenone also decreased the frequency of episodes of PSVT; the median numbers of episodes in the dofetilide- and propafenone-treated groups were 1 and 0.5, respectively, compared with 5 in the placebo-treated group. Dofetilide was well tolerated; no proarrhythmia occurred. Three patients taking propafenone had serious treatment-related adverse effects that required drug discontinuation. Conclusions Dofetilide and propafenone were equally effective in preventing the recurrence of or decreasing the frequency of PSVT. 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Drug treatments</subject><subject>Phenethylamines - therapeutic use</subject><subject>Propafenone - therapeutic use</subject><subject>Proportional Hazards Models</subject><subject>Sulfonamides - therapeutic use</subject><subject>Survival Analysis</subject><subject>Tachycardia, Supraventricular - prevention &amp; control</subject><subject>Treatment Outcome</subject><issn>0002-8703</issn><issn>1097-6744</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2001</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kUFv1DAQhSMEokvhzA35gLhla8deO-FWVaUgVeICZ2tij7WuEjvYSSF_jN-H010JLpw89nzz_DSvqt4yumdUqqvx-LBvKGV7xg6Cd8-qHaOdqqUS4nm1o5Q2dasov6he5fxQrrJp5cvqgjHBmZR8V_2-dc4bMCuBYEkGh_NKoiM2lsoP3iLxgcxHJFPCRwyzj2Hr53Wc5jjC7A3ByedoMW_vE6T4a80jDCQvU4JtJHmzDJDIDOa4GkjWw0dyTWQ9xjAfy1dLP2DdD744MHEsEkUvkJ--NKcUp2IqxIBPDqcBDPbxdfXCwZDxzfm8rL5_uv1287m-_3r35eb6vjacirnulepai651HadKYN86oNByFJKDaI1BIaxspOuwUaxTPYhedYjY9LI1B8svqw8n3eLjx4J51qPPBocBAsYla0U7eWhpW8CrE2hSzDmh01PyI6RVM6q3qHSJSm9R6VNUZeLdWXrpR7R_-XM2BXh_BiAbGFyCYHz-R1eJA9-w7oRh2cOjx6Sz8RgMWp_QzNpG_18PfwBAb7TN</recordid><startdate>20010701</startdate><enddate>20010701</enddate><creator>Tendera, Michal</creator><creator>Wnuk-Wojnar, Anna Maria</creator><creator>Kulakowski, Piotr</creator><creator>Malolepszy, Józef</creator><creator>Kozlowski, J.W.</creator><creator>Krzeminska-Pakula, M.</creator><creator>Szechinski, Jacek</creator><creator>Droszcz, Waclaw</creator><creator>Kawecka-Jaszcz, Kalina</creator><creator>Swiatecka, Grazyna</creator><creator>Ruzyllo, Witold</creator><creator>Graff, Ole</creator><general>Mosby, Inc</general><general>Elsevier</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>7X8</scope></search><sort><creationdate>20010701</creationdate><title>Efficacy and safety of dofetilide in the prevention of symptomatic episodes of paroxysmal supraventricular tachycardia: A 6-month double-blind comparison with propafenone and placebo</title><author>Tendera, Michal ; Wnuk-Wojnar, Anna Maria ; Kulakowski, Piotr ; Malolepszy, Józef ; Kozlowski, J.W. ; Krzeminska-Pakula, M. ; Szechinski, Jacek ; Droszcz, Waclaw ; Kawecka-Jaszcz, Kalina ; Swiatecka, Grazyna ; Ruzyllo, Witold ; Graff, Ole</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c304t-b7798def8f93074eb8fa0a83e463a48cce44d626f9e27197ba4b79eee2b68c5d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2001</creationdate><topic>Administration, Oral</topic><topic>Aged</topic><topic>Anti-Arrhythmia Agents - therapeutic use</topic><topic>Antiarythmic agents</topic><topic>Biological and medical sciences</topic><topic>Cardiovascular system</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pharmacology. Drug treatments</topic><topic>Phenethylamines - therapeutic use</topic><topic>Propafenone - therapeutic use</topic><topic>Proportional Hazards Models</topic><topic>Sulfonamides - therapeutic use</topic><topic>Survival Analysis</topic><topic>Tachycardia, Supraventricular - prevention &amp; control</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tendera, Michal</creatorcontrib><creatorcontrib>Wnuk-Wojnar, Anna Maria</creatorcontrib><creatorcontrib>Kulakowski, Piotr</creatorcontrib><creatorcontrib>Malolepszy, Józef</creatorcontrib><creatorcontrib>Kozlowski, J.W.