RDS Therapies

CLINICAL HISTORY OF CUROSURF

A review of strategic studies (pdf 382 KB)

Introduction by Prof. Henry Halliday
The Queen’s University of Belfast
Northern Ireland, UK

Although the underlying cause of respiratory distress syndrome (RDS) was identified over four decades ago, it was not until the early 1990s that the first surfactants were approved for clinical use. During this time surfactant preparations underwent rigorous clinical testing. Poractant alfa (Curosurf®, Chiesi Farmaceutici), a natural porcine-derived surfactant, is one of the most extensively studied preparations having undergone a wide range of clinical trials. The purpose of the Curosurf Collection is to provide clinicians with reviews of strategic publications – from the first clinical trial to large-scale comparative, international trials – in an easy-to-use, accessible format. The Collection comprises publications spanning the period 1987-2004 and topics discussed include composition of poractant alfa, effects of dosage regimen and timing of administration on clinical outcomes, use of poractant alfa in combination with nasal continuous positive airway pressure as well as comparison studies on the efficacy and safety of natural and synthetic preparations.
These studies, including some of the largest trials performed in neonatology, demonstrate that poractant alfa decreases the severity of RDS, reduces pneumothorax, increases survival without lung disease and decreases mortality in infants with RDS. In the comparison trial by Ainsworth et al., the significantly lower mortality in neonates receiving poractant alfa compared with those on pumactant, resulted in the trial being stopped early. Furthermore, the recently published study by Ramanathan et al. demonstrated that poractant alfa at an initial dose of 200 mg/kg, allowed earlier weaning from supplemental oxygen, permitted less re-dosing and conferred a survival advantage in infants of 32 weeks, compared with beractant at an initial dose of 100 mg/kg.
Before a therapy becomes widely used and acceptable it should be both effective and safe. The publications reviewed in the Curosurf Collection provide testament to the efficacy and safety of poractant alfa and the increased survival rates among preterm infants treated with poractant alfa.