NUI Galway researchers have been part of a large-scale clinical trial of statin treatment in patients with Acute Respiratory Distress Syndrome (ARDS) which was published this week in the New England Journal of Medicine (NEJM).

This international, multi-centre study, led by the Irish Critical Care Trials group, was carried out in over 40 Intensive Care Units across Ireland and the United Kingdom. It was funded by the UK’s Efficacy and Mechanism Evaluation programme (a Medical Research Council and National Institute for Health Research partnership) and by Ireland’s Health Research Board. This four-year project tested the efficacy of the drug simvastatin in 540 patients with ARDS.

ARDS is a devastating condition that occurs in patients with critical illnesses such as severe infections or following severe injuries. The primary condition triggers an uncontrolled inflammatory response which in turn damages the lining of the lungs causing them to fill with fluid. Patients with ARDS are unable to breathe on their own and require artificial ventilation. There is currently no effective treatment for the condition, and about 25% of patients with ARDS die of the combined effects of the lung inflammation and the primary condition.

Observational and early stage research strongly suggested that statins, drugs widely prescribed to lower cholesterol levels in the blood in order to prevent strokes and heart attacks, might also reduce the inflammatory response to critical illnesses and so might reduce the severity of ARDS. Statins are cheap, generally safe drugs with few side effects which, if the early research translated into a benefit in clinical practice, would be rapidly adopted to treat ARDS.

The study (Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction (HARP-2)) was led by Professor Danny McAuley from Queen’s University Belfast and the Belfast Health and Social Care Trust. Professor John Laffey was chief investigator for Ireland. The Northern Ireland Clinical Trials Unit coordinated the overall trial. NUI Galway was the study sponsor in Ireland, while the Galway HRB Clinical research facility study played a key role in the conduct of the study in the Irish centres.

Results showed that while simvastatin was safe and well tolerated, it did not decrease the duration of artificial ventilation or the number of patients who died whilst in hospital with ARDS. According to Professor John Laffey, “While statin therapy demonstrate considerable promise for ARDS in early phase clinical  studies, unfortunately our study  shows that simvastatin does not result in better outcomes for patients with this devastating disease.”

According to Graham Love, Chief Executive of the Health Research Board: "Health research is not just about always finding new treatments. Sometimes it is just as important to rule something out as it is to rule it in. It is very encouraging to see one of the HRB's investments in clinical research infrastructure play such an important role in this study. The HRB Clinical Research Facility in Galway has enabled Irish researchers to collaborate internationally and contribute to significant clinical findings, as evidenced by this research being published in such a renowned medical journal.”

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