TUESDAY, Sept. 30, 2014 (HealthDay News) -- For patients with acute respiratory distress syndrome (ARDS), simvastatin does not improve clinical outcomes, according to a study published online Sept. 30 in the New England Journal of Medicine. The research was published to coincide with the annual meeting of the European Society of Intensive Care Medicine, held from Sept. 27 to Oct. 1 in Barcelona, Spain.
Daniel F. McAuley, M.D., from the Queen's University of Belfast in the United Kingdom, and colleagues conducted a multicenter double-blind clinical trial involving 540 patients with an onset of ARDS within the previous 48 hours. Participants were randomized to receive 80 mg enteral simvastatin (259 patients) or placebo (281 patients) once daily for a maximum of 28 days.
The researchers observed no significant between-group differences in the mean number of ventilator-free days (12.6 ± 9.9 and 11.5 ± 10.4 with simvastatin and placebo, respectively; P = 0.21); the number of days free of nonpulmonary organ failure (19.4 ± 11.1 and 17.8 ± 11.7, respectively; P = 0.11); or 28-day mortality (22.0 and 26.8 percent, respectively; P = 0.23). The incidence of serious adverse events related to the study drug did not differ significantly between the groups.
"Simvastatin therapy, although safe and associated with minimal adverse effects, did not improve clinical outcomes in patients with ARDS," the authors write.