COMPARISON OF THE EFFECT OF SILDENAFIL AND TADALAFIL ON PULMONARY HYPERTENSION ASSOCIATED WITH HEMODYNAMICALLY SIGNIFICANT PDAS TREATMENT OF PULMONARY HYPERTENSION IN HS-PDA PATIENTS

Abstract

Objective: Treating the hemodynamically significant patent ductus arteriosus (hs-PDA) includes conservative therapy besides
using non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen. In addition, the pulmonary arterial pressure
increases in hs-PDA. It is not clear whether the drugs used in acute pulmonary arterial hypertension (PAH) can improve the
hs-PDA or not. This study evaluates the effect of anti-PAH drugs, sildenafil and tadalafil on patients with hs-PDA and PAH.
Methods: Neonates with hs-PDA and PAH diagnosis are included in this triple-blinded clinical randomized trial study. The
patients are assigned to group A (tadalafil + acetaminophen), B (sildenafil + acetaminophen), and C (acetaminophen alone).
The patients were evaluated by their echocardiography findings, before and after therapy. Results: Overall, 96 patients were included in this study, 32 for each group. The patients were match for all of the demographic data. All patients had improved echocardiography parameters, except for the TAPSE and MPA diameter for tadalafil patients. On the other hand, the RVEDd and RVESd were improved better in tadalafil patients, in comparison with the sildenafil group (p = 0.012 and 0.022, respectively). There was no significant difference in other echocardiography parameters or the adverse effects. Conclusions: Using anti-PAH drugs such as tadalafil and sildenafil to hs-PDA patients with PAH does not have additional effect to the acetaminophen. Tadalafil and sildenafil did not vary in efficacy and side effects. Despite the safety of adding anti-PAH drugs such as sildenafil and tadalafil, the acetaminophen itself can reduce the pulmonary pressure by closing the patent duct. Abbreviations: 5-PDEI, 5-phosphodiesterase inhibitors; hs-PDA, hemodynamically significant patent ductus arteriosus; NSAID, anti-inflammatory drug; PAH, pulmonary arterial hypertension; PAP, pulmonary artery pressure; PDA, patent ductus arteriosus; PPHN, persistent pulmonary hypertension in neonates.