Comparison of the effects of bosentan and sildenafil in the treatment of persistent pulmonary arterial hypertension in infants

Abstract

Background: Persistent pulmonary hypertension (PPHN) is a life-threatening condition in neonates. In developing countries, mortality is estimated to be around 10%–20% due to lack of access to the main drug, inhaled nitric oxide. Bosentan as an endothelin type A and B receptor antagonist and sildenafil as a phosphodiesterase inhibitor type 5 are effective in reducing pulmonary vascular resistance and pulmonary artery pressure (PAP). Materials and Methods: A double-blind clinical trial was conducted at the intensive care unit of Akbarabadi Hospital Tehran between October 2017 and September 2019. The efficacy, safety, and possible side effects of bosentan and sildenafil were evaluated in neonates suffering from PPHN. Echocardiographic findings, duration of oxygen dependency, invasive ventilation support requirement, duration of medication, short-term outcomes including blood pressure, white blood cell, and hemoglobin counts were compared between the two groups. Results: Bosentan is as effective as sildenafil in reducing PAP and improving cardiac output. The duration of treatment with bosentan was significantly shorter than that of sildenafil (P = 0.002). The time of oxygen demand was similar between both the groups, ranging from 15 to 17 days (P = 0.198). The need for invasive ventilation support was similar in both the groups (P = 0.989). Although PAP and the severity of tricuspid valve insufficiency were higher before treatment, the third echocardiographic findings such as pulmonic insufficiency (P = 0.194), tricuspid regurgitation (P = 0.368), and ejection fraction (P = 0.160) were similar in bosentan and sildenafil groups. The need for supportive inotropic drugs was similar in both the groups. There was no statistically significant difference in the mean of blood pressure, white blood cell, and hemoglobin counts between the two groups.Conclusion: Bosentan is effective in the treatment of PPHN in neonates and reduces it over a shorter period of time. It is more efficient in reducing PAP and decreases the severity of tricuspid valve insufficiency in a shorter time compared to sildenafil.