Real-world study comparing commonly prescribed COPD medicines shows choice of treatment has impact on patient outcomes

Real-world study comparing commonly prescribed COPD medicines shows choice of 
treatment has impact on patient outcomes 
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(®) 
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. 
About COPD
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 )COPD( )already 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 real-world setting.(1) 
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 countries worldwide. 
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. AstraZeneca's Canadian headquarters are 
located in Mississauga, Ontario. For more information, please visit the 
company's website at 
(1.)    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: Last accessed March 19, 2013. 
(2.)    World Health Organization (WHO). COPD Fact Sheet Number 315. Available from: Last 

        accessed January 17, 2013.

(3.)    Papi A et al. Pathophysiology of Exacerbations of Chronic Obstructive Pulmonary Disease. Proc Am Thorac Soc 
2006; 3:245-251.

(4.)    The Lung Association. The Challenge of Lung Disease in Canada. Available from:
        . Last accessed February 20, 2013.

(5.)    World Health Organization (WHO). The Global Burden of Disease. 2004 Update. Available from: Last accessed January 17, 
(6.)    BC Medical Journal. A Snapshot of Chronic Obstructive Pulmonary Disease in British Columbia and Canada. 
Available from: 
    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 patients.(1) 
Vanessa Principe Edelman Tel: 416-428-8660 
Michelle Riccio AstraZeneca Canada Tel: 905-615-6828 
SOURCE: AstraZeneca Canada Inc. 
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CO: AstraZeneca Canada Inc.
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-0- Mar/22/2013 12:00 GMT
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