Combination therapy for life-threatening pulmonary hypertension in a premature infant: first report on bosentan use

Radicioni, Maurizio; Bruni, Alessia; Camerini, Piergiorgio

doi:10.1007/s00431-011-1422-9

Cited by 28 publications

(18 citation statements)

References 22 publications

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“…Efficacy and safety of bosentan in our patients are consistent with those previously described for this treatment in neonates. 9,13,14 Infants with PPHN who survived are at a high risk for neurodevelopmental abnormalities including hearing impairment both because of the nature of this illness and hypoxemia. 20,21 At 6-month follow-up evaluation, the overall PPHN major sequelae was significantly lower in infants treated with bosentan than in those given placebo.…”

Section: Discussionmentioning

confidence: 99%

“…Therefore, the dose and interval used in this study were based on doses successfully used in the previous studies. 9,13,14 Mean arterial pressure, arterial blood gas, oxygenation index (OI), pulse oxygen saturation (SpO 2 ), serum bilirubin, liver enzymes, alkaline phosphatase, serum creatinine and serum electrolytes were determined at the time of enrollment of patients in the study as a baseline assay. Arterial blood gases were monitored from an umbilical arterial catheter, and OI was calculated in every arterial blood gas using the partial pressure of arterial oxygen (PaO 2 ) from the umbilical arterial catheter and the following formula to calculate OI: OI ¼ (fraction of inspired oxygen Â mean airway pressure)/PaO 2 .…”

Section: Patient Assignmentmentioning

confidence: 99%

“…To our knowledge, only four case reports in the literature have documented using bosentan in neonates with PPHN. 9,13,14 This study was designed to assess the efficacy, safety and tolerability of bosentan as an adjuvant therapy for neonates with PPHN.…”

Section: Introductionmentioning

confidence: 99%

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A randomized, double-blind, placebo-controlled, prospective study of bosentan for the treatment of persistent pulmonary hypertension of the newborn

Mohamed

Ismail

2011

J Perinatol

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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 ¼ 24) or placebo (n ¼ 23). Efficacy was evaluated with a favorable outcome defined as fulfilling all the following criteria (for example, oxygenation index <15, normal pulmonary artery pressure (<20 mm 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.

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Section: Discussionmentioning

confidence: 99%

Section: Patient Assignmentmentioning

confidence: 99%

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A randomized, double-blind, placebo-controlled, prospective study of bosentan for the treatment of persistent pulmonary hypertension of the newborn

Mohamed

Ismail

2011

J Perinatol

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“…As significantly improved oxygenation has been seen after bosentan use without significant adverse effects, it may be used as adjuvant therapy in PPHN, especially in resource-limited countries [62,63].…”

Section: Bosentanmentioning

confidence: 99%

Persistent Pulmonary Hypertension of the Newborn: Recent Advances in the Management

Agarwal

2013

Int J Clin Pediatr

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Persistent pulmonary hypertension of the newborn (PPHN) is a medical emergency in the neonatal period, which occurs due to failure of normal postnatal transition of fetal circulation. Despite availability of numerous treatment modalities, associated mortality and morbidity remain high. Therefore, awareness of predisposing conditions, and early diagnosis and management may help improving outcome in PPHN. To provide an overview of anatomic and functional anomalies of PPHN, and available treatment options with special focus on recent advances in the diagnosis and management of this potentially lethal illness. MEDLINE, EMBASE, The Cochrane Library, and Google Scholar databases were searched (inception until Nov-2012) using terms "persistent pulmonary hypertension of newborn", "hypoxemic respiratory failure", "nitric oxide", "sildenafil", "milrinone" and "prostacyclin" without any language restriction. www.clinicaltrials.gov website was searched for relevant ongoing trials. Additionally, manual review of article bibliographies was done for potentially relevant studies. Strategies for the management of PPHN are undergoing metamorphosis. Gentle ventilation and high-frequency ventilation have replaced prior hyperventilation strategy. Currently, iNO is the only FDA-approved selective pulmonary vasodilator for infants with hypoxemic respiratory failure/PPHN; however, it has poor/no response in upto 30% cases. Recent studies have provided evidences for the use of other therapeutic agents such as PDE-inhibitors, magnesium sulphate and prostacyclin analogues. Finally, recent laboratory studies have demonstrated the role of oxidant stress as well as potential use of free radical scavengers for example, superoxide dismutase and catalase in the management of PPHN. Assisted ventilation and pharmacologic manipulation are the mainstays of treatment of PPHN. Limited availability of the gold standard treatment option namely iNO, especially in resource-limited countries, leads to increasing use of alternative therapeutic options such as PDE-inhibitors (sildenafil and milrinone). However, as any single therapy can not be labelled as a magic bullet for PPHN, further clinical trials are required to demonstrate the efficacy and safety of available therapeutic options as well as to develop newer strategies targeted to the underlying pathophysiology.

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“…ECMO, however, is a very invasive therapy and can only be administered in limited institutions. On the other hand, various alternative pulmonary vasodilator drugs for PPHN have been reported, such as sildenafil, beraprost, or bosentan [4][5][6]. We successfully treated a patient with PPHN caused by meconium aspiration syndrome (MAS) with iNO, sildenafil, and bosentan.…”

Section: Introductionmentioning

confidence: 99%

Combination Drug Therapy for Persistent Pulmonary Hypertension of the Newborn

Yokoo¹,

Marumo²,

Nishida³

et al. 2017

Health Edu Care

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Combination therapy for life-threatening pulmonary hypertension in a premature infant: first report on bosentan use

Cited by 28 publications

References 22 publications

A randomized, double-blind, placebo-controlled, prospective study of bosentan for the treatment of persistent pulmonary hypertension of the newborn

A randomized, double-blind, placebo-controlled, prospective study of bosentan for the treatment of persistent pulmonary hypertension of the newborn

Persistent Pulmonary Hypertension of the Newborn: Recent Advances in the Management

Combination Drug Therapy for Persistent Pulmonary Hypertension of the Newborn

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