MISSISSAUGA, ON, June 17, 2013 /CNW/ - A second analysis of data from
real-world study PATHOS, recently published in the British Medical Journal, shows that treatment of chronic obstructive pulmonary disease (COPD)
patients with SYMBICORT® (budesonide/formoterol) was associated with a lower incidence of
pneumonia and pneumonia related death, compared to treatment of COPD
patients with ADVAIR® (fluticasone/salmeterol).i PATHOS is the largest real-world study to compare the effectiveness and
safety of two commonly prescribed inhaled corticosteroid and
long-acting beta agonist (ICS/LABA) combination treatments for COPD
with more than one year of patient follow-up.i
Overall, the ADVAIR® treatment group was associated with a 73% higher pneumonia rate (rate
ratio [RR] 1.73 [95% confidence interval [CI] 1.57-1.90]; p<0.001; event-based number needed to treat [NNT]=23 [95% CI18-37]), with
event rates of 11.0 per 100 patient-years compared to 6.4 per 100
patient-years for the SYMBICORT® group.i Similarly, the ADVAIR® treatment group was associated with 74% higher pneumonia-related
hospital admissions than the SYMBICORT® treatment group (RR 1.74 [95% CI 1.56-1.94]; p<0.001; event-based number NNT=34 [95% CI 24-59]), with 7.4
hospitalizations per 100 patient-years in the ADVAIR® treatment group compared to 4.3 hospitalizations per 100 patient-years
in the SYMBICORT® treatment group.i A corresponding 82% increase in hospital days (53 versus 29 days per
100 patient-years, respectively; p<0.001) was associated with the ADVAIR® treatment group.i
The average duration of pneumonia-related hospitalizations was similar
for both groupsi but the ADVAIR® treatment group was associated with a higher risk of pneumonia-related
death (97 deaths) compared to the SYMBICORT® treatment group (52 deaths) (hazard ratio [HR] 1.76; 95% CI 1.22-2.53; p=0.0025).i
"As a frequent complication of COPD, pneumonia is associated with
considerable health cost and mortality" said Dr. Charlie Chan,
Professor and Vice-Chair of Medicine, University of Toronto, consultant
Respirologist, University Health Network. "This data is significant as
it is the first to compare pneumonia rates between two commonly
prescribed ICS/LABA combinations in the same matched COPD study
population, and can help uncover gaps in care, providing additional
information on the efficacy and safety of treatments as experienced in
the real-world setting."
A previous analysis of PATHOS data regarding the risk of COPD related
moderate and severe exacerbations and hospitalizations was published
earlier this year in the Journal of Internal Medicine.ii Together, these analyses of real-world evidence provide insight into
the impact of the two treatment combinations in clinical practice,
providing healthcare providers, patients and payers with valuable
information to further inform their treatment decisions.
