Cedars-Sinai Medical Center

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CME Newsletter - June 2014 (PDF)


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Drugs Show Progress Against Fatal Lung Disease

Researchers in separate clinical trials found two drugs slow the progression of idiopathic pulmonary fibrosis (IPF), a fatal lung disease with no effective treatment or cure, and for which there is currently no therapy approved by the federal Food and Drug Administration.

Paul W. Noble, MD, chair of the Cedars-Sinai Department of Medicine and director of the Women's Guild Lung Institute, is the senior author of the multicenter study that found that the investigational drug pirfenidone significantly slowed the loss of lung function and reduced the risk of death. Pirfenidone was developed by InterMune Inc. and in 2011 was approved by the European Union for the treatment of idiopathic pulmonary fibrosis.

The findings of the ASCEND drug trial were published online by the New England Journal of Medicine and were presented last month at the International Conference of the American Thoracic Society in San Diego. "What we discovered about the anti-inflammatory and anti-fibrotic properties of pirfenidone offers help and encouragement to so many patients suffering from this relentless disease that robs them of breath and life," Noble said.

Idiopathic pulmonary fibrosis causes thickening and scarring in the regions of the lungs where oxygen gets to the blood, leaving patients with shortness of breath, a chronic cough and extreme fatigue. Most patients die within two to five years of diagnosis.

"Not only did pirfenidone prevent the loss of lung function and preserve the distance patients could walk, but during the study, the risk of death was reduced by a remarkable 48 percent in those taking the drug when compared with those who received placebo," Noble said. "The findings were so strong that an early access program has been initiated to provide patients with pirfenidone while the process of obtaining FDA approval is undertaken. Cedars-Sinai will be participating in this program under the direction of Dr. Jeremy Falk and the Advanced Lung Disease Program."

Noble also was a co-author of a second study testing the efficacy and safety of the multikinase inhibitor nintedanib on patients with idiopathic pulmonary fibrosis. Nintedanib also is being studied in lung cancer.

"In our research, we found that nintedanib could also slow the loss of lung function in patients with idiopathic pulmonary fibrosis," Noble said. "It is a second dose of good news for our patients because nintedanib not only slowed the progression of the disease, but it tended to reduce acute exacerbations of the disease, while tending to preserve the quality of life of the study patients receiving the drug."

Findings of the nintedanib study also were published online by the New England Journal of Medicine.

Noble is a paid consultant of InterMune Inc. and Boehringer-Ingelheim for his work on the steering committees of the two clinical trials. Cedars-Sinai was not among the medical centers participating in this multicenter study of the drug's efficacy in treating idiopathic pulmonary fibrosis.

"These IPF drug therapy findings by Dr. Noble and his colleagues exemplify the dedication and hard work required to find treatments for a group of patients who have so few therapeutic options because there have been no drugs approved by the Food and Drug Administration specifically targeted for treating this fatal disease," said Shlomo Melmed, MD, senior vice president of Academic Affairs and dean of the medical faculty at Cedars-Sinai.