SYMBICORT Real-World Study Results Published in the International Journal of COPD
September 30 2015 - 8:00AM
Business Wire
US Comparative Effectiveness Study of Two
Maintenance Treatment Options for Patients with COPD
Results from a US comparative effectiveness study of two
maintenance treatment options for patients with a history of
chronic obstructive pulmonary disease (COPD) were published
recently in the International Journal of COPD. This is the first US
real-world study to examine the comparative effectiveness of
SYMBICORT® 160/4.5 (budesonide/formoterol fumarate dihydrate)
Inhalation Aerosol, an inhaled corticosteroid and long-acting
beta2-agonist combination therapy, and tiotropium bromide 18 mcg, a
long-acting muscarinic antagonist, in patients with COPD.
The study was conducted using US claims data from the HealthCore
Integrated Research Environment. The analysis included patients who
were at least 40 years old and had a diagnosis code for COPD
associated with either hospitalization, treatment in an emergency
department, and/or fill of an oral corticosteroid prescription
within 10 days of an outpatient visit. Patients were followed for
12 months after an initial prescription fill for either SYMBICORT
or tiotropium bromide. Comparative effectiveness between the two
study cohorts included analysis of healthcare utilization and costs
in the year following an initial prescription claim.
The study, titled “Comparative Effectiveness of
Budesonide/Formoterol Combination and Tiotropium Bromide Among COPD
Patients New to These Controller Treatments,” was published online
in the September issue of the International Journal of COPD.
“AstraZeneca is committed to understanding the impact of its
medicines in the real-world, beyond what is seen in controlled
clinical trials,” said Frank Trudo, MD, Medical Affairs,
AstraZeneca. “Real-world studies such as this one offer healthcare
providers and payers with valuable information that can be used to
help inform their treatment decisions.”
SYMBICORT 160/4.5 is indicated for the maintenance treatment of
airflow obstruction in patients with COPD, including chronic
bronchitis and emphysema. SYMBICORT is not indicated for the relief
of acute bronchospasm.
About COPD
COPD is a serious lung disease that includes chronic bronchitis
– resulting from constantly inflamed and irritated airways in the
lungs – and/or emphysema – resulting from damage to small air sacs
and airways in the lungs. COPD develops slowly and can progress
over time – making it harder for patients to breathe and get the
oxygen they need. Approximately 12 million adult Americans
currently are diagnosed with COPD, with an additional estimated 12
million who may have the disease, yet are undiagnosed.
About AstraZeneca
AstraZeneca (NYSE:AZN) is a global, innovation-driven
biopharmaceutical business that focuses on the discovery,
development and commercialization of prescription medicines,
primarily for the treatment of cardiovascular, metabolic,
respiratory, inflammation, autoimmune, oncology, infection and
neuroscience diseases. AstraZeneca operates in over 100 countries
and its innovative medicines are used by millions of patients
worldwide. For more information please
visit www.astrazeneca-us.com.
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
• WARNING: Long-acting beta2-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
- SYMBICORT is NOT a rescue medication
and does NOT replace fast-acting inhalers to treat acute
symptoms
- SYMBICORT should not be initiated in
patients during rapidly deteriorating episodes of asthma or
COPD
- Patients who are receiving SYMBICORT
should not use additional formoterol or other LABA for any
reason
- Localized infections of the mouth and
pharynx with Candida albicans has occurred in patients treated with
SYMBICORT. Patients should rinse the mouth after inhalation of
SYMBICORT
- Lower respiratory tract infections,
including pneumonia, have been reported following the inhaled
administration of corticosteroids
- 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
- 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. Deaths due to
adrenal insufficiency have occurred in asthmatic patients during
and after transfer from systemic corticosteroids to less
systemically available inhaled corticosteroids
- Caution should be exercised when
considering administration of SYMBICORT in patients on long-term
ketoconazole and other known potent CYP3A4 inhibitors
- As with other inhaled medications,
paradoxical bronchospasm may occur with SYMBICORT
- Immediate hypersensitivity reactions
may occur as demonstrated by cases of urticaria, angioedema, rash,
and bronchospasm
- Excessive beta-adrenergic stimulation
has been associated with central nervous system and cardiovascular
effects. SYMBICORT should be used with caution in patients with
cardiovascular disorders, especially coronary insufficiency,
cardiac arrhythmias, and hypertension
- Long-term use of orally inhaled
corticosteroids may result in a decrease in bone mineral density
(BMD). Since patients with COPD often have multiple risk factors
for reduced BMD, assessment of BMD is recommended prior to
initiating SYMBICORT and periodically thereafter
- Glaucoma, increased intraocular
pressure, and cataracts have been reported following the inhaled
administration of corticosteroids, including budesonide, a
component of SYMBICORT. Close monitoring is warranted in patients
with a change in vision or history of increased intraocular
pressure, glaucoma, or cataracts
- In rare cases, patients on inhaled
corticosteroids may present with systemic eosinophilic
conditions
- SYMBICORT should be used with caution
in patients with convulsive disorders, thyrotoxicosis, diabetes
mellitus, ketoacidosis, and in patients who are unusually
responsive to sympathomimetic amines
- Beta-adrenergic agonist medications may
produce hypokalemia and hyperglycemia in some patients
- The most common adverse reactions ≥3%
reported in COPD clinical trials included nasopharyngitis, oral
candidiasis, bronchitis, sinusitis, and upper respiratory tract
infection
- 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
- Beta-blockers may not only block the
pulmonary effect of beta-agonists, such as formoterol, but may
produce severe bronchospasm in patients with asthma
- ECG changes and/or hypokalemia
associated with nonpotassium-sparing diuretics may worsen with
concomitant beta-agonists. Use caution with the coadministration of
SYMBICORT
INDICATIONS
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.
Please see full Prescribing Information, including
Boxed WARNING and Medication Guide.
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AstraZenecaUSMedia Inquiries:Michele Meixell, +1
302-885-2677
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