The 11-year PATHOS study, led by Uppsala University, retrospectively
examined the medical records of 5,468* ICS/LABA-treated patients in
Sweden from 1999 to 2009; a total of 19,000 patient years.i This second published analysis of the data compares the rate of
pneumonia associated with two commonly prescribed combinations.i To allow for a valid comparison, a cohort of patients treated with
ADVAIR® were individually matched with an equal number of patients treated with
SYMBICORT®, a second ICS/LABA.i Investigators used a statistical technique called "propensity score
matching" to minimize bias and ensure the two ICS/LABA-treated groups
were comparable in terms of variables including age, gender, and
measures of disease severity such as medication use, COPD
co-morbidities, previous hospitalizations for any cause and
exacerbation rates for COPD, and other conditions like respiratory
infections prior to the first ICS/LABA prescription.i
COPD encompasses two serious lung diseases - emphysema and chronic
bronchitis - which result in chronic airway inflammation and
progressive loss of lung function, making it difficult to breathe
normally.iii Common symptoms of COPD include breathlessness, sputum, and chronic
cough.iv People with COPD are likely to experience COPD exacerbations, an acute
worsening of symptoms that are a key driver of increased mortality and
have been linked to a decline in lung function and worsening overall
health.iv Over 750,000 Canadians have been diagnosed with COPD and as many as 1.6
million more people may have COPD, but remain undiagnosed.v COPD already kills more people worldwide than cancervi and is the fourth leading cause of death in Canada, causing
approximately 10,000 deaths a year.vii
PATHOS was a real-world, retrospective study that examined the medical
records of 21,361 COPD patients over an 11-year period in Sweden to
better understand the evolution of COPD care and the impact of
different COPD management strategies on outcomes for patients.i,ii It is the largest and longest real-world study to compare the
effectiveness and safety of two commonly prescribed ICS/LABA
combination treatments for COPD. Medical records' data was linked to
national, mandatory Swedish healthcare registries, including hospital,
drug, and cause of death register data for 1999-2009, and analyzed by
Uppsala University to provide high quality evidence of outcomes in a
About Real-World Evidence
Unlike randomized, controlled clinical trials, real-world evidence
studies use observational data, such as electronic medical records and
healthcare registries, to create deeper insights into unmet clinical
need, the burden of illness, the cost of care or the actual, rather
than expected, impact of management strategies or treatments in a
real-world setting. AstraZeneca is committed to understanding the
impact of its medicines in the real-world, beyond what is seen in
controlled clinical trials. These insights will help AstraZeneca
develop medicines that improve the treatment of disease and help inform
healthcare decision-making to ensure effective use of medicines that
minimize the burden on patients and healthcare budgets.
* 9,893 ICS/LABA-treated patient records were analyzed and
propensity-matched, a common means of balancing study groups to
minimize bias when randomization is not possible or appropriate.
Matching of these 9,893 patients (7,155 budesonide/formoterol; 2,738
fluticasone/salmeterol) yielded two matched cohorts each of 2,734
About SYMBICORT® (budesonide/formoterol)
SYMBICORT® (budesonide/formoterol) provides both the anti-inflammatory
corticosteroid budesonide and the rapid and long-lasting bronchodilator
formoterol in the same device - the SYMBICORT® Turbuhaler®. SYMBICORT® (budesonide/formoterol) is indicated for the treatment of COPD in 88
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.
AstraZeneca's Canadian headquarters are located in Mississauga,
Ontario. For more information, please visit the company's website at www.astrazeneca.ca.
i Pneumonia and pneumonia related mortality in patients with COPD treated
with fixed combinations of inhaled corticosteroid and long acting β2
agonist: observational matched cohort study (PATHOS). British Medical
Journal. Available from: http://www.bmj.com/content/346/bmj.f3306. Last accessed June 4, 2013.
ii Larsson K, Janson C, Lisspers K, et al. Combination of
budesonide/formoterol more effective than fluticasone/salmeterol in
preventing exacerbations in chronic obstructive pulmonary disease: the
PATHOS study. J Intern Med 2013 Mar 15 [Epub ahead of print].
iii World Health Organization (WHO). COPD Fact Sheet Number 315. Available
from: http://www.who.int/mediacentre/factsheets/fs315/en/index.html. Last accessed February, 2013.
iv Papi A, Luppi F, Franco F, et al. Pathophysiology of Exacerbations of
Chronic Obstructive Pulmonary Disease. Proc Am Thorac Soc 2006;
v The Lung Association. The Challenge of Lung Disease in Canada.
Available from: http://www.lung.ca/involved-impliquez/federalelection-electionfederale/background-contexte/index_e.php#s4. Last reviewed June 4, 2013.
vi World Health Organization (WHO). The Global Burden of Disease. 2004
Update. Available from: http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf. Last accessed June 4, 2013.
vii BC Medical Journal. A Snapshot of Chronic Obstructive Pulmonary Disease
in British Columbia and Canada. Available from: http://www.bcmj.org/article/snapshot-chronic-obstructive-pulmonary-disease-british-columbia-and-canada. Last accessed June 4, 2013.
SOURCE: AstraZeneca Canada Inc.
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