African American
patients with asthma treated with Advair Diskus, a combination of the
long-acting beta-agonist (LABA) salmeterol and the inhaled corticosteroid
(ICS) fluticasone propionate, had a lower rate of exacerbations when
compared with patients who received treatment with the ICS Flovent
Diskus(R) (fluticasone propionate inhalation powder) alone, although the
difference was not statistically significant. Patients in the Advair group
also showed improvements in lung function measures, nighttime awakenings
due to asthma, and reductions in daily symptoms and rescue inhaler use
compared to Flovent. The data was published in the June 2008 issue of
Current Medical Research and Opinion.
This large prospective trial, which followed 475 patients who received
either twice-daily Advair Diskus 100/50 (fluticasone propionate and
salmeterol inhalation powder) or twice-daily Flovent Diskus 100mcg for a
year, was the first prospective study to assess the addition of a LABA to
an ICS compared to ICS alone in African Americans with persistent asthma.
In this study, Advair provided important benefits to patients and no
increased rate of adverse events compared with Flovent in the African
American patient population. The findings of the study also contribute to
the body of evidence which has found that salmeterol (a LABA) is not
associated with an increase in serious asthma-related events when used with
an ICS, but rather provides clinical benefits for patients who require more
than ICS treatment alone to control their asthma.
"Uncontrolled asthma is a critical public health issue for African
Americans, and this research is reassuring for clinicians whose patients
are not controlled on an ICS alone that treatment with Advair helps improve
day-to-day asthma control," said William Bailey, M.D., lead author and
Director of the Lung Health Center at the University of Alabama at
Birmingham. "Preventing exacerbations and improving lung function are
important goals of asthma management."
Current treatment guidelines recommend the addition of a LABA to an ICS
in patients with moderate to severe asthma who are uncontrolled on an ICS
alone. Taken in combination, an ICS and LABA fight the two main components
of asthma -- inflammation (swelling in the airways) and airway constriction
(the tightening of muscles that surround the airways). Inhaled
corticosteroids treat the inflammation, while LABAs treat the airway
constriction. Optimal therapy for many patients with persistent moderate to
severe asthma requires treatment of both these components.
The study was designed to primarily show that Advair improved the rate
of exacerbations compared to Flovent. While Advair patients had a lower
exacerbation rate than those patients in the Flovent group, the difference
was not statistically significant. On most of the secondary endpoints,
patients given Advair performed better than patients who used Flovent.
Forced expiratory volume in one second (FEV1) improved in Advair patients.
Both morning and evening peak expiratory flow (PEF) were also improved in
the Advair group. Patients using Advair were also less likely to awake at
night due to asthma-related breathing difficulties. Additionally, the
Advair group showed reductions in the rate of daily symptoms and the need
for a rescue inhaler.
Both Advair and Flovent were well tolerated. Over a one-year period,
the overall incidence of adverse events was similar between the two groups.
Important Information about Advair Diskus
Advair Diskus won't replace fast-acting inhalers for sudden symptoms
and should not be taken more than twice a day. Advair Diskus contains
salmeterol. In patients with asthma, medicines like salmeterol may increase
the chance of asthma-related death. So Advair Diskus is not for people
whose asthma is well controlled on another controller medicine. People
should speak to their doctor about the risks and benefits of treating their
asthma with Advair Diskus. People taking Advair Diskus should see their
doctor if their asthma does not improve. People should tell their doctor if
they have a heart condition or high blood pressure. Some people may
experience increased blood pressure, heart rate, or changes in heart
rhythm. Advair Diskus is for patients 4 years and older. For patients 4 to
11 years old, Advair Diskus 100/50 is for those who have asthma symptoms
while on an inhaled corticosteroid.
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