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Comparison of Surfactants
Moya FR, Gadzinowski J,
Bancalari E, Salinas
V et al.
A
Multicenter, Randomized, Masked, Comparison Trial of Lucinactant, Colfosceril
Palmitate, and Beractant for the Prevention of Respiratory Distress Syndrome
Among Very Preterm Infants. Pediatrics 2005;115:118-129.
Background and Objective:
Evidence suggests that synthetic surfactants consisting solely of
phospholipids can be improved through the addition of peptides, such
as sinapultide, that mimic the action of human surfactant protein-B
(SP-B). A synthetic surfactant containing a mimic of SP-B may also
reduce the potential risks associated with the use of animal-derived
products. Our objective was to compare the efficacy and safety of a
novel synthetic surfactant containing a functional SP-B mimic (lucinactant;
Discovery Laboratories, Doylestown, PA) with those of a
non–protein-containing synthetic surfactant (colfosceril palmitate;
GlaxoSmithKline, Brentford, United Kingdom) and a bovine-derived
surfactant (beractant; Abbott Laboratories, Abbott Park, IL) in the
prevention of neonatal respiratory distress syndrome (RDS) and RDS-related
death.
Methods: We assigned
randomly (double-masked) 1294 very preterm infants, weighing 600 to
1250 g and of 
32
weeks gestational age, to receive colfosceril palmitate (n =
509), lucinactant (n = 527), or beractant (n = 258)
within 20 to 30 minutes after birth. Primary outcome measures were
the rates of RDS at 24 hours and the rates of death related to RDS
during the first 14 days after birth. All-cause mortality rates,
bronchopulmonary dysplasia (BPD) rates, and rates of other
complications of prematurity were prespecified secondary outcomes.
Primary outcomes, air leaks, and causes of death were assigned by an
independent, masked, adjudication committee with prespecified
definitions. The study was monitored by an independent data safety
monitoring board.
Results: Lucinactant
reduced significantly the incidence of RDS at 24 hours, compared with
colfosceril (39.1% vs. 47.2%; odds ratio [OR]: 0.68; 95% confidence
interval [CI]: 0.52–0.89). There was no significant difference in
comparison with beractant (33.3%). However, lucinactant reduced
significantly RDS-related mortality rates by 14 days of life,
compared with both colfosceril (4.7% vs. 9.4%; OR: 0.43; 95% CI:
0.25–0.73) and beractant (10.5%; OR: 0.35; 95% CI: 0.18–0.66). In
addition, BPD at 36 weeks postmenstrual age was significantly less
common with lucinactant than with colfosceril (40.2% vs. 45.0%; OR:
0.75; 95% CI: 0.56–0.99), and the all-cause mortality rate at
36 weeks postmenstrual age was lower with lucinactant than with
beractant (21% vs. 26%; OR: 0.67; 95% CI: 0.45–1.00).
Conclusions:
Lucinactant is a more effective surfactant preparation than
colfosceril palmitate for the prevention of RDS. In addition,
lucinactant reduces the incidence of BPD, compared with colfosceril
palmitate, and decreases RDS-related mortality rates, compared with
beractant. Therefore, we conclude that lucinactant, the first of a
new class of surfactants containing a functional protein analog of
SP-B, is an effective therapeutic option for preterm infants at risk
for RDS.
Comment: [Refer also to the subsequent article (a comparison
of the prophylactic use of lucinactant and Curosurfâ)
and also to the commentary by Dr. Kattwinkel]. These are the first trials
that compare the synthetic surfactant Surfaxinâ
to other approved surfactants. Overall the data from these two studies
suggest that lucinactant is an effective surfactant for the prophylaxis of RDS.
Given the fact that rather large comparative surfactant trials have not
consistently distinguished differences in major endpoints (e.g., survival to
discharge, survival without BPD), these trials were designed as
“non-inferiority” (vs. the traditional “superiority”) trials. There are some
reasons why an effective totally synthetic surfactant might be preferable to
the currently available animal-derived products (potential infection concerns,
immunogenicity), but these concerns are still hypothetical. What these
studies do not adequately reference is a complete catalog of how lucinactant
compares to other surfactants on the multiple pre-clinical assays of
efficacy. It is my belief that the efficacy of surfactants for the
prophylaxis and treatment of acute RDS correlates extremely well with these
assays. The difficulty that randomized studies have encountered in
differentiating these surfactants results from the inability to control for
the many other confounding clinical variables and multi-organ disease
conditions. MLH.
Additional Comments:
Date: 22 May 2005
Time: 06:55:01
It's interesting, did the efficacy of these surfactants be better than
"traditional", so as exusurf-neonatal, kurosurf of surfactants-BL and HL? If
were the investigations publicated?
UserName: Prometnoy Dmitry
Institution: Rostov State Medical Univercity, Clinical Hospital #20
telephone: +78632719792
email: prometey_d@mail.ru
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