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

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

June 29, 2006

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

 
    BIRMINGHAM, England, June 29 /Xinhua-PRNewswire/ --
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.

    For more information, please contact:

     Anette Orheim, 
     AstraZeneca
     Tel:    [phone] 
     Mobile: [phone]

     Jim Baxter, 
     Cohn & Wolfe 
     Tel:    [phone]
     Mobile: [phone]

SOURCE  AstraZeneca Plc