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Oral Propranolol: A New Treatment for Infants with Retinopathy of Prematurity?
Christoph Bührer1, Dirk Bassler
1Department of Neonatology, Charité University Medical Center, Berlin, Germany.
Insights
Oral propranolol may reduce the need for interventions in retinopathy of prematurity (ROP) for preterm infants. Further large studies are needed to confirm the benefit-risk ratio of this treatment.
Area of Science:
- Neonatal medicine
- Ophthalmology
- Pharmacology
Background:
- Infantile hemangiomas are treated with oral propranolol, a drug now available as a pediatric solution.
- Very preterm infants with infantile hemangiomas are also at risk for retinopathy of prematurity (ROP).
- Both infantile hemangiomas and ROP share a similar disease progression timeline.
Purpose of the Study:
- To review clinical studies on oral propranolol use in preterm infants diagnosed with ROP.
Main Methods:
- Two pilot randomized controlled trials were analyzed.
- Data from infants receiving oral propranolol versus control groups were compared.
Main Results:
- A trend towards reduced ROP intervention was observed in infants treated with oral propranolol (17%) compared to controls (39%).
- The reduction in ROP interventions was not statistically significant.
- Ongoing trials are investigating early preventive propranolol and propranolol eye drops for ROP.
Conclusions:
- Larger interventional studies are necessary to establish the clinical benefit-risk balance of oral propranolol for preventing vision-threatening ROP in very preterm infants.
Introduction:
Oral propranolol has improved the treatment of infantile hemangiomas, and a pediatric oral solution of propranolol has recently been licensed in the USA and Europe. In very preterm infants, infantile hemangiomas are associated with the occurrence of retinopathy of prematurity (ROP), and both diseases share a peculiar time course, featuring a lag phase after birth followed by rapid growth and then gradual regression.
Objectives:
To identify clinical studies evaluating the use of oral propranolol in preterm infants with ROP.
Results:
Two small bicentric, pilot, randomized controlled trials found a nonsignificant reduction of ROP requiring intervention by laser treatment or bevacizumab injection of similar magnitude. Together, 6 of 35 (17%) infants who had been receiving oral propranolol underwent ROP intervention, as opposed to 14 of 36 (39%) controls (relative risk 0.42, 95% CI: 0.15-1.16). Randomized controlled trials are ongoing that investigate early preventive oral propranolol starting at 1 week of age and propranolol eye drops in preterm infants with stage 2 ROP.
Conclusion:
Further, large interventional studies are required to determine the clinical benefit-risk ratio of oral propranolol to prevent vision-threatening ROP in very preterm infants.
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