Wilmington, DE - May 22, 2007 - New data demonstrated that the combination asthma therapy, SYMBICORT® (budesonide/formoterol fumarate dihydrate), led to significant improvements in health-related quality of life (HRQL) and greater patient-reported satisfaction with asthma treatment, versus its monocomponents (budesonide or formoterol) or placebo. The results from these two 12-week randomized, double-blind trials were presented at the American Thoracic Society (ATS) 2007 International Conference held in San Francisco, May 18-23.
"Asthma is a chronic disease that can have a significant effect on patients' day-to-day routine, including participating in activities, such as walking to the store or even playing with their children," said Dr. Kevin R. Murphy, Clinical Professor, University of Nebraska Medical Center. "For the millions of asthma sufferers in the U.S., and especially for those whose condition is not adequately controlled with their current medication, SYMBICORT will provide a new option for patients to help manage and control their asthma, allowing them to get back to their daily activities."
SYMBICORT is a recently approved, combination therapy indicated for the long-term maintenance treatment of asthma in patients 12 years of age and older. SYMBICORT does not replace fast-acting inhalers and should not be used to treat acute symptoms of asthma. Studies of patients treated with SYMBICORT demonstrated clinically significant improvement in lung function occurring within 15 minutes of beginning treatment. SYMBICORT has safety data in long-term studies of up to one year, and has a robust cardiac safety profile.
"The studies presented at this year's ATS conference provided valuable data on asthma control and asthma-related quality of life with SYMBICORT," said Chris O'Brien, Senior Director, Medical Science, AstraZeneca. "Asthma sufferers will have a new, rapid-acting combination treatment to help them achieve asthma control."
Administered twice daily, SYMBICORT is a combination of two proven asthma medications - budesonide, an inhaled corticosteroid (ICS), and formoterol, a rapid and long-acting beta agonist (LABA). SYMBICORT is approved in the U.S. in two dose strengths, 80/4.5 and 160/4.5 μg of budesonide and formoterol, respectively, for patients whose disease is not adequately controlled on other asthma-controller medications or whose disease severity clearly warrants initiation of treatment with two maintenance therapies.
HRQL and Patient Satisfaction Study Results
Abstract #954448: This 12-week, randomized, double-blind, placebo-controlled, multicenter study measured HRQL in 553 patients with moderate-to-severe persistent asthma treated with one of five therapies: Two inhalations with SYMBICORT in one pressurized meter-dose inhaler (pMDI) 160/4.5 micrograms (mcg); budesonide pMDI 160 mcg; formoterol via dry-powder inhaler (DPI) 4.5 mcg; budesonide pMDI 160 mcg + formoterol DPI 4.5 mcg in separate inhalers; or placebo, each bid. HRQL was assessed using the standardized Asthma Quality of Life Questionnaire [AQLQ(S)] - a validated survey that measures how asthma affects a person's daily activities, emotional functioning, and symptoms - and using patient and physician global assessments.
Results showed that SYMBICORT led to statistically significant and clinically meaningful improvements in AQLQ(S) scores versus formoterol DPI or placebo. SYMBICORT also significantly improved AQLQ(S) scores, compared with budesonide pMDI on all measures except for emotional function. Patient- and physician-reported global assessments showed that a significantly higher percentage of SYMBICORT patients experienced health improvements and managed asthma symptoms better than placebo and budesonide alone, but not formoterol alone.
Abstract #954575: This 12-week, randomized, double-blind, placebo-controlled, multicenter study measured satisfaction to treatment in 390 patients with mild-to-moderate asthma previously treated with inhaled corticosteroids. Patients were randomized to receive treatment with two inhalations with SYMBICORT 80/4.5 mcg, budesonide pMDI 80 mcg, formoterol DPI 4.5 mcg, or placebo, each bid. Patient satisfaction was assessed using three indices of the Patient Satisfaction with Asthma Medication (PSAM) questionnaire, which measures relief of symptoms, perception of medication, and comparison with other medications based on a score of 1 (lowest) to 100 (highest).
Overall, SYMBICORT resulted in significantly higher satisfaction scores on all domains compared with the other treatment groups, including:
- Control relief index: SYMBICORT, 74.3 vs. budesonide pMDI, 59.2; formoterol DPI, 62.2; or placebo, 38.3
- Perception of medication index: SYMBICORT, 74.9 vs. budesonide pMDI, 60.7; formoterol DPI, 64.9; or placebo, 40.5
- Comparison with other medications index: SYMBICORT, 66.5 vs. budesonide pMDI, 47.0; formoterol DPI, 55.4; or placebo, 25.3
Asthma is a chronic inflammatory disease of the airways characterized by excessive sensitivity of the lungs, or increased reactivity of the airways, to various environmental stimuli or triggers. The inflammation results in narrowed, swollen airways, and increased mucus production. Exposure to a trigger causes tightening of muscles in the airways, or bronchoconstriction, resulting in difficulty breathing and the familiar wheeze often associated with the disease. If not properly managed, asthma can be life-threatening.
An estimated 20 million Americans have asthma, and despite the availability of many treatments for adults with asthma and guidelines on the effective treatment of asthma, the disease is still poorly controlled. The annual direct healthcare cost of the disease in the U.S. is approximately $11.5 billion. Indirect costs (e.g., lost productivity due to missed days at school or work) add another $4.6 billion, for a total cost of $16.1 billion.
Important Safety Information
Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death. Therefore, when treating patients with asthma, SYMBICORT should only be used for patients not adequately controlled on other asthma-controller medications (e.g., low-to-medium dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a long-acting beta2-adrenergic agonist), one of the active ingredients in SYMBICORT.
SYMBICORT is not indicated for the relief of acute bronchospasm.
SYMBICORT should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma.
Particular care is needed for patients who are transferred from systemically active 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 twice daily should not use additional formoterol or other long-acting inhaled beta2-agonists for any reason.
SYMBICORT should be used with caution in patients with cardiovascular disorders. Some patients may experience an increase in blood pressure or heart rate.
Common adverse events reported in clinical trials, occurring at an incidence of ≥5% of patients, regardless of relationship to treatment, included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, and stomach discomfort.
Please see full Prescribing Information and visit www.SYMBICORT-US.com.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
In the United States, AstraZeneca is a $12.44 billion healthcare business with more than 12,000 employees. For nearly three decades, AstraZeneca has offered drug assistance programs side by side with its medicines, and over the past five years, has provided over $3 billion in savings to more than 1 million patients throughout the US and Puerto Rico. AstraZeneca has been named one of the "100 Best Companies for Working Mothers" by Working Mother magazine and is the only large pharmaceutical company named to FORTUNE magazine's 2007 list of "100 Best Companies to Work For." In 2006, for the fifth consecutive year, Science magazine named AstraZeneca a "Top Employer" on its ranking of the world's most respected biopharmaceutical employers.
AstraZeneca Respiratory is dedicated to the development of new, effective treatments that help improve lung health and enhance the lives of adults and children living with asthma. Through innovative respiratory products, including SYMBICORT®, AstraZeneca is providing patients with effective treatment options to help manage their condition.
For more information about AstraZeneca, please visit: www.astrazeneca-us.com.