Despite previously-reported observational and basic science evidence suggesting the use of statins may improve outcomes in patients with sepsis and acute respiratory distress syndrome (ARDS), a double-blinded clinical trial of rosuvastatin in those patients was futile, and the study was halted.
The findings are published in the May 18, 2014 New England Journal of Medicine, along with accompanying editorials evaluating the research's goals and outcomes. The primary investigator and lead author of the study is Jonathon D. Truwit, M.D., professor of medicine and enterprise chief medical officer and senior administrative dean at Froedtert & the Medical College of Wisconsin.
Despite improvements in supportive care for ARDS, the mortality rate remains high, one in four patients die. Sepsis is the major reason patients develop ARDS. Statins have been shown to reduce inflammation and prevent ARDS in basic science studies, and have also been reported in observational studies to improve outcomes in patients with sepsis and ARDS.
In this study, patients received either the rosuvastatin or a placebo, and the study was double-blinded. After 745 of the proposed 1000 patients had been enrolled in the multi-center trial, the study was halted because there was no significant difference between the study groups. Further, the rosuvastatin therapy may have contributed to hepatic and renal organ dysfunction.
"While this therapy did not lead to better outcomes, it is important that we evaluate possible therapies for conditions such as ARDS because it adds to our knowledge about this condition, which has a high mortality rate for patients. The information gathered in this study will guide further basic and clinical research to ultimately improve our care for critically ill patients," said Dr. Truwit.
The other members of the writing committee for the paper are Gordon R. Bernard, M.D., Vanderbilt University, Nashville; Jay Steingrub, M.D., Baystate Medical Center, Springfield, MA, and Tufts University School of Medicine, Boston; Michael A. Matthay, M.D., and Kathleen
D. Liu, M.D., Ph.D., University of California, San Francisco, San Francisco; Timothy E. Albertson, M.D., Ph.D., University of California - Davis, Sacramento; Roy G. Brower,M.D., Johns Hopkins University, and Carl Shanholtz, M.D., and Peter Rock, M.D., University of Maryland -- both in Baltimore; Ivor S. Douglas, M.D., Denver Health Medical Center and University of Colorado, Denver; Bennett P. deBoisblanc, M.D., Louisiana State University Health Sciences Center, New Orleans; Catherine L. Hough, M.D., University of Washington, Seattle; R. Duncan Hite, M.D., Cleveland Clinic, Cleveland; and B. Taylor Thompson, M.D., Massachusetts General Hospital and Harvard Medical School, Boston.
This study was supported by a grant from the National Institutes of Health's National Heart, Lung and Blood Institute and the investigator-sponsored study program of AstraZeneca.