Study: Statins don’t reduce mortality rates or days off the breathing machine in sepsis-associated ARDS

Clinicians should not start or continue statins in patients with sepsis-associated acute respiratory distress syndrome (ARDS), according to a study published in the May 18, 2014, New England Journal of Medicine, along with accompanying editorials evaluating the research’s goals and outcomes.

“Statins do not appear to work for ARDS,” said Jonathon D. Truwit, MD, professor of medicine and enterprise chief medical officer and senior administrative dean at Froedtert & the Medical College of Wisconsin.

“Observational data suggests that statins reduce mortality in severe sepsis," Dr Truwit said. "Severe sepsis is commonly associated with ARDS. Animal data suggest that statins can prevent ARDS. We hypothesized that statins would reduce mortality and reduce time on breathing machines in sepsis associated ARDS, which is 1 in 4. They did not.”
 

Despite previously-reported observational and basic science evidence suggesting the use of statins may improve outcomes in patients with sepsis and ARDS, a double-blinded clinical trial of rosuvastatin in those patients was futile, and the study was stopped.

In this study, patients received either the rosuvastatin or a placebo. After 745 of the proposed 1,000 patients had been enrolled in the multicenter 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.

“Observational data showed a strong signal favoring big reduction in mortality-related to statin use,” Dr Truwit said. “We did not see this, and may have seen harm.” 

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.