TL;DR: Among preterm lambs with severe RDS, lucinactant produced improvements in gas exchange and lung mechanics similar to those observed with a porcine-derived surfactant, with no differences between groups.
Abstract: BACKGROUND Animal-derived, protein-containing surfactants seem to be superior to protein-free surfactants. Lucinactant, a synthetic surfactant containing a surfactant protein-B peptide analog, has been shown to be effective in animal models and phase II clinical trials. To date, lucinactant has not been compared with an animal-derived surfactant in a premature animal model. OBJECTIVE The objective was to compare the acute and sustained effects of lucinactant among premature lambs with respiratory distress syndrome (RDS) with the effects of a natural porcine surfactant (poractant-alpha). METHODS After 5 minutes of mechanical ventilation twin premature lambs were assigned randomly to the lucinactant group (30 mg/mL, 5.8 mL/kg) or the poractant-alpha group (80 mg/mL, 2.2 mL/kg). Heart rate, systemic arterial pressure, arterial pH, blood gas values, and lung mechanics were recorded for 12 hours. RESULTS Baseline fetal pH values were similar for the 2 groups (pH 7.27). After 5 minutes of mechanical ventilation, severe RDS developed (pH: 80 mm Hg; Pao2: <40 mm Hg; dynamic compliance: <0.08 mL/cm H2O per kg). After surfactant instillation, similar improvements in gas exchange and lung mechanics were observed for the lucinactant and poractant-alpha groups at 1 hour (pH: 7.3 +/- 0.1 vs 7.4 +/- 0.1; Paco2: 8 +/- 18 mm Hg vs 40 +/- 8 mm Hg; Pao2: 167 +/- 52 mm Hg vs 259 +/- 51 mm Hg; dynamic compliance: 0.3 +/- 0.1 mL/cm H2O per kg vs 0.3 +/- 0.1 mL/cm H2O per kg). The improvements in lung function were sustained, with no differences between groups. Cardiovascular profiles remained stable in both groups. CONCLUSIONS Among preterm lambs with severe RDS, lucinactant produced improvements in gas exchange and lung mechanics similar to those observed with a porcine-derived surfactant.
TL;DR: Comments related to issues concerning their recently reported trials with the new synthetic surfactant lucinactant are concerned with comments related to the following issues.
Abstract: ARTICLE In Reply .—
Drs Moya et al are concerned with comments related to the following issues concerning their recently reported trials with the new synthetic surfactant lucinactant:
1. whether previous studies have shown natural surfactants to be superior to previously developed synthetic surfactants;
2. whether lucinactant is superior or equivalent to existing synthetic surfactants; and
3. whether lucinactant is superior or equivalent to existing natural surfactants.
The answer to concern 1 has been examined in several meta-analyses and in vitro studies that have concluded convincingly that the natural surfactants are more effective biophysically, physiologically, and clinically (numerous reviews on …
TL;DR: This comprehensive pharmacoeconomic analysis indicates that lucinactant is a cost-effective therapy for the prevention of RDS among preterm infants.
Abstract: OBJECTIVE The use of exogenous surfactants among preterm infants for the prevention and treatment of respiratory distress syndrome (RDS) has led to economic and cost-effectiveness evaluations of these products. Lucinactant (Surfaxin), a novel, peptide-based, synthetic surfactant, has been shown to significantly reduce RDS-related mortality, compared with the most commonly prescribed animal-derived surfactant, beractant (Survanta). Infants who survive expend significant healthcare resources; therefore, the impact of improved survival through 1-year corrected age was evaluated in a prospectively defined pharmacoeconomic analysis. The objectives of this study were to estimate the healthcare resource utilization, economic impact, and cost-effectiveness of lucinactant versus beractant for the prevention of RDS among surviving very low birth weight (VLBW) preterm infants weighing 600 to 1250 grams. METHODS A decision-analytic model was developed to compare the healthcare resource utilization, economic impact, and cost-effectiveness of lucinactant versus beractant. RESULTS Infants who received lucinactant had fewer neonatal intensive care unit (NICU) days and fewer NICU days on mechanical ventilation compared with infants who received beractant. Total healthcare costs for the initial stay in the NICU were lower by $8,803 among infants who received lucinactant compared with infants who received beractant. The incremental cost per life saved was $40,309 for lucinactant compared with beractant. CONCLUSIONS Administration of lucinactant to surviving VLBW preterm infants resulted in fewer NICU days and fewer NICU days on mechanical ventilation compared with beractant. Fewer NICU days translates into lower total costs among infants who received lucinactant. This comprehensive pharmacoeconomic analysis indicates that lucinactant is a cost-effective therapy for the preven tion of RDS among preterm infants.
TL;DR: Dr Reingold is right in that parents of children with special health care needs would be doing their children and their families a service by looking after their own health in addition to that of their children’s by detecting the depression that is preventing them from being the kind of parent that these children need.
Abstract: To the Editor. —
We were surprised to see in the abstract of the article by Gastiasoro-Cuesta et al1 that “lucinactant produced improvements in gas exchange and lung mechanics similar to those observed with a porcine-derived surfactant” was not supported by the findings reported in the text of the publication.
From their Table 2 it is clear that arterial oxygen pressures increased much more rapidly in the poractant-α group, and the differences were sustained for at least 60 minutes …