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Study links pneumonia to two asthma inhalers

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BY RICHARD CRAVER

MEDIA GENERAL NEWS SERVICE

Published: February 18, 2009

WINSTON-SALEM, N.C. - Two popular anti-inflammatory inhalers may significantly increase the risk of pneumonia for the 16 million Americans affected by chronic obstructive pulmonary disease, a new study found.

The study found an increase of up to 70 percent in cases of pneumonia in patients who used inhaled corticosteroid drugs, either alone or in combination with other drugs, for at least 24 weeks. There were nearly 17,000 patients included in the 18 clinical trials in the study by researchers at Wake Forest University School of Medicine. The report appeared last week in Archives of Internal Medicine.

The researchers said that the available inhaled-steroid combinations are Advair, marketed by GlaxoSmithKline, and Symbicort, marketed by AstraZeneca. Advair is GlaxoSmithKline's top-selling drug, with U.S. sales exceeding $3 billion last year.

"Clinicians should revaluate the benefit-harm profile of long-term inhaled corticosteroid use among patients with COPD," said Dr. Sonal Singh, the lead researcher of the study.
Chronic obstructive pulmonary disease makes it hard for patients to breathe. It can cause production of large amounts of mucus that leads to coughing, wheezing, shortness of breath, chest tightness and other symptoms.

The researchers said that cigarette smoking is the leading cause of the disease, and most people who have it smoke or are former smokers. Long-term exposure to other lung irritants, such as air pollution, chemical fumes or dust, also may contribute to the disease.

The disease is the fourth-leading cause of death in the United States, accounting for more than 120,000 deaths annually and resulting in more than $30 billion in health-care costs each year, according to the National Lung Health Education Program.

The researchers, however, did not find a "significantly increased risk of death" from using the inhaled corticosteroid drugs.

The researchers said that because the number of people with the disease is rising rapidly, and it often goes undiagnosed, the number of Americans affected could be as high as 24 million.

Researchers caution that these results pertain specifically to patients with the disease, rather than asthma patients. They recommend that "clinicians should remain vigilant for the development of pneumonia with inhaled corticosteroids, as the signs and symptoms of pneumonia may closely mimic that of COPD exacerbations."

Both analysts and GlaxoSmithKline representatives said that the benefits and risks of using the drugs need to be weighed by doctors.

Patty Johnson, a product-communications manager for GlaxoSmithKline, said that the company already has a warning label with Advair because of its own studies on the drug.

"The benefits of Advair are well established in providing significant improvement of lung function," Johnson said. "We believe there is a role for Advair in the treatment of COPD."

The study "certainly should be a warning to doctors treating COPD patients that they are at increasing risk of pneumonia if they are prescribing these steroids," said Dr. Thomas Croxton, the branch chief for the division of lung diseases at the National Heart Lung and Blood Institute.

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