Beeing involved in this multicenter, double-blind trial myself I am honoured to announce the Harp-2's publication in the New England Journal of Medicine. Congratulations not only to John Laffey but also to Michael Scully who kept Galway going in the recruitment of patients for this trial.
In the past several publications have shown a beneficial effect of statins in the process of lung inflammation and injury. So far though none of these studies was designed or powered to show the effect of statins on clinical outcomes. The aim of this trial was therefore to see whether 80mg of daily simvastatin would improve clinical outcomes in patients with ARDS.
For this study 40 intensive care units in Ireland and the United Kingdom (the ICU at the Galway University Hospital being one of them) randomised a total of 540 patients to receive either simvastatin 80mg OD or placebo. Primary outcome was defined as the number of ventilator-free days to day 28. Secondary outcomes included: change in the oxygenation index and the SOFA score up to day 28, the number of days free of non pulmonary organ failure to day 28, death from any cause within 28 days, death before discharge from ICU or the hospital, and safety.
As a result there were no differences in any of the outcomes mentioned. As the authors mention in the discussion themselves:
The use of simvastatin in the management of ARDS cannot be supported.
McAuley et al. September 30, 2014DOI: 10.1056/NEJMoa1403285