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.
Circ Arrhythm Electrophysiol
; 5(5): 984-91, 2012 Oct.
Article
en En
| MEDLINE
| ID: mdl-22962431
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. METHODS ANDRESULTS:
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.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Propranolol
/
Taquicardia Supraventricular
/
Digoxina
/
Antiarrítmicos
Tipo de estudio:
Clinical_trials
Límite:
Female
/
Humans
/
Infant
/
Male
/
Newborn
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Circ Arrhythm Electrophysiol
Asunto de la revista:
ANGIOLOGIA
/
CARDIOLOGIA
Año:
2012
Tipo del documento:
Article
País de afiliación:
Canadá