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Search #ABSTRACT#
Clinical Studies
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Curosurf has been extensively studied, with more than 800 articles referencing the use of Curosurf in both the United States and Europe. In the U.S., Curosurf is indicated for the treatment of RDS.
The clinical efficacy of Curosurf was demonstrated in one single-dose study (Study 1) and one multiple-dose study (Study 2) in the treatment of established neonatal RDS involving approximately 500 infants. Each study was randomized, multiCenter, and controlled.
In Study 1, infants 700-2000g birth weight with RDS requiring mechanical ventilation and a FiO2>0.60 were enrolled. Curosurf 2.5 mL/kg single dose (200 mg/kg) or control (disconnection from the ventilator and manual ventilation for two minutes) was administered after RDS developed and before 15 hours of age. The results from Study 1 are shown below in Table 1:
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Table 1: Results of Study 1
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EFFICACY PARAMETER
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SINGLE-DOSE
CUROSURF
n=78
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CONTROL
n=67
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P-VALUE
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%
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%
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Mortality at 28 Days (all causes)
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21
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48
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<= 0.05 |
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Bronchopulmonary Dysplasia 1
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18
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22
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N.S.
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Pneumothorax
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21
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36
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<= 0.05
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Pulmonary Interstitial Emphysema
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21
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38
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<= 0.05
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1.
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Bronchopulmonary dysplasia (BPD) diagnosed by positive x-ray and supplemental oxygen dependence at 28 days of life.
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N.S.:
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not statistically significant
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In Study 2, infants 700-2000g birthweight with RDS requiring mechanical ventilation and a FiO2>0.60 were enrolled. In this two-arm trial, Curosurf was administered after RDS developed and before 15 hours of age, as a single-dose or as multiple doses. In the single-dose arm, infants received Curosurf 2.5 mL/kg (200 mg/kg). In the multiple-dose arm, the initial dose of Curosurf was 2.5 mL/kg (200 mg/kg) and subsequent doses of Curosurf were 1.25 mL/kg (100 mg/kg). The results from Study 2 are shown below in Table 2:
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Table 2: Results of Study 2
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EFFICACY PARAMETER
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SINGLE-DOSE
CUROSURF
n=184
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CONTROL
n=173
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P-VALUE
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%
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%
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Mortality at 28 Days (all causes)
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21
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13
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0.048
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Bronchopulmonary Dysplasia
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18
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18
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N.S.
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Pneumothorax
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17
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9
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0.03
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Pulmonary Interstitial Emphysema
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27
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22
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N.S.
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N.S.:
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not statistically significant
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Adverse Reactions
Transient adverse effects seen with the administration of Curosurf include bradycardia, hypotension, endotracheal tube blockage, and oxygen desaturation. The rates of common complications of prematurity observed in Study 1 are shown below in Table 3:
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Table 3: Complications of Prematurity
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CUROSURF 2.5 mL/kg
(200 mg/kg)
n=78
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CONTROL1
n=66
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%
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%
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Acquired Pneumonia
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17
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21
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Acquired Septicemia
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14
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18
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Bronchopulmonary Dysplasia
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18
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22
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Intracranial Hemorrhage
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51
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64
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Patent Ductus Arteriosus
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60
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48
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Pneumothorax
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21
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36
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Pulmonary Interstitial Emphysema
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21
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38
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1.
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Control patients were disconnected from the ventilator and manually ventilated for two minutes. No surfactant was instilled.
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Immunological studies have not demonstrated differences in levels of surfactant-anti-surfactant immune complexes and anti-Curosurf antibodies between patients treated with Curosurf and patients who received control treatment.
The Evidence-Based Compendium for Curosurf includes the complete bibliography of Curosurf from 1985-2001 on CD. Please contact us at 800-755-5560 to obtain a copy for your review.
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