Key result
Combined therapy with Apotel plus Sildenafil or Bosentan did not significantly improve echocardiographic parameters compared to Apotel alone in preterm infants with PDA and PAH, but was associated with higher rates of bronchopulmonary dysplasia and retinopathy of prematurity.
Why the study?
Although sildenafil and bosentan improve pulmonary arterial hypertension, no study had compared their effects in improving preterm infants with hemodynamically significant patent ductus arteriosus and pulmonary arterial hypertension.
Does the addition of sildenafil or bosentan to Apotel improve echocardiographic parameters of pulmonary arterial hypertension in preterm neonates with patent ductus arteriosus?
RCT (n=150)
Blinded
Randomized
No
Does the addition of sildenafil or bosentan to Apotel improve echocardiographic parameters of pulmonary arterial hypertension in preterm neonates with patent ductus arteriosus?
p-value: p=>0.05
In preterm infants with PDA and PAH, monotherapy with Apotel is as effective as combined therapy with sildenafil or bosentan for improving echocardiographic parameters, while avoiding the increased risk of BPD and ROP seen with the combination therapies.
Apotel monotherapy matches combined regimens for echocardiographic parameters in preterm PDA-PAH; challenges addition of sildenafil or bosentan due to higher BPD/ROP.
Background : Pulmonary arterial hypertension (PAH) is a common disorder in preterm neonates caused by patent ductus arteriosus (PDA). Although both sildenafil and bosentan have been shown to improve PAH, there is no study to compare the effect of these drugs in improving preterm infants with hemodynamically significant PDA and PAH. This study aimed to compare the therapeutic efficacy, safety, and possible side effects of combined therapies with Apotel + Bosentan, Apotel + Sildenafil, and Apotel alone in treating PDA and PAH in preterm infants. Methods: This clinical trial was conducted on 150 preterm neonates with PDA and PAH. Neonates were then divided into three groups and orally administrated with Apotel alone (10 mg/kg), Apotel (10 mg/kg) + Sildenafil (1 mg/kg), and Apotel (10 mg/kg) + Bosentan (1 mg/kg). Echocardiographic examination was performed before and 72h after the intervention. Results: Treatments with Apotel, Apotel + sildenafil, and Apotel + bosentan significantly decreased the mean of RV1, RV2, RV3, RVEDA, RVESA, RV/LV, TR intensity, TR PG, PI PG, and MPA diameter compared to before intervention (p<0.01). The mean of TAPSE after Apotel, Apotel + sildenafil, and Apotel + Bosentan administrations was significantly increased compared to before the study, indicating improvement in RV performance (p<0.01). The frequency of BPD and ROP in Apotel group (7.7% and 19.2%, respectively) was significantly lower than that in Apotel + sildenafil group (30% and 45%, respectively) and Apotel + bosentan (25% and 40%, respectively) groups (p<0.05). Conclusion: Oral administration of sildenafil and bosentan improved cardiac index beside its side effects in preterm infants PAH and PDA. Future clinical trial studies with larger sample sizes and long-term follow-up on term or near term neonates are recommended. Trial registration: IR.IUMS.FMD.REC.1399.430
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Radgoudarzi et al. (2022) conducted an RCT in Patent ductus arteriosus (PDA) and pulmonary arterial hypertension (PAH) (n=150). Sildenafil or Bosentan combined with Apotel vs. Apotel alone (10 mg/kg every 6 hours) was evaluated on Mean difference in echocardiography parameters (e.g., RV1, RV2, RV3, TAPSE) between groups at 72 hours (p=>0.05). Combined therapy with Apotel plus Sildenafil or Bosentan did not significantly improve echocardiographic parameters compared to Apotel alone in preterm infants with PDA and PAH, but was associated with higher rates of bronchopulmonary dysplasia and retinopathy of prematurity.
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