- When compared to infants treated with CUROSURF, the likelihood of mortality was 49.6 percent greater for Infasurf patients (p=0.043), and 37.0 percent greater for Survanta patients (p=0.053).
- There were no differences in mortality observed between the Infasurf and Survanta groups (p=0.626).
- The unadjusted mortality rates were lowest for the infants treated with CUROSURF (3.61 percent), followed by Survanta (4.58 percent) and Infasurf (5.95 percent).
“The clinical implications of this research are important for many reasons,” said Rangasamy Ramanathan, M.D., F.A.A.P., lead author and Associate Division Chief of the Division of Neonatal Medicine at LAC+USC Medical Center and Children’s Hospital Los Angeles. “This is the first direct comparison between all three products and the largest, retrospective study with surfactants to date. This information is critical in neonatal intensive care units (NICUs) as we work to stabilize and improve outcomes in preterm infants who are struggling with RDS.”Limitations of this retrospective study include database restrictions, such as lack of information on the precise cause of death, number of surfactant doses and antenatal steroid use. This study was sponsored by Chiesi Farmaceutici S.p.A. Indication CUROSURF ® Intratracheal Suspension is indicated for the treatment (rescue) of Respiratory Distress Syndrome (RDS) in premature infants. CUROSURF ® Intratracheal Suspension reduces mortality and pneumothoraces associated with RDS. Important Safety Information CUROSURF is intended for intratracheal use only. THE ADMINISTRATION OF EXOGENOUS SURFACTANTS, INCLUDING CUROSURF, CAN RAPIDLY AFFECT OXYGENATION AND LUNG COMPLIANCE. Therefore, infants receiving CUROSURF should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified in response to respiratory changes. CUROSURF should only be administered by those trained and experienced in the care, resuscitation, and stabilization of preterm infants. TRANSIENT ADVERSE EFFECTS SEEN WITH THE ADMINISTRATION OF CUROSURF INCLUDE BRADYCARDIA, HYPOTENSION, ENDOTRACHAEL TUBE BLOCKAGE, AND OXYGEN DESATURATION. These events require stopping CUROSURF administration and taking appropriate measures to alleviate the condition. After the patient is stable, dosing may proceed with appropriate monitoring. Please see full prescribing information at www.curosurf.com .
|1. National Vital Statistics Reports (2009, March 18). Vol. 57, (12, p. 14)|
|2. National Heart Lung and Blood Institute (2009, September 01). What is Respiratory Distress Syndrome? Retrieved August 30, 2011, from http://www.nhlbi.nih.gov/health/health-topics/topics/rds|
CUROSURF ® is a registered trademark of Chiesi Farmaceutici, S.p.A.Infasurf ® is a registered trademark of ONY, Inc.Survanta ® is a registered trademark of Abbott Laboratories, Inc.