SYMBICORT Real-World Study Results Published in the International Journal of 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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