COPD on the Rise and Many Don't Recognize the Symptoms
Resources Available to Help Take Control
WILMINGTON, Del., Nov. 11, 2013
WILMINGTON, Del., Nov. 11, 2013 /PRNewswire/ -- For many Americans, breathing
is a challenge. Over 12 million have chronic obstructive pulmonary disease
(COPD) ^ and live with symptoms, including constant coughing, wheezing, and
shortness of breath. But with an additional 12 million Americans remaining
undiagnosed, recognizing COPD signs and symptoms and seeking help is an
important health priority.
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"November is National COPD Awareness Month, so it's a good time to talk about
the need to educate and encourage patients to take control of their COPD
symptoms," said Frank Trudo, MD, Medical Affairs, AstraZeneca. "Since many are
not even aware that they have COPD, it is important for them to check in with
their doctors about their symptoms to ensure proper diagnosis and discuss
available treatment options."
COPD is a serious lung disease that is the third leading cause of death in the
US. COPD can start early, sometimes occurring in people as young as 40 years
old with a history of smoking, ^ and it is a progressive disease in which
signs and symptoms worsen over time.
As part of AstraZeneca's commitment to respiratory disease education, during
National COPD Awareness Month (NYSE: AZN), the company is making resources
available to aidpatients in disease management.
Although there is no cure for COPD, there are FDA-approved treatments,
including SYMBICORT^® (budesonide/formoterol fumarate dihydrate) Inhalation
Aerosol. SYMBICORT, a combination of inhaled corticosteroid and long-acting
beta-adrenergic agonist made by AstraZeneca, is indicated for the
maintenance treatment of airflow obstruction in patients with COPD, including
chronic bronchitis and emphysema. For more information please visit
Please see full Prescribing Information, including Boxed WARNING.
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
Lower respiratory tract infections, including pneumonia, have been reported
following the inhaled administration of corticosteroids.
oIn 2 placebo-controlled SYMBICORT COPD clinical studies, pneumonia did not
occur with greater incidence in the SYMBICORT 160/4.5 group, compared with
placebo, while the incidence of lung infections other than pneumonia (eg,
bronchitis) was higher for SYMBICORT than placebo
SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers
to treat acute symptoms.
It is possible that systemic corticosteroid effects such as hypercorticism and
adrenal suppression may occur, particularly at higher doses. Particular care
is needed for patients who are transferred from systemically active
corticosteroids to inhaled corticosteroids.
Patients who are receiving SYMBICORT should not use additional formoterol or
other LABA for any reason.
Due to possible immunosuppression, potential worsening of infections could
occur. A more serious or even fatal course of chickenpox or measles can occur
in susceptible patients.
Excessive beta-adrenergic stimulation has been associated with central nervous
system and cardiovascular effects. SYMBICORT, like all products containing
sympathomimetic amines, should be used with caution in patients with
convulsive disorders, thyrotoxicosis, and cardiovascular disorders, especially
coronary insufficiency, cardiac arrhythmias, and hypertension. Beta-adrenergic
agonist medications may produce hypokalemia and hyperglycemia in some
patients. As with other inhaled medications, paradoxical bronchospasm may
occur with SYMBICORT. Use with caution in patients with diabetes mellitus.
Long-term use of orally inhaled corticosteroids, such as budesonide, a
component of SYMBICORT, may result in a reduction in growth velocity and/or a
loss of bone mineral density.
Glaucoma, increased intraocular pressure, and cataracts have been reported
following the inhaled administration of corticosteroids, including budesonide,
a component of SYMBICORT.
In rare cases, patients on inhaled corticosteroids may present with systemic
SYMBICORT should be administered with caution to patients being treated with
MAO inhibitors or tricyclic antidepressants, or within 2 weeks of
discontinuation of such agents. Caution should also be exercised in patients
on long-term ketoconazole and other known potent CYP3A4 inhibitors.
The most common adverse eventsgreater than or equal to3% reported in COPD
clinical trials included nasopharyngitis, oral candidiasis, bronchitis,
sinusitis, and upper respiratory tract infection.
WARNING: Long-acting beta-adrenergic agonists (LABA), such as formoterol,
one of the active ingredients in SYMBICORT, increase the risk of
asthma-related death. A placebo-controlled study with another LABA
(salmeterol) showed an increase in asthma-related deaths in patients receiving
salmeterol. This finding with salmeterol is considered a class effect of LABA,
including formoterol. Currently available data are inadequate to determine
whether concurrent use of inhaled corticosteroids or other long-term asthma
control drugs mitigates the increased risk of asthma-related death from LABA.
Available data from controlled clinical trials suggest that LABA increase the
risk of asthma-related hospitalization in pediatric and adolescent patients.
SYMBICORT 160/4.5 is indicated for the maintenance treatment of airflow
obstruction in patients with chronic obstructive pulmonary disease (COPD),
including chronic bronchitis and emphysema.
SYMBICORT is NOT indicated for the relief of acute bronchospasm and should not
be initiated in patients during rapidly deteriorating or potentially
life-threatening episodes of COPD.
Please see full Prescribing Information, including Boxed WARNING.
You are encouraged to report negative side effects of prescription drugs to
the FDA. Visitwww.FDA.gov/medwatchor call 1-800-FDA-1088.
AstraZeneca is a global, innovation-driven biopharmaceutical business with a
primary focus on the discovery, development and commercialization of
prescription medicines for gastrointestinal, cardiovascular, neuroscience,
respiratory and inflammation, oncology and infectious disease. AstraZeneca
operates in over 100 countries and its innovative medicines are used by
millions of patients worldwide.
For more information about AstraZeneca in the US or our AZ&Me™ Prescription
Savings programs, please visit:www.astrazeneca-us.comor call 1-800-AZandMe
SYMBICORT is a registered trademark, and AZ&Me is a trademark, of the
AstraZeneca group of companies.
©2013 AstraZeneca. All rights reserved.
2925100 Last Updated 11/13
Contact: Media Inquiries US: Elizabeth Renz, +1 (302) 885 1936,
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