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Statin drugs safe but ineffective in the treatment of Acute Respiratory Distress Syndrome, research finds

Toronto, September 30, 2014

By Leslie Shepherd

Dr. John Laffey points to a screen with an X-ray of lungs
Dr. John Laffey

Cholesterol-lowering drugs known as statins are safe to give to patients with Acute Respiratory Distress Syndrome, but they do not reduce the number of patients who die while in hospital or the length of time they spend on mechanical ventilation, new research has found.

ARDS is an often fatal condition that occurs in in patients with critical illnesses such as severe infections or following severe injuries. An uncontrolled inflammatory response damages the lining of the lungs causing fluid to build up in the tiny, elastic air sacs in the lungs known as alveoli, reducing the amount of oxygen that reaches the bloodstream. Patients with ARDS are unable to breathe on their own and require artificial ventilation.

There is no effective treatment for ARDS and about 25 per cent of patients die of the combined effects of the lung inflammation and their primary illness or injury.

Researchers, including Dr. John Laffey of St. Michael’s Hospital, wondered whether statins, drugs widely prescribed to lower cholesterol levels in the blood to prevent strokes and heart attacks, might also reduce the inflammatory response to critical illnesses and thereby reduce the severity of ARDS. Statins are cheap, generally safe drugs with few side effects.

The results of a four-year clinical trial of the drug simvastatin in patients with ARDS were published today in the New England Journal of Medicine. This study, led by Professor Danny McAuley from The Queen’s University Belfast and the Belfast Health and Social Care Trust, was carried out in more than 40 Intensive Care Units across Ireland and the United Kingdom and involved 540 patients. Dr. Laffey, the chief anaesthesiologist at St. Michael’s and a researcher in the hospital’s Keenan Research Centre for Biomedical Science, was the chief investigator for Ireland.

The study found that while simvastatin was safe and well tolerated, it did not decrease the duration of artificial ventilation or the number of patients who died while in hospital with ARDS.

“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 devastating disease,” Dr Laffey said.

About St. Michael's Hospital

St. Michael’s Hospital provides compassionate care to all who enter its doors. The hospital also provides outstanding medical education to future health care professionals in 27 academic disciplines. Critical care and trauma, heart disease, neurosurgery, diabetes, cancer care, care of the homeless and global health are among the hospital’s recognized areas of expertise. Through the Keenan Research Centre and the Li Ka Shing International Healthcare Education Centre, which make up the Li Ka Shing Knowledge Institute, research and education at St. Michael's Hospital are recognized and make an impact around the world. Founded in 1892, the hospital is fully affiliated with the University of Toronto.

Media contacts

For more information, or to arrange an interview with Dr. Laffey, contact:

Leslie Shepherd
Manager, Media Strategy
416-864-6094
shepherdl@smh.ca

Note to editors:

1. The project is managed by the Efficacy and Mechanism Evaluation Programme, an MRC and NIHR partnership, that supports later-phase “science-driven” clinical trials and evaluative studies, which seek to determine whether a health intervention (e.g. a drug, diagnostic technique or device) works and in some cases how or why it works. The programme is funded by the MRC and NIHR, with contributions from the CSO in Scotland, NISCHR in Wales and the HSC R&D Division, Public Health Agency in Northern Ireland. www.nets.nihr.ac.uk/programmes/eme

2. The National Institute for Health Research (NIHR) is funded by the Department of Health to improve the health and wealth of the nation through research. Since its establishment in April 2006, the NIHR has transformed research in the NHS. It has increased the volume of applied health research for the benefit of patients and the public, driven faster translation of basic science discoveries into tangible benefits for patients and the economy, and developed and supported the people who conduct and contribute to applied health research. The NIHR plays a key role in the Government’s strategy for economic growth, attracting investment by the life-sciences industries through its world-class infrastructure for health research. Together, the NIHR people, programmes, centres of excellence and systems represent the most integrated health research system in the world. For further information, visit the NIHR website (www.nihr.ac.uk).

3. The Medical Research Council has been at the forefront of scientific discovery to improve human health. Founded in 1913 to tackle tuberculosis, the MRC now invests taxpayers’ money in some of the best medical research in the world across every area of health. Twenty-nine MRC-funded researchers have won Nobel prizes in a wide range of disciplines, and MRC scientists have been behind such diverse discoveries as vitamins, the structure of DNA and the link between smoking and cancer, as well as achievements such as pioneering the use of randomised controlled trials, the invention of MRI scanning, and the development of a group of antibodies used in the making of some of the most successful drugs ever developed. Today, MRC-funded scientists tackle some of the greatest health problems facing humanity in the 21st century, from the rising tide of chronic diseases associated with ageing to the threats posed by rapidly mutating micro-organisms. www.mrc.ac.uk

The views expressed in this publication are those of the author(s) and not necessarily those of the MRC, NIHR, the National Health Service or the Department of Health (UK).