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De: PR Newswire
Brasil
Para: THERESA CATHARINA DE GÓES CAMPOS
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
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
06/28/2006
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
BNED: NG
FONTE: PR NEWSWIRE LATIN AMERICA
CORAL GABLES - MIAMI-US
CONTATOS: USA-MARY D'LEON
BRASIL-NÉLIA GARCIA
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E-MAILS: nelia_garcia@prnewswire.com.br
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PALAVRA-CHAVE: RJ
PALAVRA-CHAVE/RAMO DE ATIVIDADE: DIVERSOS
PALAVRA-CHAVE/EMPRESA: ASTRAZENECA PLC
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