Theresa Catharina de Góes Campos

  De: PR Newswire Brasil
Assunto: 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
28 de junho de 2006 10:51 HORALOCAL

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

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 28 /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
"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.

(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, +46-46-33-80-87, or Mobile,
+46-709-13-19-52; Jim Baxter, Cohn & Wolfe, +44-207-331-5371, or
Mobile, +44-790-060-5652


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