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Beractant and poractant alfa in premature neonates with respiratory distress syndrome: a systematic review of real-world evidence studies and randomized controlled trials.

ABSTRACT: Findings from previous meta-analyses of randomized clinical trials (RCTs) in premature infants with respiratory distress syndrome (RDS) varied as to whether clinical outcomes differed by type of animal-derived pulmonary surfactant; real-world evidence (RWE) was excluded. We extracted study characteristics and outcomes from full-text articles from a systematic search for studies that compared beractant with poractant alfa for RDS in preterm infants. RWE data were tabulated; RCT data were subjected to meta-analyses. Designs, patient characteristics, and follow-up durations varied widely among studies (4 RWE, 15 RCT). RWE studies with adjusted odds ratios (ORs) found no statistically significant between-treatment differences in outcomes. In RCT meta-analyses, no statistically significant between-treatment differences were observed for death (OR [95% confidence interval], 1.35 [0.98-1.86]), bronchopulmonary dysplasia (1.25 [0.96-1.62]), pneumothorax (1.21 [0.72-2.05]), and air leak syndrome (2.28 [0.82-6.39]). Collectively, outcomes were similar with beractant and poractant alfa in RWE studies and pooled RCTs.

SUBMITTER: Sanchez Luna M

PROVIDER: S-EPMC7375954 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Beractant and poractant alfa in premature neonates with respiratory distress syndrome: a systematic review of real-world evidence studies and randomized controlled trials.

Sánchez Luna Manuel M Bacher Peter P Unnebrink Kristina K Martinez-Tristani Marisol M Ramos Navarro Cristina C

Journal of perinatology : official journal of the California Perinatal Association 20200212 8

Findings from previous meta-analyses of randomized clinical trials (RCTs) in premature infants with respiratory distress syndrome (RDS) varied as to whether clinical outcomes differed by type of animal-derived pulmonary surfactant; real-world evidence (RWE) was excluded. We extracted study characteristics and outcomes from full-text articles from a systematic search for studies that compared beractant with poractant alfa for RDS in preterm infants. RWE data were tabulated; RCT data were subjecte ...[more]

PMID: 32051542

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Project description:BackgroundPoractant alfa (Curosurf®) and Bovactant (Alveofact®) are two animal-derived pulmonary surfactants preparations approved for the treatment of neonatal respiratory distress syndrome (nRDS). They differ in their source, composition, pharmaceutical form, and clinical dose. How much these differences affect the acute pulmonary response to treatment is unknown.ObjectivesComparing these two surfactant preparations in two different animal models of respiratory distress focusing on the short-term response to treatment.MethodsPoractant alfa and Bovactant were administered in a 50-200 mg/kg dose range to surfactant-depleted adult rabbits with acute respiratory distress syndrome induced by lavage and to preterm lambs (127-129 days gestational age) with nRDS induced by developmental immaturity. The acute impact of surfactant therapy on gas exchange and pulmonary mechanics was assessed for 1 h in surfactant-depleted rabbits and for 3 h in preterm lambs.ResultsOverall, treatment with Bovactant 50 mg/kg or Poractant alfa 50 mg/kg did not achieve full recovery of the rabbits' respiratory conditions, as indicated by significantly lower arterial oxygenation and carbon dioxide values. By contrast, the two approved doses for clinical use of Poractant alfa (100 and 200 mg/kg) achieved a rapid and sustained recovery in both animal models. The comparison of the ventilation indices of the licensed doses of Bovactant (50 mg/kg) and Poractant alfa (100 mg/kg) showed a superior performance of the latter preparation in both animal models. At equal phospholipid doses, Poractant alfa was superior to Bovactant in terms of arterial oxygenation in both animal models. In preterm lambs, surfactant replacement therapy with Poractant alfa at either 100 or 200 mg/kg was associated with significantly higher lung gas volumes compared to Bovactant treatment with 100 mg/kg.ConclusionAt the licensed doses, the acute pulmonary response to Poractant alfa was significantly better than the one observed after Bovactant treatment, either at 50 or at 100 mg/kg dose, in two animal models of pulmonary failure.

Project description:BackgroundNeonatal respiratory distress syndrome (RDS) is one of the most common problems for preterm infants, and symptoms include tachypnoea, grunting, retractions and cyanosis, which occur immediately after birth. Treatment with surfactants has reduced morbidity and mortality rates associated with neonatal RDS.ObjectiveThe objective of this review is to describe the treatment costs, healthcare resource utilization (HCRU) and economic evaluations of surfactant use in the treatment of neonates with RDS.MethodsA systematic literature review (SLR) was performed to identify available economic evaluations and costs associated with neonatal RDS. Electronic searches were conducted in Embase, MEDLINE, MEDLINE In-Process, NHS EED, DARE and HTAD to identify studies published between 2011 and 2021. Supplementary searches of reference lists, conference proceedings, websites of global health technology assessment bodies and other relevant sources were conducted. Publications were screened by two independent reviewers for inclusion and followed the population, interventions, comparators and outcomes framework eligibility criteria. Quality assessment of the identified studies was performed.ResultsEight publications included in this SLR met all eligibility criteria: three conference abstracts and five peer-reviewed original research articles. Four of these publications evaluated costs/HCRU, and five (three abstracts and two peer-reviewed articles) investigated economic evaluations (two from Russia, and one each from Italy, Spain and England). The main cost drivers and causes of increased HCRU were invasive ventilation, duration of hospitalization and RDS-associated complications. There were no significant differences in neonatal intensive care unit (NICU) length of stay or NICU total costs between infants treated with beractant (Survanta®), calfactant (Infasurf®) or poractant alfa (Curosurf®). However, treatment with poractant alfa was associated with reduced total costs compared with no treatment, continuous positive airway pressure (CPAP) alone or calsurf (Kelisu®), due to shorter duration of hospitalization and fewer complications. Early use of the surfactant after birth was more clinically effective and cost-effective than late intervention in infants with RDS. Poractant alfa was found to be cost-effective and cost-saving compared to beractant for the treatment of neonatal RDS in two Russian studies.ConclusionThere were no significant differences in NICU length of stay or NICU total costs between surfactants evaluated for treating neonates with RDS. However, early use of surfactant was found to be more clinically effective and cost-effective than late treatment. Treatment with poractant alfa was found to be cost-effective versus beractant and cost-saving compared with CPAP alone or beractant or CPAP in combination with calsurf. Limitations included the small number of studies, the geographic scope of the studies and the retrospective study design of the cost-effectiveness studies.

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Beractant and poractant alfa in premature neonates with respiratory distress syndrome: a systematic review of real-world evidence studies and randomized controlled trials.

Publications

Beractant and poractant alfa in premature neonates with respiratory distress syndrome: a systematic review of real-world evidence studies and randomized controlled trials.

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