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Neonatal Intensive Care Drug Manual
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| bet | 515/654 | | Sana | 03.01.2022 | | Hajmi | 1,5 Mb. | | #14803 |
Conclusion: Limited evidence of low-to-moderate quality suggests that prophylactic administration of oral beta-blockers might reduce progression to stage 3 ROP and decrease the need for anti-VEGF agents or laser therapy. The clinical relevance of those findings is unclear as no data on long-term visual impairment were reported. Adverse events attributed to oral propranolol at a dose of 2 mg/kg/d raise concerns regarding systemic administration of this drug for prevention of ROP at the given dose. There is insufficient evidence to determine the efficacy and safety of beta-blockers for prevention of ROP. [LOE I GOR D]
Heart failure: Two clinical trials have reported use of propranolol in infants with heart failure from congenital heart disease with left to right shunts [8, 9]. Buchhorn et al 2001 [9] compared propranolol 1 to 2 mg/kg/day + digoxin and diuretics (n = 10) versus digoxin and diuretics alone (n = 10) and reported propranolol improved the Ross heart failure score, lowered renin levels and lowered mean heart rates, whilst digoxin and diuretic treated infants had unchanged mean heart rate, less decrease of symptoms and a significant increase of renin levels. Ahuja et al 2013 [8] compared propranolol 1 to 2 mg/kg/day + diuretics and digoxin (n = 40) versus diuretics and digoxin (n = 40) in infants with ventricular septal defect and congestive heart failure. Fourteen (35%) patients in the conventional arm and 10 (25%) in the beta-blocker arm reached the primary endpoint (composite endpoint of death, hospitalisation and referral for surgery). Worsening of heart failure occurred more commonly in the conventional treatment arm compared to the propranolol arm (27.5 vs 5%; p = 0.015). Two patients in the conventional treatment arm and one patient in the propranolol arm died. No episodes of bradycardia or bronchospasm were reported with propranolol treatment. A systematic review [10] of beta-blockers for congestive heart failure included 7 studies (420 paediatric participants). Aetiologies of heart failure and beta-blocker varied between studies. Participants had a background of dilated cardiomyopathy in 3 trials, and congenital heart disease in 5 trials. Two trials (Ahuja 2013; Buchhorn 2001) investigated propranolol; Ghader 2009 studied metoprolol, and 4 trials carvedilol (Azeka 2002; Huang 2013; Ontoseno 2014). No difference in mortality and heart transplantation rates were reported between beta-blocker and control groups in 3 trials (Ahuja 2013; Azeka 2002; Shaddy 2007). An improvement in heart failure was reported in 4 trials (Ahuja 2013; Azeka 2002; Buchhorn 2001; Huang 2013); although an improvement could not be shown in a larger trial of carvedilol that included 161 children aged 3 months to 17 years (Shaddy 2007). No severe adverse events were reported the studies, apart from one episode of complete atrioventricular block. There was a small improvement in echocardiographic parameters LVEF and LVFS (Azeka 2002; Huang 2013; Shaddy 2007). Conclusion: There is not enough evidence to support or discourage the use of beta-blockers in children or to propose a paediatric dosing scheme. However, the existing data suggest that children with congestive heart failure might benefit from treatment with beta-blockers.[10] [LOE I GOR C]
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