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Boehringer Ingelheim GmbH and Pfizer Inc

New Analysis Supports Tiotropium as Initial Maintenance Therapy for COPD

Vienna (ots/PRNewswire)

- Treatment With Tiotropium Reduced Lung Function Decline in
Younger  Patients
NOT FOR US MEDIA
A new post-hoc analysis of data from the Understanding Potential
Long-term Impacts on Function with Tiotropium (UPLIFT(R)) trial
presented today at the European Respiratory Society (ERS) Annual
Congress demonstrated that tiotropium (SPIRIVA(R)) administered to
younger patients (less than or equal to) 50 years old) with Chronic
Obstructive Pulmonary  Disease (COPD) results in statistically
significant reductions in the rate of  lung function decline [as
measured by forced expiratory volume in one second  (FEV(1))] and
improvements in health-related quality of life [as measured by  St
George's Respiratory Questionnaire (SGRQ)]. This younger patient
population showed a 34% reduction in the rate of lung function
decline over 4  years when treated with tiotropium compared to
age-matched controls (post- bronchodilator FEV(1), 38 mL/year vs. 58
mL/year; p=0.01).(*)(1)
The data, based on 356 patients (less than or equal to) 50 years
old  enrolled in the landmark UPLIFT(R) trial, also demonstrated that
younger  patients treated with tiotropium experienced a 27% decreased
risk of  exacerbations compared with patients in the control group
[HR (95%CI) = 0.73  (0.56, 0.95); p=0.02]. Exacerbations can worsen
the clinical course of the  disease, therefore a treatment such as
tiotropium that significantly reduces  the number of COPD
exacerbations may provide patients with an improved  disease
prognosis and impact the clinical course of COPD.(2)
"These new data in younger patients reinforce the imperative to
diagnose and treat COPD patients earlier, which is meaningful to both
physicians and patients. Doctors can prescribe tiotropium with
confidence in patients younger than 50, to help them experience
improved quality of life and long-term improvement. These data
illustrate tiotropium's efficacy in potentially preserving lung
function and impacting the course of the disease in younger
patients." said Professor Roland Buhl, Head of the Pulmonary
Department at the University of Mainz, Germany.
Further evidence from UPLIFT(R) highlights benefit of early
treatment
Further evidence supporting tiotropium as initial maintenance
therapy, consistent with Global Initiative for Chronic Obstructive
Lung Disease (GOLD) guidelines,(3) came from a post-hoc analysis of
maintenance-naive patients in UPLIFT(R) which was presented at the
American Thoracic Society (ATS) Annual Congress in 2009. This
analysis evaluated the effectiveness of tiotropium in COPD patients
who had not received previous maintenance therapy with inhaled
long-acting beta-2 agonists, inhaled corticosteroids, theophyllines
or anticholinergics.(4) The results in 403 patients receiving
tiotropium and 407 control patients(*) showed that tiotropium
significantly reduced the rate of lung function decline (as measured
by FEV(1)) and produced a statistically significant improvement in
health-related quality of life (as measured by SGRQ). In addition,
the risk of hospitalisations due to COPD exacerbations was also
significantly reduced in patients receiving tiotropium compared with
patients in the control group [HR (95% CI) = 0.77 (0.62, 0.94);
p=0.012].
Tiotropium may slow the progression of COPD in patients with
early stage disease (GOLD Stage II), as measured by the rate of
decline in lung function. A prespecified subgroup analysis of
UPLIFT(R) recently published in the Lancet showed that tiotropium
reduced the rate of decline in postbronchodilator FEV(1) over 4 years
compared with control (43 mL per year vs. 49 mL per year; p=0.024).
The rate of decline in prebronchodilator FEV(1) was similar between
the groups.(5) Tiotropium also resulted in an 18% lower risk for
exacerbations and 20% fewer exacerbations (p<0.0001) compared with
control. GOLD Stage II is typically when patients start to realise
their lung function is abnormal and experience breathlessness on
exertion. Patients generally first seek treatment from their primary
care physician for COPD symptoms at this stage.(3)
"Overall, the growing body of evidence around tiotropium
highlights its efficacy as a first line maintenance therapy in the
treatment of younger patients and in those in the earlier stages of
COPD. Through earlier diagnosis and treatment with tiotropium, we can
have a positive impact on patient outcomes,' said Professor Buhl.
VIENNA, September 15 /PRNewswire/ --
(*) All patients 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
    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; 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