MISSISSAUGA, ON (Tuesday, March 19 ) - 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% 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 event (e.g. antibiotic use, oral steroid use or hospital admission).1 Indeed, use of SYMBICORT® reduced rates of COPD-related hospitalization by 29% (0.15 vs. 0.21 /patient-year; p<0.0001) with hospital days due to COPD exacerbation 34% 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 COPD already kills more people worldwide than cancer5 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.
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.
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:http://onlinelibrary.wiley.com/doi/10.1111/joim.12067/abstract. Last accessed March 19, 2013.
2. 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.
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:http://www.lung.ca/involved-impliquez/federalelection-electionfederale/background-contexte/index_e.php#s4. Last reviewed February 20, 2013.
5. 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.
6. 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 patients.1