Results of a Phase II, 25 patient-study with The Liposome Company's TLC C-53 (liposomal PGE1) in patients with acute respiratory distress syndrome have shown an improved mortality outcome, according to Edward Abraham from the University of Colorado, presenting at the 24th Educational and Scientific Symposium of the Society of Critical Care Medicine.
In the randomized, placebo-controlled study, 13 out of 17 (76%) treated patients had a 25% or greater improvement in lung compliance or were removed from the ventilator by day eight compared to none of the eight patients receiving placebo. By day eight, all placebo patients still required assisted ventilation versus only nine patients receiving TLC C-53. Mortality at 28 days was one patient in the group receiving therapy (6%) compared with two of eight patients in the placebo group (25%).
"This is a small study, and its results must be interpreted cautiously," said Dr Abraham. "Nonetheless," he continued, "these results are exciting, and if they are confirmed in a larger study, liposomal PGE1 could represent a breakthrough in the treatment of ARDS, a condition that typically results in a 40% to 60% mortality rate and for which there is no effective therapy."
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