Oral Propranolol for Retinopathy of Prematurity: Risks, Safety Concerns, and Perspectives - 23/11/13
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Abstract |
Objective |
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.
Le texte complet de cet article est disponible en PDF.Keyword : β-AR, GA, OIR, ROP, VEGF
Plan
The authors declare no conflicts of interest. |
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Registered with ClinicalTrials.gov (NCT01079715), Current Controlled Trials (ISRCTN18523491), and European Union Drug Regulating Authorities Clinical Trials (2010-018737-21). |
Vol 163 - N° 6
P. 1570 - décembre 2013 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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