</creatorcontrib><creatorcontrib>Krzeminska-Pakula, M.</creatorcontrib><creatorcontrib>Szechinski, Jacek</creatorcontrib><creatorcontrib>Droszcz, Waclaw</creatorcontrib><creatorcontrib>Kawecka-Jaszcz, Kalina</creatorcontrib><creatorcontrib>Swiatecka, Grazyna</creatorcontrib><creatorcontrib>Ruzyllo, Witold</creatorcontrib><creatorcontrib>Graff, Ole</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>MEDLINE - Academic</collection><jtitle>The American heart journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tendera, Michal</au><au>Wnuk-Wojnar, Anna Maria</au><au>Kulakowski, Piotr</au><au>Malolepszy, Józef</au><au>Kozlowski, J.W.</au><au>Krzeminska-Pakula, M.</au><au>Szechinski, Jacek</au><au>Droszcz, Waclaw</au><au>Kawecka-Jaszcz, Kalina</au><au>Swiatecka, Grazyna</au><au>Ruzyllo, Witold</au><au>Graff, Ole</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of dofetilide in the prevention of symptomatic episodes of paroxysmal supraventricular tachycardia: A 6-month double-blind comparison with propafenone and placebo</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>2001-07-01</date><risdate>2001</risdate><volume>142</volume><issue>1</issue><spage>93</spage><epage>98</epage><pages>93-98</pages><issn>0002-8703</issn><eissn>1097-6744</eissn><coden>AHJOA2</coden><abstract>Background Existing drug therapies for paroxysmal supraventricular tachycardia (PSVT) have potentially serious adverse effects. Dofetilide, a pure class III antiarrhythmic agent, may offer an effective and safe alternative for treating PSVT. This study compared the efficacy and safety of dofetilide with that of propafenone and placebo in the prevention of PSVT. Methods This multicenter, randomized, placebo-controlled, parallel-group study compared the effectiveness of oral dofetilide 500 μg given twice daily with that of propafenone 150 mg given 3 times a day and placebo in preventing the recurrence of PSVT in 122 symptomatic patients. Episodes of PSVT were documented by symptom diaries and Hertcard (Hertford Medical, Hertfordshire, UK) event recorders. Results After 6 months of treatment, patients taking dofetilide, propafenone, and placebo had a 50%, 54%, and 6% probability, respectively, of remaining free of episodes of PSVT (P &lt;.001 for both dofetilide and propafenone vs placebo). Both dofetilide and propafenone also decreased the frequency of episodes of PSVT; the median numbers of episodes in the dofetilide- and propafenone-treated groups were 1 and 0.5, respectively, compared with 5 in the placebo-treated group. Dofetilide was well tolerated; no proarrhythmia occurred. Three patients taking propafenone had serious treatment-related adverse effects that required drug discontinuation. Conclusions Dofetilide and propafenone were equally effective in preventing the recurrence of or decreasing the frequency of PSVT. (Am Heart J 2001;142:93-8.)</abstract><cop>New York, NY</cop><pub>Mosby, Inc</pub><pmid>11431663</pmid><doi>10.1067/mhj.2001.115439</doi><tpages>6</tpages></addata></record>
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subjects Administration, Oral
Aged
Anti-Arrhythmia Agents - therapeutic use
Antiarythmic agents
Biological and medical sciences
Cardiovascular system
Double-Blind Method
Female
Humans
Male
Medical sciences
Middle Aged
Pharmacology. Drug treatments
Phenethylamines - therapeutic use
Propafenone - therapeutic use
Proportional Hazards Models
Sulfonamides - therapeutic use
Survival Analysis
Tachycardia, Supraventricular - prevention & control
Treatment Outcome
title Efficacy and safety of dofetilide in the prevention of symptomatic episodes of paroxysmal supraventricular tachycardia: A 6-month double-blind comparison with propafenone and placebo
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