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【medical-news】Advair 对COPD 死亡率无降低但可改善
The steroid-plus-bronchodilator does improve patients' quality of life, however
HealthDay
Thursday, February 22, 2007
THURSDAY, Feb. 22 (HealthDay News) -- Using Advair, an inhaled steroid combined with a long-acting bronchodilator, does not prolong the lives of patients with chronic obstructive pulmonary disease (COPD), but it could improve their quality of life by making breathing easier.
That's the conclusion from a large international trial that compared four different treatments in people with the progressive, debilitating lung disease.
The study compared the use of the long-acting bronchodilator salmeterol alone, the inhaled steroid fluticasone propionate alone, salmeterol plus fluticasone in combination (sold as Advair in the United States), or a placebo.
"There were no significant differences in mortality between the component drugs and the placebo treatment," said the study's lead author, Dr. Peter M.A. Calverley, a professor of respiratory medicine at the University of Liverpool and University Hospital Aintree. However, he did note a 25 percent decline in the total number of exacerbations for patients taking Advair compared to placebo, "and this was also statistically significant, better than either of the component drugs [alone]."
Results of the study, which was funded by drug manufacturer GlaxoSmithKline, are published in the Feb. 22 issue of the New England Journal of Medicine. GlaxoSmithKline sells combination salmeterol-plus-fluticasone therapy under the brand name Advair in the United States and as Seretide in the rest of the world.
COPD, a lethal combination of emphysema and chronic bronchitis, is responsible for 2.75 million deaths worldwide, according to background information in the study. Most cases of COPD -- between 80 percent and 90 percent -- are caused by smoking, according to the American Lung Association. There are few effective treatments for COPD, and most treatments cannot reduce the rates of mortality, according to the study.
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.
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.
"I am surprised, and I am worried [about the pneumonia findings]," said the author of an accompanying editorial in the same issue of the journal, Dr. Klaus Rabe, chairman of the department of pulmonology at Leiden University Medical Center in the Netherlands.
In his editorial, Rabe wrote that "caution in the use of combination therapy is urged because of the finding in [this] trial of an increased rate of pneumonia among all patients receiving treatment containing inhaled corticosteroids."
On the other hand, Dr. Bohdan Pichurko, chief of pulmonology at Providence Hospital in Southfield, Mich., said he was reassured that after three years of treatment, the study found no increased risk of eye or bone problems. Also, there have been some studies questioning the safety of salmeterol, but, in this population, the drug appears to be safe.
"With the exception of minor oral-comfort issues and this peculiar increase in pneumonia, this combination seems to be safe and to offer significant benefits. While the endpoint of all-cause mortality is interesting, what's immensely important to patients is that there's some improvement in airway function and improved overall health status," said Pichurko.
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作者:admin@医学,生命科学 2011-02-17 18:05
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