SYMBICORT Was Well Tolerated in 26-Week Study
WILMINGTON, Del., March 17 /PRNewswire-FirstCall/ -- A new study
analyzed long-term use of the maintenance combination asthma therapy,
SYMBICORT(R) (budesonide/formoterol fumarate dihydrate), in treating
persistent asthma in children 6 to 11 years old. The study examined the
safety of SYMBICORT in children for 26 weeks and also included efficacy
measures. For children previously treated with inhaled corticosteroid,
either alone or in combination, the study showed that long-term treatment
with SYMBICORT resulted in significantly greater improvements in lung
function and reduced healthcare resource utilization, compared with
budesonide dry powder inhaler (DPI) alone. In the study, SYMBICORT also had
a safety profile similar to its monocomponent, budesonide, which is an
approved asthma medication for children. Results were presented today at
the American Academy of Allergy, Asthma & Immunology Annual Meeting held in
Philadelphia, March 14-18, 2008.
"According to the NIH Guidelines, combination therapy is recommended
for children whose asthma is not adequately controlled with inhaled
corticosteroids alone," said lead investigator Jeffrey Leflein, MD, Allergy
& Immunology Associates of Ann Arbor, Michigan.
The study defined resource utilization directly and indirectly. Direct
utilization was defined as urgent care center visits due to asthma,
unscheduled healthcare provider visits, unscheduled phones calls to
physicians and hospitalizations due to serious adverse events. Indirect
utilization was defined as days children were unable to participate in
activities, days caregivers missed work due to their child's asthma and
caregivers' days interrupted.
AstraZeneca (NYSE: AZN) anticipates filing a supplemental new drug
application with the Food and Drug Administration for the pediatric
indication of SYMBICORT in the first half of 2008.
About the Studies (Abstracts #28 and #597)
Long-term safety was assessed during a 26-week multicenter, randomized,
open-label study that evaluated 186 children ages 6 to 11 years old with
persistent asthma that were previously treated with inhaled corticosteroid,
either alone or in combination. After one week on their usual ICS therapy,
123 patients were randomized to receive treatment with two inhalations
twice-daily SYMBICORT (budesonide/formoterol pressurized metered-dose
inhaler (pMDI)) 160/4.5 micrograms, and 63 were randomized to receive two
inhalations twice- daily budesonide dry powder inhaler (DPI) 160
micrograms.
Predose forced expiratory volume in one second (FEV1) -- how much air a
person can exhale during a forced breath in the first second of exhalation,
which is a measure of airflow and is reduced with airflow obstruction --
was measured at randomization (baseline) and weeks 2, 12 and 26. Caregivers
reported resource utilization weekly. Safety assessments included adverse
events, 24-hour urinary cortisol (nmol/24 h) and physical examination,
including change from baseline to the end of treatment in height (cm).
Results showed that mean changes in predose FEV1 were significantly
greater for SYMBICORT versus budesonide. In addition, the percentage of
patients receiving SYMBICORT (3.3%) who had at least one urgent care visit
was significantly lower compared with patients using budesonide (11.1%)
(p<0.05), and the percentage of patients using SYMBICORT (29.3%) who
experienced fewer days unable to participate in daily activities was
significantly lower compared with patients using budesonide (44.4%). In
both groups, unscheduled visits and phone calls to healthcare providers,
use of concomitant asthma medications and interrupted caregiver days were
similar. Hospitalizations were low in both groups.
Results also found that SYMBICORT was well tolerated over 26 weeks with
a similar safety profile to budesonide. The percentage of patients
reporting any adverse events was similar for SYMBICORT (84.6%) and
budesonide (85.7%). Most adverse events reported were mild or moderate in
intensity and did not lead to discontinuation. The incidence of
drug-related adverse events was low and similar with both SYMBICORT (4.9%)
and budesonide (6.3%). The most common adverse events reported were
headache, upper respiratory tract infection and nasopharyngitis, also known
as the common cold.
About SYMBICORT
SYMBICORT is a combination therapy indicated for the long-term
maintenance treatment of asthma in patients 12 years of age and older.
Administered twice daily, SYMBICORT is a combination of two proven asthma
medications -- budesonide, an inhaled corticosteroid (ICS), and formoterol,
a rapid and long- acting beta2-agonist (LABA). SYMBICORT does not replace
fast-acting inhalers and should not be used to treat acute symptoms of
asthma.
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 U.S. study 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.
Common adverse events reported in clinical trials, occurring in > 5
percent of patients, regardless of relationship to treatment, including
nasopharyngitis, headache, upper respiratory tract infection,
pharyngolaryngeal pain, sinusitis, and stomach discomfort.
For full Prescribing Information, please visit
http://www.MySYMBICORT.com
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacturing and marketing of meaningful
prescription medicines and supplier for healthcare services. AstraZeneca is
one of the world's leading pharmaceutical companies with healthcare sales
of $29.55 billion and is a leader in gastrointestinal, cardiovascular,
neuroscience, respiratory, oncology and infectious disease medicines. In
the United States, AstraZeneca is a $13.35 billion dollar healthcare
business with 12,200 employees committed to improving people's lives.
AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as
well as the FTSE4Good Index.
For more information visit http://www.astrazeneca-us.com.
SOURCE AstraZeneca
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Related links:
http://www.astrazeneca-us.com
http://www.mysymbicort.com
http://www.prnewswire.com/comp/985887.html/
CONTACT:
Michele Meeker, +1-302-885-6351,
michele.meeker@astrazeneca.com, or Katie Neff, +1-302-885-9960,
katie.neff@astrazeneca.com, both of AstraZeneca
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