SYMBICORT® (budesonide/formoterol fumarate dihydrate) Study in African American Patients With Asthma Shows Improved Lung Function Compared to Budesonide Alone

WILMINGTON, Del., Nov. 2, 2010 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) announced today that results from TITAN, a 12-week study of SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol in African American patients with moderate to severe persistent asthma, showed significant improvement in lung function for patients taking SYMBICORT compared with those using budesonide alone.(1) Safety and efficacy results from the TITAN study(1,2) are consistent with previous studies conducted among predominantly Caucasian patients taking SYMBICORT.(3,4)  The study results were presented at CHEST 2010, the 76th annual meeting of the American College of Chest Physicians in Vancouver, British Columbia.

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SYMBICORT is a combination asthma medication that contains both an inhaled corticosteroid (ICS) (budesonide) and a long-acting beta-agonist (LABA) (formoterol), and is indicated for the treatment of asthma in patients 12 years of age and older not adequately controlled on a long-term asthma control medication, such as an ICS, or whose disease severity clearly warrants initiation of treatment with both an ICS and LABA.(5)

"African Americans are approximately 20 percent more likely to have been diagnosed with asthma in their lifetime compared to Caucasians(6), and TITAN is one of the few asthma studies to examine a product like SYMBICORT in African American patients alone," said Dr. Ubaldo Martin, Director of Clinical Research at AstraZeneca.

Results from the 12-week TITAN study showed:

• Patients experienced greater improvement in predose FEV1 from baseline to the mean during the treatment period with SYMBICORT compared to budesonide (primary variable, P<.008)(1)
• Improvements in morning and evening peak expiratory flow (PEF) were significantly greater from baseline through the end of treatment for patients using SYMBICORT compared to budesonide (P<.001)(1)
• The most common adverse events (greater than or equal to 3% total) for patients receiving SYMBICORT or budesonide were headache, nasopharyngitis, and upper respiratory tract infection; most adverse events were mild to moderate in intensity(2)  
• The incidence of treatment-related adverse events was low (SYMBICORT, 1.3%; budesonide, 0.6%).(2)  There were no deaths among patients participating in the study(2)

About TITAN

TITAN was a 12-week, randomized, double-blind, double-dummy, multicenter phase IV U.S. study. It included 311 African American (self-reported) patients 12 years of age and older with moderate to severe persistent asthma previously treated with medium- to high-dose inhaled corticosteroids (ICS). Patients who were symptomatic after two weeks of receiving two inhalations, twice daily of budesonide dry powder inhaler (DPI) 90 mcg were randomized to receive two inhalations, twice daily of SYMBICORT pMDI 160/4.5 mcg or two inhalations, twice daily of budesonide DPI 180 mcg.(1,2)

About Asthma in African Americans

Asthma disproportionately affects the African American population, as they are approximately 20 percent more likely to have been diagnosed with asthma in their lifetime compared to Caucasians.(6) The asthma-related death rate for African Americans is 200 percent higher than Caucasians, and African Americans are much more likely to receive care in emergency rooms and to be hospitalized for asthma.(6) According to the Asthma and Allergy Foundation of America (AAFA), ethnic differences in asthma prevalence, morbidity, and mortality are highly correlated with poverty, urban air quality, indoor allergens, lack of patient education, and inadequate medical care.(7)

Updated 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. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients
• When treating patients with asthma, prescribe SYMBICORT only for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (eg, discontinue SYMBICORT) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use SYMBICORT for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids

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. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available 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 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 eosinophilic conditions.

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 reactions greater than or equal to 3% reported in clinical trials included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis.

Indications

SYMBICORT is indicated for the treatment of asthma in patients 12 years and older (also see boxed WARNING).

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 asthma.

Please see full Prescribing Information, including boxed WARNING, and visit www.MySYMBICORT.com

NOTES TO EDITORS:

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines.  As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of $32.8 billion in 2009. In the United States, AstraZeneca is a $14.8 billion healthcare business. For more information about AstraZeneca in the US or our AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (1-800-292-6363).

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References:

(1) Spector, S., Martin, U., Uryniak, T., O'Brien, C.  Effect of Budesonide/Formoterol Pressurized Metered-Dose Inhaler Versus Budesonide Dry Powder Inhaler on Pulmonary Function in Black Adolescents and Adults with Moderate to Severe Persistent Asthma [oral presentation]. American College of Chest Physicians Annual Meeting, Oct. 30-Nov. 4, 2010.

(2) Spector, S., Martin, U., Uryniak, T., O'Brien, C. Safety and Tolerability of Budesonide/Formoterol (BUD/FM) Pressurized Metered-Dose Inhaler (pMDI) in Black Adolescents and Adults with Moderate to Severe Persistent Asthma. [oral presentation]. American College of Chest Physicians Annual Meeting, Oct. 30-Nov. 4, 2010.

(3) Noonan, Michael. Efficacy and Safety of Budesonide and Formoterol in One Pressurised Metered-Dose Inhaler in Adults and Adolescents with Moderate to Severe Asthma.

(4) Corren, Jonathan. Twelve-Week, Randomized, Placebo-Controlled, Multicenter Study of the Efficacy and Tolerability of Budesonide and Formoterol in One Metered-Dose Inhaler Compared with Budesonide Alone and Formoterol Alone in Adolescents and Adults with Asthma.  Clinical Therapeutics 2007; 29(5).

(5) SYMBICORT [package insert]. Wilmington, DE: AstraZeneca LP; 2010.

(6) Akinbami, Lara.  Centers for Disease Control. NCHS Health E-Stat Asthma Prevalence, Health Care Use and Mortality: United States, 2003-05. Accessed September 16, 2010: http://www.cdc.gov/nchs/data/hestat/asthma03-05/asthma03-05.htm

(7) Allergy and Asthma Foundation of America.  Asthma Facts and Figures. Accessed September 16, 2010: http://www.aafa.org/display.cfm?id=8&sub=42

SOURCE AstraZeneca

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