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28.08.2009 – 01:06

Joint source of Boehringer Ingelheim GmbH and Pfizer Inc

Data From Largest GOLD Stage II Patient Population Treated With Tiotropium Highlight the Benefits of Earlier Treatment of COPD

Ingelheim, Germany (ots/PRNewswire)

  • New UPLIFT(R) Analysis Shows Tiotropium Significantly Improves Lung Function and Quality of Life in COPD Patients With Early Stage Disease
  • Not for US Media
A new analysis of the landmark UPLIFT(R) trial, published today
in the Lancet, shows that tiotropium (SPIRIVA(R) Handihaler(R) 18
micro g) administered to Chronic Obstructive Pulmonary Disease (COPD)
patients with moderate disease severity (GOLD - Global Initiative for
Chronic Obstructive Lung Disease - Stage II) produced significant and
sustained improvements in lung function for up to 4 years.[1] This
pre-specified subgroup analysis involved 2,739 patients - the largest
group of early stage COPD patients treated with a long-acting
anticholinergic in a randomised, placebo-controlled study.
The new UPLIFT(R) analysis shows that in patients with GOLD Stage
II COPD, tiotropium may slow the progression of COPD as measured by
the rate of decline in lung function. Tiotropium reduced the rate of
decline in postbronchodilator FEV1* over 4 years compared with
control** (43 mL per year vs. 49 mL per year; p=0.024). The rate of
decline in prebronchodilator FEV1* was similar between the groups.
Improvements in pre- and postbronchodilator FEV1* were maintained
vs. control throughout the trial (101-119 mL and 52-82 mL
respectively; p<0.0001). GOLD Stage II patients taking tiotropium had
an 18% lower risk for exacerbations and 20% fewer exacerbations
(p<0.0001) compared with control. Health-related quality of life, as
measured by the St. George's Respiratory Questionnaire (SGRQ), was
better in patients treated with tiotropium than in control patients
throughout the study (p less than or equal to 0.006). There was also
a trend for reduced mortality with tiotropium compared with
control.[1]
"These results are very important for clinical practice because
this is the first large, long-term study to show that treatment with
a long-acting anticholinergic has substantial benefits in patients in
the early stages of COPD. UPLIFT(R)has shown that a significant
decline in lung function occurs early in the disease, and it is known
that exacerbations accelerate disease progression. Therefore this new
analysis confirms that we should treat COPD in the early stages with
a medication such as tiotropium that can improve lung function and
quality of life, and reduce exacerbations," said Professor Marc
Decramer, UPLIFT(R)lead investigator, Professor of Medicine and Chief
of  the Respiratory Division at the Katholieke Universiteit Leuven,
Belgium.
The social and economic burden of COPD increases steadily, with
patients becoming less independent as the disease gets worse.[2] GOLD
Stage II is typically when patients may start to realise their lung
function is abnormal and experience breathlessness on exertion. As
COPD progresses, lung function continues to decline and physical
activity becomes severely limited, disrupting the patients' and their
caregivers' ability to lead a full life, interfering with everyday
tasks and participation in family routines.[2] This can lead to
people feeling afraid, anxious, frustrated, isolated and
depressed.[2],[3] It is therefore important to ensure that patients
are diagnosed and treated as early as possible, including smoking
cessation.
"The results from the UPLIFT(R)analysis in GOLD Stage II patients
are extremely heartening. They clearly demonstrate that if patients
seek treatment from their primary care physicians earlier they may be
able to impact the clinical course of their disease and improve their
quality of life," said Dr. Anders 0strem, Specialist in Family
Medicine, Norway and Director, International Primary Care Respiratory
Group.
[*] FEV1 = Forced expiratory volume in one second.
Postbronchodilator FEV1 was measured after giving the study drugs -
tiotropium or placebo - and additional administration of short acting
bronchodilators. Prebronchodilator FEV1 was measured before
administration of study drugs.
[**] All patients from both the tiotropium group and the control
group were allowed to continue with their normally prescribed
respiratory medication, including dose adjustment throughout the
trial, except inhaled anticholinergics.
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Contact:
    Boehringer Ingelheim GmbH
    External Communications
    Ute E Schmidt
    Binger Strasse 173
    55216 Ingelheim am Rhein
    Germany
    Tel.: +49-6132-779-7296
    E: ute.schmidt@boehringer-ingelheim.com
    Pfizer Inc
    Associate Director,
    Communications UK and Europe
    Louise Clark
    Walton Oaks
    Dorking Road
    Tadworth
    Surrey, KT20 7NS
    Tel.: +44-1737-331-192
    E: Louise.clark@pfizer.com

Contact:

Contact: Boehringer Ingelheim GmbH, External Communications, Ute E
Schmidt, Binger Strasse 173, 55216 Ingelheim am Rhein, Germany, Tel.:
+49-6132-779-7296, E: ute.schmidt@boehringer-ingelheim.com; Pfizer
Inc, Associate Director, Communications UK and Europe, Louise Clark,
Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, Tel.:
+44-1737-331-192, E: Louise.clark@pfizer.com