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The Study of Antiarrhythmic Medications in Infancy (SAMIS): A Multi-Center, Randomized Controlled Trial Comparing the Efficacy and Safety of Digoxin Versus Propranolol for Prophylaxis of Supraventricular Tachycardia in Infants.
MedLine Citation:
PMID:  22962431     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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. METHODS AND RESULTS: -This was a randomized, double-blind, multi-center study of infants <4 months with SVT (AVRT or AVNRT), excluding Wolff-Parkinson-White, comparing digoxin to 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 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. 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.
Authors:
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 Etheridge
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-9-8
Journal Detail:
Title:  Circulation. Arrhythmia and electrophysiology     Volume:  -     ISSN:  1941-3084     ISO Abbreviation:  Circ Arrhythm Electrophysiol     Publication Date:  2012 Sep 
Date Detail:
Created Date:  2012-9-10     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101474365     Medline TA:  Circ Arrhythm Electrophysiol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
1 British Columbia Children's Hospital & University of British Columbia, Vancouver, BC, Canada;
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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