April 28, 2006

Steroids not effective against ARDS: study

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Gordon Bernard, M.D.

Steroids not effective against ARDS: study

Art Wheeler, M.D.

Art Wheeler, M.D.

There has been a longstanding belief that the use of corticosteroids in patients with acute respiratory distress syndrome (ARDS) improves survival, but a study in last week's New England Journal of Medicine debunks that theory.

Conducted by ARDS Clinical Research Network institutions across the country, including Vanderbilt University Medical Center, the study reports that steroids should not be the standard therapy for acute lung injury patients.

“This was a very common practice, but it was never shown as beneficial,” said Art Wheeler, M.D., associate professor of Medicine. “Even though our study did not show an improvement in survival, it did show that steroids for a brief period of time improved patient appearance and patients were able to wean off ventilators faster.

“It looks like steroids temporarily improve physiological variables, but they don't change the ultimate outcome of the disease.”

The numbers suggest that 25 percent to 30 percent of patients in the United States were receiving this form of treatment, said Wheeler.

The study, the largest trial of steroids in patients with acute lung injury, used data from 25 centers and 180 patients over a 10-year period. ARDS is a life-threatening lung condition that develops in patients who are critically ill or who have injuries that result in severe fluid buildup in both lungs. It is estimated that between 30 percent to 50 percent of these patients die.

Wheeler, who served as Vanderbilt's co-investigator along with Gordon Bernard, M.D., discovered that the same medication that offers some physiological benefit in early diagnosis also led to other problems, including muscle weakness.

“This has long been a controversial matter,” said Wheeler. “It's a double-edged sword; here's a drug that may work for a while, but risk of complications was significantly higher and there is no net improvement for survival.

“There are many therapies being used around the country that have not been adequately studied and many will be surprised at the results when these (treatments) are finally examined.”

The study was funded by the ARDS Clinical Research Network of the National Heart, Lung and Blood Institute, part of the National Institutes of Health. The multi-center, randomized trial was the first of its kind to look at the effects of steroids in ARDS patients when treatment was started seven days or more after the onset of symptoms.

“The use of steroids in ARDS has been very common over the last quarter of a century and the amount of data to support that use has been very limited,” said Bernard, assistant vice chancellor of Research, medical director of VUMC's Institutional Review Board and chair of the Steering Committee for the NHLBI ARDS Clinical Research Network. “Now we have a study that gives us much better information about what to do with these patients.

“We have an obligation in medicine to use treatments that make sense until we have proof that they do not work. We had concepts that made sense, but we needed to do studies.”

Bernard said with the increasing number of ARDS patients on ventilators, as well as the number of new cases approaching 200,000 each year, it was time to look into a treatment to improve survival.

The study also allowed researchers to identify a group of patients who can be harmed by the treatment and highlights the other therapies that have been proven to assist in survival rates, including lower tidal volume ventilation.

“Thirty years ago the death rate from this disease was approaching 80 percent,” said Wheeler. “Now through the work of the ARDS Network and others, the mortality rate in clinical trials is typically approaching 25 percent. The improvements in overall medical care can account for that.”