Addition of Budesonide to Formoterol (Symbicort(R)) and/or a Short-Acting Beta 2 Agonist Reduces the Risk of Mortality in Patients With Severe COPD Compared to Bronchodilators Alone

Birmingham, England (ots/PRNewswire) -

For Non-US Journalists Only

- For Severe COPD Patients Treated With Budesonide Added to Either
Formoterol (Symbicort, AstraZeneca) and/or a Short Acting
Bronchodilator, There is a Reduced Risk of Mortality Compared to
Patients Treated With Only Formoterol and/or Terbutaline

Important new data from the analysis of combined data from the two
pivotal Symbicort(R) studies, announced today at the 5th
International Multidisciplinary Conference on Chronic Obstructive
Pulmonary Disease (COPD5), reveals that budesonide added to
formoterol (Symbicort(R)) and/or terbutaline significantly reduces
mortality in severe COPD over one year, compared to the
bronchodilators formoterol and/or terbutaline alone.

Today's results show fewer deaths in the Symbicort / budesonide
group compared with the bronchodilator group (p=0.036), with an
associated hazard ratio of 0.564 (p=0.039). This represents a 44%
reduction in all-cause mortality over one year for patients treated
with Symbicort / budesonide[1].

"Previous findings have shown the beneficial effects of
combination budesonide and formoterol, i.e. Symbicort, therapy in
significantly reducing COPD exacerbations", explained Professor Peter
Calverley, Aintree Chest Centre, University of Liverpool. "Today's
presentation further demonstrates the link between COPD exacerbations
and an increased risk of mortality, reinforcing the importance of
reducing these events, as indicated by COPD guidelines".

The re-analysis comprised data from 1834 patients with severe COPD
evenly distributed between the two treatment groups, i.e. budesonide
added to bronchodilators compared to bronchodilators alone.

The survival benefits in this analysis also appear to corroborate
the findings in the three year prospective TORCH (TOwards a
Revolution in COPD health) study[2], presented at the American
Thoracic Society Congress in 2006, which has reported a 17%
reduction in mortality for fluticasone/salmeterol compared with
placebo.

The retrospective pooled analysis also showed that health-related
quality of life (HRQL) - as measured by the St. Georges Respiratory
Questionnaire (SGRQ), an independently validated tool for measuring
quality of life in COPD - was the strongest predictor of mortality in
COPD, over and above any other reported predictor (e.g. lung
function, breathlessness, Body Mass Index and age), equating to
better quality of life leading to lower risk of premature death[3].
Using the SGRQ, a change of four points is defined as clinically
meaningful, equating to a patient being able to walk up a flight of
stairs without stopping or to being able to sleep without disruption
from coughing. The data presented today suggests that SGRQ scores may
have a role in identifying patients at increased risk of mortality
over 1 year.

"Previous studies have demonstrated that budesonide/ formoterol is
a very effective treatment in preventing COPD exacerbations, leading
to clinically important improvements in health-related quality of
life", explained Professor Paul Jones, St George's Hospital Medical
School, London "Today's data are important, suggesting as it does
that a combination of budesonide and formoterol may provide a
tangible survival benefit as well as improving the patients quality
of life".

The pooled-analysis, presented today at COPD5, is based upon the
data from two 1-year prospective Symbicort studies in COPD (Calverley
et al. [4] and Szafranski et al[5]), both published in the European
Respiratory Journal in 2003.

"Randomised, controlled trials are the best way of determining
whether therapy is effective in COPD. However, re-analysis of pooled
data from comparable clinical trials, as we did in this case, can
provide new and potentially important clinical insights", Professor
Calverley concluded.

References:

1) Peter Calverley, Paul Jones, Thomas Larsson, Stefan Peterson.
Preventing mortality in COPD: The value of inhaled budesonide added
to bronchodilators. Abstract scheduled for presentation at COPD5,
Birmingham, UK, 28 June 2006

2) TORCH Study Group. The TORCH (TOwards a Revolution in COPD
health) survival study protocol Eur Respir J 2004;24:206-210

3) Paul Jones, Peter Calverley, Thomas Larsson, Stefan Peterson.
SGRQ scores may help identify COPD patients at increased risk of
death in 1 year. Abstract scheduled for presentation at COPD5,
Birmingham, UK, 28 June 2006

4) Calverley PM, Boonsawat Z, Zhong N, Peterson S and Olsson H.
Maintenance therapy with budesonide and formoterol in chronic
obstructive pulmonary disease. Eur Resp J 2003; 22; 912-919.

5) Szafranski W, Cukier A, Ramirez A, Menga G, Sansores R,
Nahabedian S, Peterson S, Olsson H. Efficacy and safety of
budesonide/formoterol in the management of chronic obstructive
pulmonary disease. Eur Resp J 2003; 21: 74-81.

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