Effects of cisapride on QTc interval in neonates
- aCentre Hospitalier Universitaire, 10 Bd Maréchal de Lattre de Tassigny, 21034 Dijon, Cedex, France Service de Pédiatrie 2, Hôpital d’Enfants, bCentre Régional de Pharmacovigilance,
- Dr J B Gouyon.
- Accepted 11 June 1997
Abstract
AIM Prospective survey of the effects of cisapride on QTc interval in neonates given cisapride.
METHODS QTc interval was determined just before and 2.9 (0.9) days after outset of the treatment in 49 neonates treated with cisapride between 1 August 1995 and 29 February 1996.
RESULTS Cisapride significantly increased QTc interval (p = 0.0001), and this was higher when birthweight or gestational age were lower. The prolongation of QTc interval above the arbitrary value of 0.450 (n = 7) was clinically asymptomatic and was significantly more common in the infants born with a gestational age ≤ 33 weeks (n = 6).
CONCLUSION The findings indicate that cisapride accumulates in less mature neonates. Further pharmacokinetic studies are needed.
