Drug does little to cut lung disease death rate

BOSTON (Reuters) - A combination of two GlaxoSmithKline drugs may help keep patients with emphysema and chronic bronchitis from suffering severe complications, researchers reported on Wednesday.

The company already had reported that the combination -- known as Advair in the United States, Viana in Germany and Seretide in the rest of the European Union -- did not significantly cut the rate of death for the two diseases, known jointly as chronic obstructive pulmonary disease or COPD.

The report in the New England Journal of Medicine added details from the study and shed light on which drugs can and cannot help patients with COPD.

COPD is the fourth leading cause of death in the United States, killing more people than breast and lung cancer combined. Smoking is the biggest cause.

A research team led by Dr. Peter Calverley of University Hospital Aintree in Liverpool, Britain, studied 6,112 volunteers at 444 medical centers in 42 countries.

After three years of treatment, 12.6 percent of the patients given the combination of Serevent and Flovent died compared to 15.2 percent who got a placebo, a difference so small it could be due to chance.

"The reduction in mortality in the combined-therapy group did not reach the predetermined level of statistical significance," Dr. Klaus Rabe of Leiden University Medical Center in the Netherlands wrote in a commentary in the journal.

"Believe it or not, we still need more data, from even larger trials."

GlaxoSmithKline reported that Advair reduced the risk of death by 17.5 percent.

"Seretide, when compared with placebo, also showed a 25 percent reduction in the rate of exacerbations, which are a worsening of the patient's condition often causing increased difficulty in breathing," Glaxo said in a statement.

"Exacerbations are a major cause of hospitalization and have significant physical and psychological effects on patients, many of whom never fully recover from the impact."

It said it had sought permission to add this finding to its labeling.

GlaxoSmithKline paid for the study. All of its eight listed authors were either employees of the pharmaceutical giant or had financial ties to the company.

The researchers speculated that Advair may not have reduced the death rate because dying from COPD may be influenced by factors doctors do not recognize. Rabe pointed out that 40 percent of the patients originally in the trial dropped out, making it difficult to get good results.

They also contended that it is more likely that the study was not large enough to show the combination could reduce the death rate. In addition to the 1,533 who received Advair and 1,524 who inhaled placebo, 1,534 took fluticasone alone and 1,521 only got salmeterol, a type of drug known as a beta agonist.

The study was, however, big enough to show that the steroid drug fluticasone by itself, or in combination with salmeterol, increased the risk of pneumonia.

Rabe said it was clear that taking a beta agonist like salmeterol was safe but that no one with COPD should take a steroid such as fluticasone by itself.

Currently, the only treatments known to reduce the death rate in patients COPD are oxygen therapy, smoking cessation and surgery to remove lung tissue.

The company has been selling more than $5 billion worth of Advair each year. The European patent on the combination runs out next year. It will expire in the United States in 2010.