Asia PR News

BIRMINGHAM, June 28 /PRNewswire-AsiaNet/ –

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.

SOURCE: AstraZeneca Plc

CONTACT: Anette Orheim,
AstraZeneca,
Office: +46-46-33-80-87,
Mobile: +46-709-13-19-52;

Jim Baxter,
Cohn & Wolfe,
Office: +44-207-331-5371,
Mobile: +44-790-060-5652

BIRMINGHAM, 28 June /PRNewswire-AsiaNet/ –

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 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[2]. 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 survival benefits in this analysis also
corroborates the findings in the three year prospective TORCH study, which has
reported a 17% reduction in mortality for fluticasone / salmeterol compared
with placebo."

The pooled-analysis, presented today at COPD5, is based upon the data from
two 1-year prospective Symbicort studies in COPD (Calverley et al. [3] and
Szafranski et al[4]), 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) 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

3) 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.

4) 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.

SOURCE: AstraZeneca Plc

CONTACT: AstraZeneca Office,
Anette Orheim,
+46-46-33-80-87,
Mobile - +46-709-13-19-52, or

Cohn & Wolfe Office,
Jim Baxter,
+44-207-331-5371,
Mobile - +44-790-060-5652