The study of antiarrhythmic medications in infancy (SAMIS): a multicenter, randomized controlled trial comparing the efficacy and safety of digoxin versus propranolol for prophylaxis of supraventricular tachycardia in infants.
Identifieur interne : 000A16 ( PubMed/Corpus ); précédent : 000A15; suivant : 000A17The study of antiarrhythmic medications in infancy (SAMIS): a multicenter, randomized controlled trial comparing the efficacy and safety of digoxin versus propranolol for prophylaxis of supraventricular tachycardia in infants.
Auteurs : Shubhayan Sanatani ; James E. Potts ; John H. Reed ; J Philip Saul ; Elizabeth A. Stephenson ; Karen A. Gibbs ; Charles C. Anderson ; Andrew S. Mackie ; Pamela S. Ro ; Svjetlana Tisma-Dupanovic ; Ronald J. Kanter ; Anjan S. Batra ; Anne Fournier ; Andrew D. Blaufox ; Harinder R. Singh ; Bertrand A. Ross ; Kenny K. Wong ; Yaniv Bar-Cohen ; Brian W. Mccrindle ; Susan P. EtheridgeSource :
- Circulation. Arrhythmia and electrophysiology [ 1941-3084 ] ; 2012.
English descriptors
- KwdEn :
- Anti-Arrhythmia Agents (therapeutic use), Canada, Chi-Square Distribution, Digoxin (therapeutic use), Double-Blind Method, Female, Humans, Infant, Infant, Newborn, Male, Proportional Hazards Models, Propranolol (therapeutic use), Recurrence, Tachycardia, Supraventricular (prevention & control), Treatment Outcome, United States.
- MESH :
- chemical , therapeutic use : Anti-Arrhythmia Agents, Digoxin, Propranolol.
- geographic : Canada, United States.
- prevention & control : Tachycardia, Supraventricular.
- Chi-Square Distribution, Double-Blind Method, Female, Humans, Infant, Infant, Newborn, Male, Proportional Hazards Models, Recurrence, Treatment Outcome.
Abstract
Supraventricular tachycardia (SVT) is one of the most common conditions requiring emergent cardiac care in children, yet its management has never been subjected to a randomized controlled clinical trial. The purpose of this study was to compare the efficacy and safety of the 2 most commonly used medications for antiarrhythmic prophylaxis of SVT in infants: digoxin and propranolol.
DOI: 10.1161/CIRCEP.112.972620
PubMed: 22962431
Links to Exploration step
pubmed:22962431Le document en format XML
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Reed</name></author><author><name sortKey="Saul, J Philip" sort="Saul, J Philip" uniqKey="Saul J" first="J Philip" last="Saul">J Philip Saul</name></author><author><name sortKey="Stephenson, Elizabeth A" sort="Stephenson, Elizabeth A" uniqKey="Stephenson E" first="Elizabeth A" last="Stephenson">Elizabeth A. Stephenson</name></author><author><name sortKey="Gibbs, Karen A" sort="Gibbs, Karen A" uniqKey="Gibbs K" first="Karen A" last="Gibbs">Karen A. Gibbs</name></author><author><name sortKey="Anderson, Charles C" sort="Anderson, Charles C" uniqKey="Anderson C" first="Charles C" last="Anderson">Charles C. Anderson</name></author><author><name sortKey="Mackie, Andrew S" sort="Mackie, Andrew S" uniqKey="Mackie A" first="Andrew S" last="Mackie">Andrew S. Mackie</name></author><author><name sortKey="Ro, Pamela S" sort="Ro, Pamela S" uniqKey="Ro P" first="Pamela S" last="Ro">Pamela S. Ro</name></author><author><name sortKey="Tisma Dupanovic, Svjetlana" sort="Tisma Dupanovic, Svjetlana" uniqKey="Tisma Dupanovic S" first="Svjetlana" last="Tisma-Dupanovic">Svjetlana Tisma-Dupanovic</name></author><author><name sortKey="Kanter, Ronald J" sort="Kanter, Ronald J" uniqKey="Kanter R" first="Ronald J" last="Kanter">Ronald J. Kanter</name></author><author><name sortKey="Batra, Anjan S" sort="Batra, Anjan S" uniqKey="Batra A" first="Anjan S" last="Batra">Anjan S. Batra</name></author><author><name sortKey="Fournier, Anne" sort="Fournier, Anne" uniqKey="Fournier A" first="Anne" last="Fournier">Anne Fournier</name></author><author><name sortKey="Blaufox, Andrew D" sort="Blaufox, Andrew D" uniqKey="Blaufox A" first="Andrew D" last="Blaufox">Andrew D. Blaufox</name></author><author><name sortKey="Singh, Harinder R" sort="Singh, Harinder R" uniqKey="Singh H" first="Harinder R" last="Singh">Harinder R. Singh</name></author><author><name sortKey="Ross, Bertrand A" sort="Ross, Bertrand A" uniqKey="Ross B" first="Bertrand A" last="Ross">Bertrand A. Ross</name></author><author><name sortKey="Wong, Kenny K" sort="Wong, Kenny K" uniqKey="Wong K" first="Kenny K" last="Wong">Kenny K. Wong</name></author><author><name sortKey="Bar Cohen, Yaniv" sort="Bar Cohen, Yaniv" uniqKey="Bar