MISSISSAUGA, ON, March 22, 2013 /CNW/ - PATHOS is the largest real-world study to compare the effectiveness of two
commonly prescribed inhaled corticosteroid and long-acting beta agonist
(ICS/LABA) combination treatments for chronic obstructive pulmonary
disease (COPD) with more than one year of patient follow-up.1 An analysis of PATHOS data shows that COPD patients treated with
SYMBICORT® (budesonide/formoterol)are significantly less likely to suffer from COPD-related exacerbations
- or 'flare ups' - and are significantly less likely to be hospitalized
for COPD than those treated with ADVAIR® (fluticasone/salmeterol).1
Overall, SYMBICORT® reduced the annual rate of moderate to severe exacerbations by 26 per
cent compared to ADVAIR® (0.80 vs. 1.09 /patient-year; p<0.0001).1 The significant and clinically relevant reduction in favour of
SYMBICORT® was apparent for all types of exacerbation events (e.g. antibiotic use,
oral steroid use or hospital admission).1 Indeed, use of SYMBICORT® reduced rates of COPD-related hospitalization by 29 per cent (0.15 vs.
0.21 /patient-year; p<0.0001) with hospital days due to COPD
exacerbation 34 per cent fewer (0.63 vs. 0.95/patient-year; p<0.0001)
compared with ADVAIR®.1 This analysis of the PATHOS data was recently published in the Journal of Internal Medicine.1
"COPD is rapidly becoming one of the world's most serious health issues
and is the fourth leading cause of death in Canada," said Dr. Charlie
Chan, Professor and Vice-Chair of Medicine, University of Toronto, consultant
Respirologist, University Health Network."As a real-world evidence study, PATHOS plays an important role in
helping healthcare professionals understand the impact of COPD
treatment options on patient outcomes, and coupled with rigorous
clinical trial data analysis, can provide a more fulsome picture of
disease patterns patients are experiencing."
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; comprising a total of 19,000 patient years.1 This first published analysis of the data compares the rate of COPD
exacerbations associated with two commonly prescribed combinations.1 To allow for a valid comparison, a cohort of patients treated with
SYMBICORT® were individually matched with an equal number of patients treated with
a second ICS/LABA, ADVAIR®.1 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.1 Exacerbations were defined in the study as medical interventions such
as hospitalizations, emergency room visits and prescription of oral
steroids or antibiotics due to COPD deterioration.1
The exacerbation findings published today are the first of several
analyses of the PATHOS data. As a real-world evidence study, the findings show the impact of
the two treatment combinations in clinical practice, providing
healthcare providers, patients and payers with valuable information
that can be used to inform their treatment decisions. PATHOS also
collected data regarding rates of pneumonia events as the comparative
safety measure, the evolution of COPD care during the 11-year period
and how access to an asthma or COPD nurse impacts care. Analyses of
these data are expected in subsequent publications.
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.2 Common symptoms of COPD include breathlessness, sputum and chronic
cough.2 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.3 Over 750,000 Canadians have been diagnosed with COPD and as many as 1.6
million more people may have COPD, but remain undiagnosed.4 COPDalready kills more people worldwide than cancer 5 and is the fourth leading cause of death in Canada, causing
approximately 10,000 deaths a year.6
PATHOS is a real-world, retrospective study that examined the medical
records of 21,361 COPD patients (of which 5,468 were medically matched)
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.1 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.
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.
Combination of budesonide/formoterol more effective than
fluticasone/salmeterol in preventing exacerbations in chronic
obstructive pulmonary disease. The PATHOS study. Journal of Internal
Medicine. Available from: http://onlinelibrary.wiley.com/doi/10.1111/joim.12067/abstract. Last accessed March 19, 2013.
World Health Organization (WHO). COPD Fact Sheet Number 315. Available
from: http://www.who.int/mediacentre/factsheets/fs315/en/index.html. Last accessed January 17, 2013.
Papi A et al. Pathophysiology of Exacerbations of Chronic Obstructive Pulmonary
Disease. Proc Am Thorac Soc 2006; 3:245-251.
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 accessed February 20, 2013.
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 January 17, 2013.
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 February 20, 2013.
*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
SOURCE AstraZeneca Canada Inc.