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Updated Monday, December 31, 2007 0:00 am TWN, Bloomberg

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Drug lowers death risk in smoker’s cough, study says

LONDON -- GlaxoSmithKline Plc’s Advair Diskus inhaler cut the risk of death in people with a lung condition caused by smoking more than Boehringer Ingelheim GmbH’s Spiriva HandiHaler, according to a new study.

Patients with smoker’s cough who used the highest dose of Advair were 52 percent less likely to die over a two-year period compared with those on Spiriva, the Glaxo-sponsored study published in the American Journal of Respiratory and Critical Care Medicine showed.

Glaxo is trying to extend use of the top-selling Advair, which is also prescribed to treat asthma, as growth in sales of the inhaler slows. Friday’s study showed that patients using Advair had more improvement in quality of life than those given Spiriva. The rate at which symptoms of the ailment, known as chronic obstructive pulmonary disease, worsened was similar.

“There is no cure for COPD, so we must manage the disease as effectively as possible to provide patients with the best outcomes,” Wisia Wedzicha, a professor of respiratory medicine at University College London, said in a statement from London- based Glaxo.

European regulators approved the higher dose of Advair, which combines 500 micrograms of fluticasone propionate powder and 50 micrograms of salmeterol powder, for severe COPD in 2003. The product brought in 6.13 billion pounds (US$12.2 billion) for Glaxo, the world’s second-largest drugmaker, in 2006, an increase of about 12 percent from a year earlier.

The U.S. Food and Drug Administration rejected the drugmaker’s application to sell the higher dose of the inhaler for the disease in August, questioning how the highest dose of Advair compared with a medium-strength one. A medium-strength version was cleared in the U.S. for COPD in 2003.

The study enrolled more than 1,300 people in Europe and followed them for two years. It was the first clinical trial to show a clear difference in death risks for two approved COPD treatments, Glaxo said in the statement.

“We’re surprised to see that the mortality has been pushed so much,” said Ute Schmidt, a spokeswoman at Ingelheim, Germany-based Boehringer. “This wasn’t a true mortality trial in that it didn’t follow up all the patients after trial was over.

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