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Advair Won't Lower COPD Death Risk: Study


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For this study, the researchers recruited people with COPD from 444 centers in 42 different countries. The study participants were between 40 and 80 years old and were current or former smokers with at least a 10-year, pack-a-day smoking history.

More than 6,100 people were randomized into one of the four treatment groups for three years. The dose of salmeterol was 50 micrograms and the fluticasone propionate was given at a dose of 500 micrograms.

When the researchers looked at all-cause death rates, they found no statistically significant difference between the four groups. The all-cause mortality rate was 12.6 percent for the combination (Advair) group, 15.2 percent in the placebo group, 13.5 percent in the salmeterol alone group and 16 percent in the fluticasone propionate group.

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There was some good news for those on combination therapy, however. Use of Advair reduced the number of annual exacerbations to 0.85 compared to 1.13 in the placebo group. Additionally, lung function and overall health status were improved in the combination therapy group compared to placebo.

Calverley said he wasn't sure why the combination therapy didn't affect the mortality rate when it seemed to improve overall health. He and the other authors suggested that the high drop-out rate -- 40 percent -- in the placebo group might have affected the mortality outcomes.

The researchers also looked for specific side effects, such as a possible increase in eye disorders such as cataracts, or a decrease in bone density, both of which are known side effects of long-term steroids taken orally rather than inhaled. They found no such problems with the inhaled form of steroids. There was, however, an increased risk of pneumonia in people taking combination therapy or in people using fluticasone alone.

"This [finding] was unanticipated and did not translate into an increase in the number of people dying from pneumonia," said Calverley.

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Copyright © 2007 ScoutNews, LLC. All rights reserved.
Last updated 2/22/2007

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SOURCES: Peter M.A. Calverley, M.D., professor, respiratory medicine, University of Liverpool and University Hospital Aintree, Liverpool, U.K.; Klaus Rabe, M.D., Ph.D., chairman, department of pulmonology, and professor of medicine, Leiden University Medical Center, Leiden, the Netherlands; Bohdan Pichurko, M.D., chief, pulmonology, Providence Hospital, Southfield, Mich.; Feb. 22, 2007, New England Journal of Medicine; Feb. 19, 2007, early online edition, Annals of Internal Medicine


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