title: 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.
abstract: 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.
  
  
  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.
  
  
  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.affiliation: Division of Pediatric Cardiology, British Columbia Children's Hospital, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada. ssanatani@cw.bc.ca
authors.forename: Shubhayan
authors.initials: S
authors.lastname: Sanatani
authors.forename: James E
authors.initials: JE
authors.lastname: Potts
authors.forename: John H
authors.initials: JH
authors.lastname: Reed
authors.forename: J Philip
authors.initials: JP
authors.lastname: Saul
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Stephenson
authors.forename: Karen A
authors.initials: KA
authors.lastname: Gibbs
authors.forename: Charles C
authors.initials: CC
authors.lastname: Anderson
authors.forename: Andrew S
authors.initials: AS
authors.lastname: Mackie
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Ro
authors.forename: Svjetlana
authors.initials: S
authors.lastname: Tisma-Dupanovic
authors.forename: Ronald J
authors.initials: RJ
authors.lastname: Kanter
authors.forename: Anjan S
authors.initials: AS
authors.lastname: Batra
authors.forename: Anne
authors.initials: A
authors.lastname: Fournier
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Blaufox
authors.forename: Harinder R
authors.initials: HR
authors.lastname: Singh
authors.forename: Bertrand A
authors.initials: BA
authors.lastname: Ross
authors.forename: Kenny K
authors.initials: KK
authors.lastname: Wong
authors.forename: Yaniv
authors.initials: Y
authors.lastname: Bar-Cohen
authors.forename: Brian W
authors.initials: BW
authors.lastname: McCrindle
authors.forename: Susan P
authors.initials: SP
authors.lastname: Etheridge
mesh_terms: D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use*; D002170:Canada; D016009:Chi-Square Distribution; D004077:Digoxin / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D016016:Proportional Hazards Models; D011433:Propranolol / Q000627:therapeutic use*; D012008:Recurrence; D013617:Tachycardia, Supraventricular / Q000517:prevention & control*; D016896:Treatment Outcome; D014481:United States
chemical_list: D000889:Anti-Arrhythmia Agents; D004077:Digoxin; D011433:Propranolol