Real-world evidence shows importance of treatment choice in risk of COPD
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(®)
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)
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
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.
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
(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; 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 Alexandra.email@example.com
Michelle Riccio AstraZeneca Canada Tel: 905-615-6828
SOURCE: AstraZeneca Canada Inc.
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