Genetic Profile
RESEARCH TRIANGLE PARK, N.C. and PHILADELPHIA, March 16 /PRNewswire/ --
Data presented today by GlaxoSmithKline showed that genetic differences at
the site of the beta-2 adrenergic receptor gene in asthma patients did not
lead to different responses to Advair Diskus(R) (fluticasone propionate and
salmeterol inhalation powder) or Serevent Diskus(R) (salmeterol xinofoate
inhalation powder).
Past prospective clinical trials have found that the use of
short-acting beta-agonists, such as albuterol, were linked to worse
outcomes in patients with asthma with the Arg/Arg genotype of the beta-2
adrenergic receptor gene. In the research presented today, those patients
with the Arg/Arg profile responded to Advair (the combination of an inhaled
corticosteroid and a long-acting beta-agonist) or Serevent (a long-acting
beta-agonist) treatment as well as those patients with the two other forms
of the gene (Arg/Gly and Gly/Gly).
The data (abstract #554) was presented by Eugene R. Bleecker, M.D., a
professor of medicine and co-director of the Center for Human Genomics at
the Wake Forest University School of Medicine at the 2008 American Academy
of Allergy, Asthma and Immunology annual meeting in Philadelphia.
"This study was the largest prospective study of the impact of genetic
differences in the beta-2 adrenergic receptor on response to asthma
therapy, and we were encouraged to see that patients with the Arg/Arg gene
variation responded to Advair and Serevent therapy just as well as patients
without that variation," said Dr. Bleecker. "This study is a large step
forward in furthering our knowledge of the interplay between genetics and
therapy in asthma."
The 544-patient trial evaluated three groups of patients: those with
the Arg/Arg genotype, those with the Arg/Gly genotype and those with the
Gly/Gly genotype. Patients were treated for 16 weeks with either Advair or
Serevent.
The results showed that there was no significant difference between any
of the three genotype groups for the primary endpoint, morning peak
expiratory flow rate, and all genotype groups showed sustained improvement
on treatment with Advair or Serevent. There was also no difference between
the improvement recorded for each of the three groups on the secondary
endpoints of forced expiratory volume in 1 second (FEV1), symptom-free days
or use of a rescue inhaler.
A sub-analysis of that trial was also presented today at the AAAAI
meeting (abstract #509) by Harold Nelson, M.D., professor of medicine at
National Jewish medical and Research Center in Denver. Dr. Nelson's
analysis found that the incidence of asthma exacerbations, defined as
worsening asthma requiring ED-visit/hospitalization or any medication
beyond protocol, did not differ by genetic profile, further suggesting that
having a genetic variation in the beta-2 adrenergic receptor does not have
an effect on response to Advair or Serevent.
Further research on the same group of patients (abstract #552) was also
presented, examining more closely any link between genetic differences in
the beta-2 adrenergic receptor gene and response to therapy. That trial
looked at 11 different genetic polymorphisms or haplotypes on that gene and
found that no single variation was associated with a differential response
to Advair or Serevent.
Advair Diskus combines two medications in one device to help prevent
and control asthma symptoms. Asthma causes inflammation (swelling in the
airways) and airway constriction (the tightening of muscles that surround
the airways), and Advair contains both an inhaled corticosteroid,
fluticasone propionate, to reduce inflammation; and an inhaled long-acting
bronchodilator, salmeterol, to help prevent and reduce airway constriction.
Advair is for people who still have symptoms on another asthma controller,
or whose disease severity clearly warrants treatment with two maintenance
therapies.
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.
Important information about Serevent Diskus
Serevent Diskus does not replace fast-acting inhalers for sudden
symptoms and should not be taken more than twice a day. In patients with
asthma, medicines like Serevent may increase the chance of asthma-related
death. People should talk to their doctor about this risk and the benefits
of treating their asthma with Serevent Diskus.
Serevent Diskus should not be the only controller medicine prescribed
for a person's asthma and is not a substitute for anti-inflammatory
medications (inhaled or oral corticosteroids). 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. People should see their doctor if their asthma does not improve.
Serevent Diskus is indicated for the long-term, twice-daily (morning
and evening) administration in the maintenance treatment of asthma in
patients 4 years of age and older. Serevent Diskus is also indicated for
the prevention of exercise-induced bronchospasm in patients 4 years of age
and older. Serevent Diskus is indicated for the maintenance treatment of
bronchospasm associated with chronic obstructive pulmonary disease (COPD)
(including emphysema and chronic bronchitis).
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based
pharmaceutical and healthcare companies. GlaxoSmithKline is committed to
improving the quality of human life by enabling people to do more, feel
better and live longer. For company information visit http://www.gsk.com.
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