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Oral propranolol for retinopathy of prematurity: risks, safety concerns, and perspectives.

AbstractOBJECTIVE:
To evaluate safety and efficacy of oral propranolol administration in preterm newborns affected by an early phase of retinopathy of prematurity (ROP).
STUDY DESIGN:
Fifty-two preterm newborns with Stage 2 ROP were randomized to receive oral propranolol (0.25 or 0.5 mg/kg/6 hours) added to standard treatment or standard treatment alone. To evaluate safety of the treatment, hemodynamic and respiratory variables were continuously monitored, and blood samples were collected weekly to check for renal, liver, and metabolic balance. To evaluate efficacy of the treatment, the progression of the disease (number of laser treatments, number of bevacizumab treatments, and incidence of retinal detachment) was evaluated by serial ophthalmologic examinations, and plasma soluble E-selectin levels were measured weekly.
RESULTS:
Newborns treated with propranolol showed less progression to Stage 3 (risk ratio 0.52; 95% CI 0.47-0.58, relative reduction of risk 48%) or Stage 3 plus (relative risk 0.42 95% CI 0.31-0.58, relative reduction of risk 58%). The infants required fewer laser treatments and less need for rescue treatment with intravitreal bevacizumab (relative risk 0.48; 95% CI 0.29-0.79, relative reduction of risk 52 %), a 100% relative reduction of risk for progression to Stage 4. They also had significantly lower plasma soluble E-selectin levels. However, 5 of the 26 newborns treated with propranolol had serious adverse effects (hypotension, bradycardia), in conjunction with episodes of sepsis, anesthesia induction, or tracheal stimulation.
CONCLUSION:
This pilot study suggests that the administration of oral propranolol is effective in counteracting the progression of ROP but that safety is a concern.
AuthorsLuca Filippi, Giacomo Cavallaro, Paola Bagnoli, Massimo Dal Monte, Patrizio Fiorini, Gianpaolo Donzelli, Francesca Tinelli, Gabriella Araimo, Gloria Cristofori, Giancarlo la Marca, Maria Luisa Della Bona, Agostino La Torre, Pina Fortunato, Sandra Furlanetto, Silvia Osnaghi, Fabio Mosca
JournalThe Journal of pediatrics (J Pediatr) Vol. 163 Issue 6 Pg. 1570-1577.e6 (Dec 2013) ISSN: 1097-6833 [Electronic] United States
PMID24054431 (Publication Type: Journal Article, Randomized Controlled Trial)
CopyrightCopyright © 2013 Mosby, Inc. All rights reserved.
Chemical References
  • Adrenergic beta-Antagonists
  • Propranolol
Topics
  • Adrenergic beta-Antagonists (adverse effects, therapeutic use)
  • Female
  • Humans
  • Infant, Premature
  • Male
  • Pilot Projects
  • Propranolol (adverse effects, therapeutic use)
  • Retinopathy of Prematurity (drug therapy)
  • Risk Factors
  • Single-Blind Method

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