Cohen Y" first="Yaniv" last="Bar-Cohen">Yaniv Bar-Cohen</name></author><author><name sortKey="Mccrindle, Brian W" sort="Mccrindle, Brian W" uniqKey="Mccrindle B" first="Brian W" last="Mccrindle">Brian W. Mccrindle</name></author><author><name sortKey="Etheridge, Susan P" sort="Etheridge, Susan P" uniqKey="Etheridge S" first="Susan P" last="Etheridge">Susan P. Etheridge</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2012">2012</date><idno type="RBID">pubmed:22962431</idno><idno type="pmid">22962431</idno><idno type="doi">10.1161/CIRCEP.112.972620</idno><idno type="wicri:Area/PubMed/Corpus">000A16</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000A16</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">The study of antiarrhythmic medications in infancy (SAMIS): a multicenter, randomized controlled trial comparing the efficacy and safety of digoxin versus propranolol for prophylaxis of supraventricular tachycardia in infants.</title><author><name sortKey="Sanatani, Shubhayan" sort="Sanatani, Shubhayan" uniqKey="Sanatani S" first="Shubhayan" last="Sanatani">Shubhayan Sanatani</name><affiliation><nlm:affiliation>Division of Pediatric Cardiology, British Columbia Children's Hospital, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada. ssanatani@cw.bc.ca</nlm:affiliation></affiliation></author><author><name sortKey="Potts, James E" sort="Potts, James E" uniqKey="Potts J" first="James E" last="Potts">James E. Potts</name></author><author><name sortKey="Reed, John H" sort="Reed, John H" uniqKey="Reed J" first="John H" last="Reed">John H. Reed</name></author><author><name sortKey="Saul, J Philip" sort="Saul, J Philip" uniqKey="Saul J" first="J Philip" last="Saul">J Philip Saul</name></author><author><name sortKey="Stephenson, Elizabeth A" sort="Stephenson, Elizabeth A" uniqKey="Stephenson E" first="Elizabeth A" last="Stephenson">Elizabeth A. Stephenson</name></author><author><name sortKey="Gibbs, Karen A" sort="Gibbs, Karen A" uniqKey="Gibbs K" first="Karen A" last="Gibbs">Karen A. Gibbs</name></author><author><name sortKey="Anderson, Charles C" sort="Anderson, Charles C" uniqKey="Anderson C" first="Charles C" last="Anderson">Charles C. Anderson</name></author><author><name sortKey="Mackie, Andrew S" sort="Mackie, Andrew S" uniqKey="Mackie A" first="Andrew S" last="Mackie">Andrew S. Mackie</name></author><author><name sortKey="Ro, Pamela S" sort="Ro, Pamela S" uniqKey="Ro P" first="Pamela S" last="Ro">Pamela S. Ro</name></author><author><name sortKey="Tisma Dupanovic, Svjetlana" sort="Tisma Dupanovic, Svjetlana" uniqKey="Tisma Dupanovic S" first="Svjetlana" last="Tisma-Dupanovic">Svjetlana Tisma-Dupanovic</name></author><author><name sortKey="Kanter, Ronald J" sort="Kanter, Ronald J" uniqKey="Kanter R" first="Ronald J" last="Kanter">Ronald J. Kanter</name></author><author><name sortKey="Batra, Anjan S" sort="Batra, Anjan S" uniqKey="Batra A" first="Anjan S" last="Batra">Anjan S. Batra</name></author><author><name sortKey="Fournier, Anne" sort="Fournier, Anne" uniqKey="Fournier A" first="Anne" last="Fournier">Anne Fournier</name></author><author><name sortKey="Blaufox, Andrew D" sort="Blaufox, Andrew D" uniqKey="Blaufox A" first="Andrew D" last="Blaufox">Andrew D. Blaufox</name></author><author><name sortKey="Singh, Harinder R" sort="Singh, Harinder R" uniqKey="Singh H" first="Harinder R" last="Singh">Harinder R. Singh</name></author><author><name sortKey="Ross, Bertrand A" sort="Ross, Bertrand A" uniqKey="Ross B" first="Bertrand A" last="Ross">Bertrand A. Ross</name></author><author><name sortKey="Wong, Kenny K" sort="Wong, Kenny K" uniqKey="Wong K" first="Kenny K" last="Wong">Kenny K. Wong</name></author><author><name sortKey="Bar Cohen, Yaniv" sort="Bar Cohen, Yaniv" uniqKey="Bar Cohen Y" first="Yaniv" last="Bar-Cohen">Yaniv Bar-Cohen</name></author><author><name sortKey="Mccrindle, Brian W" sort="Mccrindle, Brian W" uniqKey="Mccrindle B" first="Brian W" last="Mccrindle">Brian W. Mccrindle</name></author><author><name sortKey="Etheridge, Susan P" sort="Etheridge, Susan P" uniqKey="Etheridge S" first="Susan P" last="Etheridge">Susan P. Etheridge</name></author></analytic><series><title level="j">Circulation. Arrhythmia and electrophysiology</title><idno type="eISSN">1941-3084</idno><imprint><date when="2012" type="published">2012</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Anti-Arrhythmia Agents (therapeutic use)</term><term>Canada</term><term>Chi-Square