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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.
- Source :
-
Circulation. Arrhythmia and electrophysiology [Circ Arrhythm Electrophysiol] 2012 Oct; Vol. 5 (5), pp. 984-91. Date of Electronic Publication: 2012 Sep 08. - Publication Year :
- 2012
-
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.<br />Methods and 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.<br />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.
- Subjects :
- Canada
Chi-Square Distribution
Double-Blind Method
Female
Humans
Infant
Infant, Newborn
Male
Proportional Hazards Models
Recurrence
Treatment Outcome
United States
Anti-Arrhythmia Agents therapeutic use
Digoxin therapeutic use
Propranolol therapeutic use
Tachycardia, Supraventricular prevention & control
Subjects
Details
- Language :
- English
- ISSN :
- 1941-3084
- Volume :
- 5
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Circulation. Arrhythmia and electrophysiology
- Publication Type :
- Academic Journal
- Accession number :
- 22962431
- Full Text :
- https://doi.org/10.1161/CIRCEP.112.972620