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A randomized, double-blind, placebo-controlled, prospective study of bosentan for the treatment of persistent pulmonary hypertension of the newborn
Faculty
Not Specified
Year:
2012
Type of Publication:
Article
Pages:
608-613
Authors:
Ismail, M, Mohamed, W. A
DOI:
10.1038/jp.2011.157
Journal:
JOURNAL OF PERINATOLOGY NATURE PUBLISHING GROUP
Volume:
32
Research Area:
Obstetrics \& Gynecology; Pediatrics
ISSN
ISI:000307015600009
Keywords :
bosentan, persistent pulmonary hypertension, neonates
Abstract:
Objective: To assess the efficacy and safety of bosentan as an adjuvant therapy of persistent pulmonary hypertension of the newborn (PPHN). Study Design: Forty-seven neonates with PPHN were randomly assigned to receive either bosentan (n = 24) or placebo (n = 23). Efficacy was evaluated with a favorable outcome defined as fulfilling all the following criteria (for example, oxygenation index <15, normal pulmonary artery pressure (< 20mm Hg) and no premature discontinuation of the drug because of drug-related toxicity or lack of efficacy). Evaluation of safety was done by monitoring drug-related adverse events. Result: Bosentan treatment was superior to placebo with a favorable response in 87.5\% of patients treated with bosentan as compared with 20\% of those who received placebo (P < 0.0001). None of patients in the bosentan group had drug-related clinical or laboratory adverse events. Conclusion: Bosentan may be a useful adjuvant therapy of PPHN. Journal of Perinatology (2012) 32, 608-613; doi: 10.1038/jp.2011.157; published online 10 November 2011
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