Effect of Recombinant Surfactant Protein CBased Surfactant on the Acute Respiratory Distress Syndrome
Roger G. Spragg, M.D., James F. Lewis, M.D., Hans-Dieter Walmrath, M.D., Jay Johannigman, M.D., Geoff Bellingan, M.D., Pierre-Francois Laterre, M.D., Michael C. Witte, M.D., Guy A. Richards, M.D., Gerd Rippin, Ph.D., Frank Rathgeb, M.D., Dietrich Häfner, M.D., Friedemann J.H. Taut, M.D., and Werner Seeger, M.D.
Background Preclinical studies suggest that exogenous surfactantmay be of value in the treatment of the acute respiratory distresssyndrome (ARDS), and two phase 2 clinical trials have showna trend toward benefit. We conducted two phase 3 studies ofa protein-containing surfactant in adults with ARDS.
Methods In two multicenter, randomized, double-blind trialsinvolving 448 patients with ARDS from various causes, we comparedstandard therapy alone with standard therapy plus up to fourintratracheal doses of a recombinant surfactant protein Cbasedsurfactant given within a period of 24 hours.
Conclusions The use of exogenous surfactant in a heterogeneouspopulation of patients with ARDS did not improve survival. Patientswho received surfactant had a greater improvement in gas exchangeduring the 24-hour treatment period than patients who receivedstandard therapy alone, suggesting the potential benefit ofa longer treatment course.
Source Information
From the University of California at San Diego, San Diego (R.G.S.); the University of Western Ontario, London, Ont., Canada (J.F.L.); Justus Liebig-University, Giessen, Germany (H.-D.W., W.S.); the University of Cincinnati Hospital, Cincinnati (J.J.); the Department of Medicine, University College London, London (G.B.); St. Luc University Hospital, Brussels (P.-F.L.); Mercy Medical Center, Des Moines, Iowa (M.C.W.); University of the Witwatersrand, Johannesburg (G.A.R.); Omnicare Clinical Research, Cologne, Germany (G.R.); and Altana Pharma, Konstanz, Germany (F.R., D.H., F.J.H.T.).
Address reprint requests to Dr. Spragg at the University of California at San Diego Veterans Affairs Medical Center, 3350 La Jolla Village Dr., San Diego, CA 92014, or at rspragg{at}ucsd.edu, or to Dr. Seeger at werner.seeger{at}innere.med.uni-giessen.de.
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