Drug May Ease Progressive Lung Disease

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Drug May Ease Progressive Lung Disease

Researchers Say Roflumilast Improved Lung Function and Quality of Life

for People With COPD

By Miranda Hitti

WebMD Medical News Reviewed By Brunilda Nazario, MD

on Friday, August 12, 2005

Aug. 12, 2005 -- A drug available in Europe called roflumilast helps

ease symptoms of chronic obstructive pulmonary disease (COPD),

researchers report in The Lancet.

COPD is an inflammatory airway disease with progressive decline in lung

function and health-related quality of life.

In an international study of more than 1,100 patients with COPD, those

taking roflumilast had bigger improvements in their lung function and

quality of life than those taking a fake drug (placebo).

Roflumilast is a promising candidate for treatment of the lung disease

because it improved lung function and reduced exacerbations of symptoms

compared with placebo, write the researchers.

The study was sponsored by Altana Pharma AG, roflumilast's maker. The

company also managed the data and did all the final analyses, write the

researchers.

About COPD

COPD is the No. 5 cause of death worldwide, write the researchers. They

included professor Klaus Rabe, MD, of Leiden University Medical Centre

in the Netherlands.

Cases of COPD are rising and treatment options are " limited, " write the

researchers. They note predictions that COPD -- which causes

progressive worsening of breathing and destruction of the lungs -- will

be the world's No. 3 cause of death by 2020.

" The disease is usually related to cigarette smoking, but other

[causes], such as exposure to air pollution, exist, " write Rabe and

colleagues.

Treatments include therapy targeted at smoking cessation, medications

to improve airway obstruction (bronchodilators), and anti-inflammatory

steroid drugs.

Steroids do not reduce the progression of the disease, they write.

Bronchodilators provide some symptom relief, but there is a definite

unmet medical need that specifically targets inflammation associated

with COPD, they add.

New Study

New Study

Roflumilast is designed to soothe inflammation. It's part of a class of

drugs called phosphodiesterase-4 inhibitors, which inhibit a particular

chemical in inflammatory cells that cause progressive lung tissue

destruction.

The new study was conducted in 11 countries. Participants were all at

least 40 years old, had had COPD for more than a year, and were current

or ex-smokers. None had asthma, lung cancer, or other lung diseases in

addition to COPD.

Participants were randomly assigned to take roflumilast or the placebo

orally once daily for 24 weeks. They didn't know which treatment they

got.

Study's Results

Patients taking roflumilast had significantly bigger improvements in

lung function and health-related quality of life than those taking the

placebo, write the researchers.

Two daily doses of roflumilast were tested (250 or 500 milligrams).

Both doses had similar quality-of-life results, the study shows.

Some COPD flare-ups ( " exacerbations " ) happened in each group. There

were fewer exacerbations with roflumilast than with the placebo. Those

taking the higher dose of roflumilast had the fewest exacerbations,

write the researchers.

Side Effects

Diarrhea was the most common side effect associated with roflumilast.

It was reported by 13 people taking the drug's low dose (2%), 34

patients taking the higher dose (6%), and none of those taking the

placebo.

Nausea was the second most common side effect linked to the drug.

Headaches were reported by a few people in each group (4%) and probably

weren't due to roflumilast, write the researchers.

SOURCES: Rabe, K. The Lancet, Aug. 13, 2005; vol 366: pp 563-571. News

release, The Lancet.

http://my.webmd.com/content/Article/110/109503.htm?

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