Evidence summary
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Efficacy:
Prevention and treatment of retinopathy of prematurity in preterm infants: A
systematic review [4] found 3 RCTs (participants = 366), with all studies comparing oral propranolol with placebo or no treatment for prevention of ROP. Filippi et al 2013 [5] compared oral propranolol 1 to 2 mg/kg/day versus no treatment. Propranolol was administered until complete retinal vascularisation and for a maximum of 90 days.
Korkmaz et al 2017 [6] compared propranolol 2 mg/kg/day or placebo from 31 weeks’ PMA (duration not reported). Sanghvi et al 2017[7] compared oral propranolol 1mg/kg/day or placebo (calcium carbonate 1 mg/kg/day) from 7 days of life and continued until complete retinal vascularisation or 37 weeks’ PMA. No trials assessed beta-blockers in infants with established stage 2 or higher ROP with plus disease. Meta-analysis of 3 trials (n = 366) found oral beta-blockers reduced risk of requiring anti-VEGF agents (RR 0.32, 95% CI 0.12 to 0.86; I² = 0%; typical risk difference (RD) −0.06, 95% CI −0.10 to −0.01; I² = 75%; NNTB 18, 95% CI 14 to 84) and laser therapy (RR 0.54, 95% CI 0.32 to 0.89; typical RD −0.09, 95% CI −0.16 to −0.02; I² = 31%; NNTB 12, 95% CI 8 to 47). Meta- analysis of 2 trials (n = 161) found a reduction in progression to stage 3 ROP (typical RR 0.60, 95% CI 0.37 to 0.96; I² = 0%; typical RD −0.15, 95% CI −0.28 to −0.02; I² = 73%; NNTB 7, 95% CI 5 to 67). There was no significant effect of oral beta-blockers on progression to stage 2 ROP with plus disease or to stage 4 or 5 ROP. Although meta-analysis did not
indicate a significant effect of beta-blockers on arterial hypotension or bradycardia propranolol dosage in one study was reduced by 50% in infants of less than 26 weeks’ gestational age due to severe hypotension, bradycardia, and apnoea in several participants. Analyses did not indicate significant effects of beta-blockers on complications of prematurity or mortality. None of the trials reported on long-term visual impairment.
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