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


    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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      Boehringer Ingelheim GmbH
      External Communications
      Ute E Schmidt
      Binger Strasse 173
      55216 Ingelheim am Rhein
      Tel.: +49-6132-779-7296
      Pfizer Inc.
      Associate Director, Communications UK and Europe
      Louise Clark
      Walton Oaks
      Dorking Road
      Surrey, KT20 7NS
      Tel.: +44-1737-331-192

ots Originaltext: Boehringer Ingelheim GmbH and Pfizer Inc
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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:

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