Distribution</term><term>Digoxin (therapeutic use)</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Infant</term><term>Infant, Newborn</term><term>Male</term><term>Proportional Hazards Models</term><term>Propranolol (therapeutic use)</term><term>Recurrence</term><term>Tachycardia, Supraventricular (prevention & control)</term><term>Treatment Outcome</term><term>United States</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Anti-Arrhythmia Agents</term><term>Digoxin</term><term>Propranolol</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Canada</term><term>United States</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Tachycardia, Supraventricular</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Chi-Square Distribution</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Infant</term><term>Infant, Newborn</term><term>Male</term><term>Proportional Hazards Models</term><term>Recurrence</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Supraventricular tachycardia (SVT) is one of the most common conditions requiring emergent cardiac care in children, yet its management has never been subjected to a randomized controlled clinical trial. The purpose of this study was to compare the efficacy and safety of the 2 most commonly used medications for antiarrhythmic prophylaxis of SVT in infants: digoxin and propranolol.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">22962431</PMID><DateCreated><Year>2012</Year><Month>10</Month><Day>17</Day></DateCreated><DateCompleted><Year>2013</Year><Month>01</Month><Day>04</Day></DateCompleted><DateRevised><Year>2013</Year><Month>11</Month><Day>21</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1941-3084</ISSN><JournalIssue CitedMedium="Internet"><Volume>5</Volume><Issue>5</Issue><PubDate><Year>2012</Year><Month>Oct</Month></PubDate></JournalIssue><Title>Circulation. Arrhythmia and electrophysiology</Title><ISOAbbreviation>Circ Arrhythm Electrophysiol</ISOAbbreviation></Journal><ArticleTitle>The study of antiarrhythmic medications in infancy (SAMIS): a multicenter, randomized controlled trial comparing the efficacy and safety of digoxin versus propranolol for prophylaxis of supraventricular tachycardia in infants.</ArticleTitle><Pagination><MedlinePgn>984-91</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1161/CIRCEP.112.972620</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Supraventricular tachycardia (SVT) is one of the most common conditions requiring emergent cardiac care in children, yet its management has never been subjected to a randomized controlled clinical trial. The purpose of this study was to compare the efficacy and safety of the 2 most commonly used medications for antiarrhythmic prophylaxis of SVT in infants: digoxin and propranolol.</AbstractText><AbstractText Label="METHODS AND RESULTS" NlmCategory="RESULTS">This was a randomized, double-blind, multicenter study of infants <4 months with SVT (atrioventricular reciprocating tachycardia or atrioventricular nodal reentrant tachycardia), excluding Wolff-Parkinson-White, comparing digoxin with propranolol. The primary end point was recurrence of SVT requiring medical intervention. Time to recurrence and adverse events were secondary outcomes. Sixty-one patients completed the study, 27 randomized to digoxin and 34 to propranolol. SVT recurred in 19% of patients on digoxin and 31% of patients on propranolol (P=0.25). No first recurrence occurred after 110 days of treatment. The 6-month recurrence-free status was 79% for patients on digoxin and 67% for patients on propranolol (P=0.34), and there were no first recurrences in either group between 6 and 12 months. There were no deaths and no serious adverse events related to study medication.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">There was no difference in SVT recurrence in infants treated with digoxin versus propranolol. The current standard practice may be treating infants longer than required and indicates the need for a placebo-controlled trial. Clinical Trial Registration Information- http://clinicaltrials.gov; NCT-00390546.