Simvastatin did not improve clinical outcomes in adults with respiratory distress syndrome, compared with placebo, according to investigators.
The report was published online Sept. 30 in the New England Journal of Medicine.
Despite positive findings in early-phase studies, large clinical trials have failed to show that statins benefit patients with ARDS, said Dr. Daniel McAuley of Queen’s University of Belfast, Ireland, and his associates. The earlier studies used surrogate measures that do not clearly correlate with patient-specific outcomes, the researchers said. “Surrogate outcomes that more closely track patient outcomes need to be identified,” they added (N. Engl. J. Med. 2014 Sept. 30 [doi: 10.1056/NEJMoa1403285]).
The multicenter, double-blind trial comprised 540 adults with ARDS from 40 intensive care units in the United Kingdom and Ireland. Patients were randomized to enteral simvastatin or placebo, and the groups did not differ significantly in terms of number of ventilator-free days (12.6 vs. 11.5 days, respectively), days free of nonpulmonary organ failure (19.4 vs. 17.8 days), or 28-day mortality (22% vs. 26.8%), the investigators reported. Adverse effects also were similar between the groups, they said.
The researchers recruited a heterogeneous cohort of patients with ARDS resulting from any cause so that findings would be generalizable, they wrote. Because recent research suggests that identification of specific phenotypes within ARDS may be possible, future studies “may identify a subpopulation of patients with ARDS who might have a greater response to simvastatin than was observed in our study,” they noted.
The study was funded by the U.K. Efficacy and Mechanism Evaluation Programme, a joint partnership of the Medical Research Council and the National Institute for Health Research. Dr. McAuley reported financial ties to GlaxoSmithKline as well as a patent pending application related to a novel treatment for ARDS.