Real-world evidence shows importance of treatment choice in risk of COPD related pneumonia

Real-world evidence shows importance of treatment choice in risk of COPD 
related pneumonia 
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 
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 groups(i) 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; 
"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 
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) 
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.(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 
cancer(vi )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 
real-world setting.(i) 
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 patients.(i) 
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 
(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: 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: 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; 3:245-251.
(v) The Lung Association. The Challenge of Lung Disease in Canada. Available 
nd-contexte/index_e.php#s4. Last reviewed June 4, 2013.
(vi) World Health Organization (WHO). The Global Burden of Disease. 2004 
Update. Available from:
pdf. Last accessed June 4, 2013.
(vii) BC Medical Journal. A Snapshot of Chronic Obstructive Pulmonary Disease 
in British Columbia and Canada. Available from:
ish-columbia-and-canada. Last accessed June 4, 2013. 
Alexandra Fahmey Edelman Tel: 416-849-1516 
Michelle Riccio AstraZeneca Canada Tel: 905-615-6828   
SOURCE: AstraZeneca Canada Inc. 
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CO: AstraZeneca Canada Inc.
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