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Sanatani</LastName><ForeName>Shubhayan</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Division of Pediatric Cardiology, British Columbia Children's Hospital, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada. ssanatani@cw.bc.ca</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Potts</LastName><ForeName>James E</ForeName><Initials>JE</Initials></Author><Author ValidYN="Y"><LastName>Reed</LastName><ForeName>John H</ForeName><Initials>JH</Initials></Author><Author ValidYN="Y"><LastName>Saul</LastName><ForeName>J Philip</ForeName><Initials>JP</Initials></Author><Author ValidYN="Y"><LastName>Stephenson</LastName><ForeName>Elizabeth A</ForeName><Initials>EA</Initials></Author><Author ValidYN="Y"><LastName>Gibbs</LastName><ForeName>Karen A</ForeName><Initials>KA</Initials></Author><Author ValidYN="Y"><LastName>Anderson</LastName><ForeName>Charles C</ForeName><Initials>CC</Initials></Author><Author ValidYN="Y"><LastName>Mackie</LastName><ForeName>Andrew S</ForeName><Initials>AS</Initials></Author><Author ValidYN="Y"><LastName>Ro</LastName><ForeName>Pamela S</ForeName><Initials>PS</Initials></Author><Author ValidYN="Y"><LastName>Tisma-Dupanovic</LastName><ForeName>Svjetlana</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Kanter</LastName><ForeName>Ronald J</ForeName><Initials>RJ</Initials></Author><Author ValidYN="Y"><LastName>Batra</LastName><ForeName>Anjan S</ForeName><Initials>AS</Initials></Author><Author ValidYN="Y"><LastName>Fournier</LastName><ForeName>Anne</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Blaufox</LastName><ForeName>Andrew D</ForeName><Initials>AD</Initials></Author><Author ValidYN="Y"><LastName>Singh</LastName><ForeName>Harinder R</ForeName><Initials>HR</Initials></Author><Author ValidYN="Y"><LastName>Ross</LastName><ForeName>Bertrand A</ForeName><Initials>BA</Initials></Author><Author ValidYN="Y"><LastName>Wong</LastName><ForeName>Kenny K</ForeName><Initials>KK</Initials></Author><Author ValidYN="Y"><LastName>Bar-Cohen</LastName><ForeName>Yaniv</ForeName><Initials>Y</Initials></Author><Author ValidYN="Y"><LastName>McCrindle</LastName><ForeName>Brian W</ForeName><Initials>BW</Initials></Author><Author ValidYN="Y"><LastName>Etheridge</LastName><ForeName>Susan P</ForeName><Initials>SP</Initials></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT00390546</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D003160">Comparative Study</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2012</Year><Month>09</Month><Day>08</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Circ Arrhythm Electrophysiol</MedlineTA><NlmUniqueID>101474365</NlmUniqueID><ISSNLinking>1941-3084</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000889">Anti-Arrhythmia Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>73K4184T59</RegistryNumber><NameOfSubstance UI="D004077">Digoxin</NameOfSubstance></Chemical><Chemical><RegistryNumber>9Y8NXQ24VQ</RegistryNumber><NameOfSubstance UI="D011433">Propranolol</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="CommentIn"><RefSource>Circ Arrhythm Electrophysiol. 2012 Oct;5(5):882-3</RefSource><PMID Version="1">23074324</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000889" MajorTopicYN="N">Anti-Arrhythmia Agents</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002170" MajorTopicYN="N" Type="Geographic">Canada</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016009" MajorTopicYN="N">Chi-Square Distribution</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004077" MajorTopicYN="N">Digoxin</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007223" MajorTopicYN="N">Infant</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007231" MajorTopicYN="N">Infant, Newborn</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016016" MajorTopicYN="N">Proportional Hazards Models</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011433" MajorTopicYN="N">Propranolol</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012008" MajorTopicYN="N">Recurrence</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013617" MajorTopicYN="N">Tachycardia, Supraventricular</DescriptorName><QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014481" MajorTopicYN="N" Type="Geographic">United States</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2012</Year><Month>9</Month><Day>11</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2012</Year><Month>9</Month><Day>11</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2013</Year><Month>1</Month><Day>5</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">22962431</ArticleId><ArticleId IdType="pii">CIRCEP.112.972620</ArticleId><ArticleId 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