Simvastatin in the Acute Respiratory Distress Syndrome.
Background: There are in vitro, animal and phase 2 studies suggesting that statins may be beneficial in the acute respiratory distress syndrome (ARDS) This study tested the hypothesis that treatment with simvastatin would improve clinical outcomes in patients with ARDS. Methods: In this multicentre, allocation concealed, double blind clinical trial, patients with an onset of ARDS within the previous 48 hours were randomized in a 1:1 ratio to receive enteral simvastatin 80mg or placebo once daily for a maximum of 28 days. The primary outcome was the number of ventilator free days to day 28. Secondary outcomes included number of non pulmonary organ failure free days to day 28, mortality at 28 days and safety. Results: The study recruited 540 patients with 259 patients allocated to simvastatin and 281 patients to placebo. The groups were well matched with respect to demographic and baseline physiological variables. There was no significant difference between study groups in mean SD) ventilator free days (12.6+ 9.9 with simvastatin and 11.5+ 10.4 with placebo, P 0.21) non pulmonary organ failure free days (19.4+ 11.1 with simvastatin and 17.8+ 11.7 with placebo, P 0.11) or in 28 day mortality (22.0% with simvastatin and 26.8% with placebo, P 0.23) There was no difference in the incidence of severe adverse events between the groups. Conclusions: Simvastatin therapy, while safe and with minimal adverse effects, did not improve clinical outcomes in patients with ARDS. (Funded by the UK National Institute for Health Research Efficacy and Confidential: Destroy when review is complete. Submitted to the New England Journal of Medicine
The New England journal of medicine