Tag: safety

Long-Term Study Demonstrates Safety and Efficacy of SYMBICORT® in African American Patients with Asthma

AstraZeneca (NYSE:AZN) today announced results from a long-term study comparing SYMBICORT® (budesonide/ formoterol fumarate dihydrate) Inhalation Aerosol 160/4.5 mcg with budesonide pressurized metered-dose inhaler (pMDI) 160 mcg in self-reported African American patients with moderate to severe persistent asthma. The data demonstrated that SYMBICORT treatment resulted in significant improvement in lung function compared to treatment with budesonide alone, and safety results indicated that patients in the SYMBICORT group had fewer exacerbations over the randomized study period compared to patients treated with budesonide.1-2 The incidence of adverse events (AEs) was similar between the two groups.2 The results were presented in a poster at the 2011 American Thoracic Society (ATS) International Conference in Denver.

“Data from this year-long study of SYMBICORT supports our understanding of the product’s efficacy and safety in African American patients.”

SYMBICORT is a combination asthma medication that contains both an inhaled corticosteroid (ICS) (budesonide) and a long-acting beta-agonist (LABA) (formoterol). It 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.3

“African American patients are disproportionately affected by asthma – asthma prevalence is higher for African Americans than for Caucasians,” said Dr. Ubaldo Martin, Director of Clinical Research at AstraZeneca. “Data from this year-long study of SYMBICORT supports our understanding of the product’s efficacy and safety in African American patients.”

There have been few prior studies evaluating combination asthma treatment in specific ethnic populations at higher risk for asthma prevalence. Results from this 52-week study are consistent with safety and efficacy data from the TITAN study, a 12-week study of SYMBICORT in African American patients, and with previous SYMBICORT studies conducted among predominantly Caucasian patients.4-6

About the Study

The 52-week, randomized, double-blind Phase III study included 742 self-reported African American patients 12 years of age and older with moderate to severe persistent asthma. After two weeks of receiving two inhalations, twice daily of budesonide 160 mcg, patients were randomized to receive two inhalations, twice daily of SYMBICORT 160/4.5 mcg or two inhalations, twice daily of budesonide 160 mcg.2

Results from the study showed:

Fewer patients receiving SYMBICORT (7.7%) compared to budesonide (14.0%) had ?1 asthma exacerbation (oral/systemic corticosteroid use, an asthma-related hospitalization, or emergency room/urgent care visit) (P=.006) 2
The time to first asthma exacerbation was longer in patients treated with SYMBICORT compared to budesonide (P=.018) 2
Similar percentages of patients had ?1 AE, the most common AEs were headache, nasopharyngitis, sinusitis and viral upper respiratory tract infection2
Treatment with SYMBICORT resulted in significantly greater improvements in predose forced expiratory volume in one second (FEV1), predose forced vital capacity (FVC), and morning peak expiratory flow (AM PEF) compared to budesonide1
Improvements in predose FEV1 were observed after two weeks of randomized treatment with SYMBICORT, without diminution of effect relative to budesonide during the treatment period1

No new safety concerns were identified with SYMBICORT during the course of the study. The most common adverse events for patients receiving SYMBICORT or budesonide were headache, nasopharyngitis, sinusitis and viral upper respiratory tract infection.2

About Asthma in African Americans

African Americans are more likely to be diagnosed with asthma in their lifetime, and asthma prevalence is higher in African American patients compared to Caucasians.7

Important Safety Information, including boxed WARNING3

WARNING: ASTHMA RELATED DEATH

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 ?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

About AstraZeneca

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.com or call 1-800-AZandMe (292-6363).

References:
1. Brown, R.W. Differential Long-term Pulmonary Function Outcomes of Budesonide/Formoterol Pressurized Metered-Dose Inhaler pMDI and Budesonide pMDI in African-American Patients with Asthma. [poster]. American Thoracic Society, May 13-18, 2011, Denver, CO. Abstract #17354.
2. Brown, R.W. Long-term Safety of Budesonide/Formoterol Pressurized Metered-Dose Inhaler Budesonide pMDI in African-American Patients with Asthma: Asthma Exacerbation Adverse Events. American Thoracic Society, May 13-18, 2011, Denver, CO. Abstract #17354.
3. Symbicort Prescribing Information. AstraZeneca.
4. 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, October 30-November 4, 2010. Vancouver, BC, Canada.
5. 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, October 30-November 4, 2010. Vancouver, BC, Canada.
6. Noonan, Michael. Efficacy and Safety of Budesonide and Formoterol in One Pressurised Metered-Dose Inhaler in Adults and Adolescents with Moderate to Severe Asthma.
7. American Lung Association. Epidemiology & Statistics Unit, Research and Program Services. Trends in Asthma Morbidity and Mortality, February 2010. Accessed April 27, 2011: http://www.lungusa.org/finding-cures/our-research/trend-reports/asthma-trend-report.pdf