�A 52-week study examined the long-term safety of the upkeep combination asthma therapy, SYMBICORT� (budesonide/formoterol fumarate dehydrate) Inhalation Aerosol, at up to double the approved dose.1 More than 700 patients ages 12 years and elderly with tone down to grievous persistent asthma, and wHO had been previously toughened with inhaled corticosteroids, participated in the study.1 Safety was evaluated through several assessments, including the incidence of asthma exacerbations and inauspicious events.1 The study showed that SYMBICORT, a combination of budesonide, an inhaled corticoid (ICS), and formoterol, a rapid and long-acting beta2-agonist (LABA), had a safety profile like to 1 of its mono-components, budesonide.1,2 Results were published online and will be a part of the September-October issue of Allergy and Asthma Proceedings.
"In this survey, no significant or unexpected adverse events were ascertained when combination formoterol, a long-acting beta2-agonist, with budesonide for up to one year,"1 said written report investigator, Bruce Prenner, MD, University of California, San Diego in La Jolla, California. "The safety information obtained during this cogitation are reassuring and in line with NIH guidelines recommending combination therapy, such as SYMBICORT, for patients whose consideration requires more than than inhaled corticosteroids alone."1,3
About the Study Results
The study demonstrated that the percentage of patients with at least one asthma exacerbation was significantly lower (p=0.006) with four-spot inhalations twice-daily of SYMBICORT 160/4.5 mcg (12.2%) and numerically lour (p=0.117) with two inhalations twice-daily of SYMBICORT 160/4.5 mcg (14.4%) versus four inhalations twice day-by-day of budesonide 160 microgram (21.8%).1 In the U.S., SYMBICORT is not approved for manipulation as quatern inhalations twice-daily and is only sanctioned for habit as two inhalations twice-daily. 2 The proportion of asthma exacerbations per patient-treatment year was significantly glower with both doses of SYMBICORT (0.174, p=0.004, quadruplet inhalations; 0.185, p=0.049, two inhalations) compared to budesonide (0.315).1 The number of patients with at least one hospitalization, emergency department or pressing care call in due to an bronchial asthma exacerbation was not statistically significantly different between the treatment groups.1 In addition, no clinically meaningful differences in laboratory, eCG, or Holter monitor (records heart's electrical activity4) variables were ascertained between groups.1
Results also demonstrated that SYMBICORT was well tolerated for up to 52 weeks.1 The percentages of patients wHO experienced whatever adverse events were similar for both dosing blazon of SYMBICORT (88.9%, four inhalations; 84.1%, two inhalations) and budesonide (88.7%).1 Adverse events were mainly mild or moderate in vividness.1 The most coarse drug-related adverse events, as judged by the investigators, (>2% overall) included oral candidiasis (9.7%), tremor (3.2%) and pharyngolaryngeal pain (2.0%).1 Patient discontinuance rates due to drug-related adverse events were scummy and like across all treatment groups.1
"The safety profile of SYMBICORT is based on a robust U.S. development political platform, which evaluated safety in over 6,000 patients treated with SYMBICORT in Phase I, II and III studies,"5 aforesaid Christopher O'Brien, MD, PhD, Senior Director, Medical Science, AstraZeneca. "AstraZeneca is committed to the safety of patients, and we continuously monitor the safety profiles of all our medications."
About the Study Design
The safety profile of SYMBICORT was assessed during a 52-week randomized, double-blind, parallel-group, single-dummy, multicenter Phase III study1 involving 708 patients ages 12 years and older with moderate to severe lasting asthma previously treated with ICS therapy,1 either alone or in combination.1 After a two-week run-in period when all patients were placed on two inhalations twice-daily budesonide pressurized metered-dose inhaler (pMDI) 160 micrograms (mcg) and, as needful, albuterol 90 mcg,1 patients were randomized 3:1:1 to receive either four inhalations twice-daily of SYMBICORT pMDI 160/4.5 mcg (N=443), which is twice its highest recommended dose, 2 2 inhalations twice-daily of SYMBICORT pMDI 160/4.5 microgram (N=132), or four inhalations twice-daily of budesonide pMDI 160 microgram (N=133).1
The study assessed patients at 8 visits over the 52-week period.1 Safety was evaluated based on the incidence of asthma exacerbations, defined as the use of oral or systemic corticosteroids, hospitalization, or an emergency section or pressing care visit due to asthma exacerbations, adverse events, serious inauspicious events and discontinuations ascribable to inauspicious events.1 Additional base hit assessments included laboratory evaluations, 24-hour urinary cortisol levels, vital signs, physical examinations, 12-lead electrocardiograms (ECGs), and 24-hour Holter monitoring.1 Adverse events were recorded in day-to-day logs reviewed at each study visit.1
About SYMBICORT
SYMBICORT is a combination therapy indicated for the long-term maintenance discussion of bronchial asthma in patients 12 age of historic period and sr..2 Administered twice everyday,2 SYMBICORT is a combination of two proved asthma medications budesonide, an inhaled corticoid (ICS), and formoterol, a rapid and long-acting beta2-agonist (LABA).2 SYMBICORT does not replace fast-acting inhalers and should not be used to do by acute symptoms of asthma.2
Important Safety Information
Long acting beta2-adrenergic agonists may increase the risk of infection of asthma-related death. Therefore, when treating patients with asthma, SYMBICORT should exclusively 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 knowledgeability of handling with two maintenance therapies. Data from a turgid 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 increment 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 succor 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 world Health Organization are transferred from systemically active corticosteroids. Deaths due to adrenal insufficiency take occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.
Patients world Health Organization are receiving SYMBICORT twice daily should not consumption 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, worry, 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 external healthcare business enterprise engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is ane 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.
References
1. Peters, S.P., Prenner, B.M., Mezzanotte, W.S., Martin, P., O'Brien, C.D. Long-term ety and asthma control with budesonide/formoterol versus budesonide pressurized metered-dose inhaler in asthma patients.
2. Symbicort Prescribing Information.
3. National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma.
4. National Heart, Lung, and Blood Institute. What Are Holter and Event Monitors? Retrieved on 28 July 2008. http://www.nhlbi.nih.gov/health/dci/Diseases/holt/holt_what.html.
5. Data on File, DA-SYM-01.
Edelman PR, NYC
New York, NY
United States
http://www.edelman.com
More info
