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

Tuesday, 19 March 2013

AstraZeneca today announced that an analysis of data from real world study PATHOS, published in the Journal of Internal Medicine, show that chronic obstructive pulmonary disease (COPD) patients treated with SYMBICORT® Turbuhaler® (budesonide/formoterol) are significantly less likely to suffer from COPD-related exacerbations – or ‘flare ups’ – and are significantly less likely to be hospitalised for COPD than those treated with SERETIDE™ (fluticasone/salmeterol).1 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 COPD with more than one year of patient follow up.1

Overall, budesonide/formoterol reduced the annual rate of moderate to severe exacerbations by 26% compared to fluticasone/salmeterol (0.80 vs. 1.09 /patient-year; p<0.0001).1 The significant, and clinically relevant reduction in favour of budesonide/formoterol was apparent for all types of exacerbation event (e.g. antibiotic use, oral steroid use or hospital admission).1 Indeed, use of budesonide/formoterol reduced rates of COPD-related hospitalisation 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 fluticasone/salmeterol.1

Dr. Kjell Larsson, Professor of Respiratory Medicine at the Karolinska Institute in Stockholm said: “So called ‘real world’ studies, such as PATHOS, together with randomised prospective studies, play an important role in answering questions about the value of medicines in delivering better, cost-effective healthcare to patients. These findings can help physicians and the healthcare community to understand disease patterns and create a fuller picture of treatment effects and what patients are experiencing.”

Briggs Morrison MD, AstraZeneca Executive Vice President for Global Medicines Development, said: “PATHOS is an example of how real world evidence can complement randomised clinical trials, in this case to better understand the outcomes of COPD treatment. COPD is a debilitating disease that currently affects 210 million people worldwide and will grow to become the third leading cause of death by 2020. COPD exacerbations are a major driver of the direct costs associated with the disease. With a portfolio of products and a robust development pipeline, AstraZeneca sees respiratory medicine as an area where our expertise can make a real difference for patients and thereby provide growth for our business.”

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.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 budesonide/formoterol were individually matched with an equal number of patients treated with a second ICS/LABA, fluticasone/salmeterol.1 Investigators used a statistical technique called “propensity score matching” to minimise 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 hospitalisations 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 hospitalisations, 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 COPD is rapidly becoming one of the world’s most serious health issues, with total deaths from COPD projected to increase by more than 30% in the next 10 years,2 making COPD the third leading cause of death worldwide.4 COPD already kills more people worldwide than cancer.5


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.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 analysed by Uppsala University to provide high quality evidence of outcomes in a real-world setting.1

About Real-World Evidence

Unlike randomised, 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 minimise 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 commercialisation 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. For more information please visit:


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1. Combination of budesonide/formoterol more effective than fluticasone/salmeterol in preventing exacerbations in chronic obstructive pulmonary disease. The PATHOS study. Larsson K et al. Journal of Internal Medicine, 2013; doi:10.1111/joim.12067. Available online:
2. World Health Organization (WHO). COPD Fact Sheet Number 315. Available from: Last accessed 17 January, 2013.
3. Papi A et al. Pathophysiology of Exacerbations of Chronic Obstructive Pulmonary Disease. Proc Am Thorac Soc 2006; 3:245–251.
4. European Lung Foundation. Burden in Europe. Available at: Last accessed 17 January, 2013.
5. World Health Organization (WHO). The Global Burden of Disease. 2004 Update. Available from: Last accessed 17 January, 2013.