Tuesday, March 19, 2013

AstraZeneca's Symbicort better than GSK's Seretide (Advair) in reducing Exacerbations in COPD patients

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).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.

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). 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). Indeed, use of budesonide/formoterol reduced rates of COPD-related hospitalisation by 29% (0.15 vs. 0.21 /patient-year) with hospital days due to COPD exacerbation 34% fewer (0.63 vs. 0.95/patient-year) compared with fluticasone/salmeterol.

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. 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.  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. 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.

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 

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