Abstract
Background: Animal-derived, protein-containing surfactants perform better vs. non–protein-containing surfactants for prevention and treatment of Respiratory Distress Syndrome (RDS). A new generation, non–animal-derived surfactant, Surfaxin, containing a peptide that mimics the action of human SP-B, has been shown to be effective in animals, in studies of infants with RDS,1 and in large, controlled studies in the prevention of RDS in preterm infants. Our objective was to compare the incidence of all-cause mortality at Days 14 and 28, and at 36 weeks postconceptional age of Surfaxin vs. Survanta and Surfaxin vs. Curosurf across two clinical trials measuring their respective safety and efficacy in the prevention of RDS.
Methods: A pooled analysis was performed across the only two Phase 3, masked, multinational, randomized trials comparing Surfaxin (5.8 mL/kg or 175 mg/kg) vs. Survanta (4.0 mL/kg or 100 mg/kg) and Curosurf (2.2 mL/kg or 175 mg/kg). All randomized patients were included. Endpoint definitions were the same for both trials. Adjustments were performed for birth weight (BW) strata and study centers. Inclusion criteria: BW 600–1250 g, gestational age <32 weeks, and successful intubation. Dosing and administration occurred within 30 min of birth. P values were calculated to assess treatment group differences using logistic regression adjusting for study center and BW strata.
Results: The pooled analysis of the two trials comparing Surfaxin with animal-derived surfactants is presented below: See table.
Conclusion: Combined data from these trials show lower all-cause mortality with Surfaxin than with the animal-derived surfactants (combined results of Survanta and Curosurf). Since Surfaxin has a higher concentration of surfactant apoprotein-equivalents—in the form of sinapultide—than any other commercially available surfactant, these results are consistent with the hypothesis that both the presence of, and a higher concentration of, surfactant protein amplify the benefits of surfactant therapy.
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Moya, F., Sinha, S., Segal, R. et al. 195 Comparison of Incidences of All-Cause Mortality Between The Novel Surfactant, Surfaxin (Lucinactant) and The Animal Derived Surfactants Survanta (Beractant) and Curosurf (Poractant Alfa). Pediatr Res 56, 497 (2004). https://doi.org/10.1203/00006450-200409000-00218
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DOI: https://doi.org/10.1203/00006450-200409000-00218