Showing papers on "Lucinactant published in 2008"
TL;DR: Data suggest that Lucinactant was protective compared with Beractant and control, and indicated less injury with LucinActant relative to Beractan and saline.
Abstract: Exogenous surfactant is critical in the treatment of neonates with respiratory distress syndrome. Lucinactant (Surfaxin; Discovery Laboratories, Inc.) is a surfactant replacement therapy containing sinulpeptide, which may reduce lung inflammation. This study tested whether Lucinactant reduces markers of inflammation, damage and remodeling in human airway epithelial cells exposed to hyperoxia. Calu-3 monolayers cultured at an air–liquid interface were treated apically with 140 μL of normal saline, Lucinactant or Beractant (Survanta; Abbott Laboratories, Inc.). Treated monolayers were exposed to 60% O2/5% CO2 for 24 or 72 h. Transepithelial resistance (TER; p < 0.001) and cell viability (p < 0.05) were greater in both surfactant groups compared with saline; by 72 h Lucinactant cells had greater TER than Beractant (p < 0.001). Surfactant treated groups secreted less IL-8 than saline (p < 0.001), whereas Lucinactant cells secreted less IL-6 than saline and Beractant (p < 0.001). Matrix metalloproteinase 7, expressed by saline and Beractant treated cells at 24 h, was attenuated by 72 h by Beractant (p < 0.001), but was never detected in Lucinactant cells. Histology indicated less injury with Lucinactant relative to Beractant and saline. These data suggest that Lucinactant was protective compared with Beractant and control.
27 citations
TL;DR: Results of recent phase 3 clinical trials of Surfaxin show promising results with similar efficacy as animal derived surfactants and yet avoiding the disadvantage associated with animal products.
Abstract: Respiratory distress syndrome (RDS) is a leading cause of mortality and morbidity in preterm infants. Surfactant replacement therapy has been widely used to prevent and treat RDS in these newborns and has now become a standard of care. First-generation synthetic surfactants such as Exosurf did not contain any surfactant protein. This disadvantage was overcome with animal-derived surfactant preparations which contain specific proteins but has the limitation of being derived from animal sources. This has led to development of newer synthetic surfactants such as lucinactant (Surfaxin, Discovery Laboratories, Philadelphia) which contains the protein B mimic synthetic peptide, sinapultide. Recent phase 3 clinical trials with Surfaxin show promising results with similar efficacy as animal derived surfactants and yet avoiding the disadvantage associated with animal products. The purpose of this paper is to summarise results of recent clinical trials of Surfaxin use in newborns with RDS.
16 citations
TL;DR: Lab studies confirm the ability of lucinactant to withstand the aerosolization process and to maintain its biological activity and the justification for a larger Phase III trial.
Abstract: Background: Surfactant replacement therapy (SRT) has been demonstrated to be both safe and highly effective in the treatment of preterm infants with respiratory distress syndrome (RDS). However, administration of the various available suspensions has required endotracheal intubation and its inherent risks. Delivery of aerosolized SRT would be a laudable goal. Objective: To review the chemistry, pharmacodynamics, clinical efficacy and safety of aerosolized lucinactant for the prevention/treatment of RDS in the preterm infant. Methods: Laboratory and clinical experience with aerosolized lucinactant are reviewed. Results/conclusions: Laboratory studies confirm the ability of lucinactant to withstand the aerosolization process and to maintain its biological activity. A small clinical pilot trial demonstrated safety and feasibility and provided a signal to suggest proof of concept and the justification for a larger Phase III trial.
14 citations
TL;DR: This document was comprehensive in scope yet sufficiently detailed and referenced to provide practical, evidence-based guidance to the clinician who renders neonatal care, but the attempt to summarize information from so many studies has led to inaccurate statements that, if left uncorrected, are misleading.
Abstract: To the Editor. —
We would like to express our congratulations to Dr Engle and the American Academy of Pediatrics Committee on Fetus and Newborn on the publication of their clinical report “Surfactant-Replacement Therapy for Respiratory Distress in the Preterm and Term Neonate.” Overall, this document was comprehensive in scope yet sufficiently detailed and referenced to provide practical, evidence-based guidance to the clinician who renders neonatal care. However, the attempt to summarize information from so many studies has led to inaccurate statements that, if left uncorrected, are misleading.
The report stated that “[w]hen compared with infants receiving the animal-derived surfactants beractant and poractant alfa, infants receiving lucinactant were found to have similar rates of mortality and morbidity from respiratory distress syndrome [RDS].”1 One of the studies cited in connection with this statement is the Safety and Effectiveness of Lucinactant Versus Exosurf in a Clinical Trial of RDS in Premature Infants (SELECT) study. …
9 citations
Journal Article•
3 citations
TL;DR: In this article, the effects on mortality and morbidity of the novel synthetic surfactant lucinactant compared with animal-derived surfactants (beractant or poractant alfa) as described in the American Academy of Pediatrics Committee on Fetus and Newborn (COFN) clinical report entitled “Surfactant-Replacement Therapy for Respiratory Distress in the Preterm and Term Neonate.
Abstract: We are responding to the concerns raised by Moya et al regarding the effects on mortality and morbidity of the novel synthetic surfactant lucinactant compared with animal-derived surfactants (beractant or poractant alfa) as described in the American Academy of Pediatrics Committee on Fetus and Newborn (COFN) clinical report entitled “Surfactant-Replacement Therapy for Respiratory Distress in the Preterm and Term Neonate.”1
In the Safety and Effectiveness of Lucinactant Versus Exosurf in a Clinical Trial of RDS in Premature Infants (SELECT) trial, respiratory distress syndrome (RDS) at 24 hours …
3 citations
TL;DR: A peptide-containing synthetic surfactant, lucinactant (Surfaxin), has been recently tested in comparison to a synthetic drug that does not contain protein as well as to animal derived drug as discussed by the authors.
Abstract: There are numerous pulmonary conditions in which qualitative or quantitative anomalies of the surfactant system have been demonstrated. In premature newborns with immature lungs, a functional deficit in surfactant is the main physiopathologic mechanism of the neonatal respiratory distress syndrome (RDS). Since the landmark pilot study of Fujiwara, published more than 20 years ago, the efficacy of exogenous surfactant for the treatment of neonatal RDS has been established by numerous controlled studies and meta-analyses. Enlightened by a growing insight into both the structure and function of the different surfactant components, a new generation of synthetic surfactants has been developed. Various complementary approaches have confirmed the fundamental role of the two hydrophobic proteins, SP-B and SP-C, in the surfactant system, thus opening the way to the design of analogues, either by chemical synthesis or expression in a prokaryotic system. An example of these peptide-containing synthetic surfactant preparations, lucinactant (Surfaxin), has been recently tested in comparison to a synthetic surfactant that does not contain protein as well as to animal derived surfactant preparations. Major clinical outcomes between lucinactant and animal-derived surfactant preparations were fund similar in two randomized controlled trials, opening the way to a new generation of synthetic surfactants in the near future.
2 citations