COPD Landmark UPLIFT(R) trial proves tiotropium significantly reduces risk of death, improves quality of life, sustains lung function improvements over four years



    
    Results of 5,993 patient study UPLIFT(R) (Understanding Potential Long-
    term Impacts on Function with Tiotropium) presented today at European
    Respiratory Society Annual Congress, and published online in New England
    Journal of Medicine
    

    BURLINGTON, ON, Oct. 5 /CNW/ - Results of the UPLIFT(R) trial(1),
presented today at the European Respiratory Society (ERS) Annual Congress,
demonstrated that when patients with Chronic Obstructive Pulmonary Disease
(COPD) received tiotropium (SPIRIVA(R)), there was a statistically significant
16% decrease in the risk of death (p=0.016). This is important new research
because COPD is Canada's fourth leading cause of death and up to three million
Canadians live with COPD(2).
    The study showed sustained improvements in lung function for up to four
years (p(less than)0.001) although it did not alter the rate of decline in
lung function. The landmark study also showed reduced respiratory (p(less
than)0.05) and cardiac morbidity (p(less than)0.05) therefore reaffirming the
safety profile of tiotropium. It was published simultaneously in the online
version of the New England Journal of Medicine.
    Tiotropium, a long-acting inhaled anticholinergic medication, also
provided statistically significant improvements in health-related quality of
life, as measured by the St. George's Respiratory Questionnaire (SGRQ, p(less
than)0.001).(3) Throughout the four-year trial period, patients in the
tiotropium group consistently reported a better quality of life than at study
initiation.
    Exacerbations, which can cause distressing breathlessness, can worsen the
clinical course of the disease, so a treatment that significantly reduces them
can positively impact the clinical course of COPD.(3) UPLIFT(R) also
demonstrated that tiotropium produced a significant reduction in the number of
exacerbations per patient year (14%; p(less than)0.001) and a significant
delay in time to first exacerbation by a median of 4.1 months (p(less
than)0.001). In addition, tiotropium significantly reduced the risk of
exacerbations leading to hospitalisations (Hazard Ratio 0.86; p(less
than)0.002) versus the control group.
    "UPLIFT(R) adds significantly to our understanding of the sustained,
long-term treatment benefits of tiotropium and how it can allow COPD patients
to lead better and longer lives," said Canadian Physician Dr. Denis O'Donnell
of Kingston, Ontario. "With these findings - improved survival, quality of
life, lung function combined with the impressive safety profile - we see the
benefits of treating patients earlier, when they first seek medical
attention."

    Other study findings

    Within the four year treatment period of the trial, the effect on
survival was sustained, even when deaths occurring after early discontinuation
of study medication were included in the analysis (p=0.034). Risk of mortality
was assessed for the 30 days following the conclusion of the treatment period,
and the study revealed an 11% reduced risk of death, although it did not meet
statistical significance (p=0.086).
    Professor Marc Decramer, a study author and Professor of Medicine at the
Catholic University Hospital in Leuven, Belgium said, "UPLIFT(R) faced a
considerable challenge to demonstrate treatment benefits - unlike most other
respiratory trials; it allowed all patients to be treated with all other
concomitant respiratory medications, except for inhaled anticholinergics. In
UPLIFT(R), tiotropium performed very well over the long term by improving
survival rates, lung function, exacerbation rates, and patients' quality of
life, while also confirming its favourable safety profile. The UPLIFT(R) data
adds to the growing knowledge of how treatment can impact the clinical course
of COPD. This will allow physicians to prescribe a long-term maintenance
treatment early on with confidence."
    The data also demonstrate that tiotropium provides important benefits in
moderate disease severity patients (GOLD - Global Initiative for Chronic
Obstructive Lung Disease - Stage II).(*) Forty-six per cent of the patients in
the UPLIFT(R) trial were GOLD Stage II. This is one of the largest COPD Stage
II patient populations ever studied over four years. The results obtained for
this patient group are especially relevant as this is the stage when patients
normally first seek treatment for COPD symptoms.(3)

    
    --------------------------
    (*) Health-related quality of life was evaluated using the Saint George's
        Respiratory Questionnaire (SGRQ), where a four-point decrease in SGRQ
        score is considered to be a clinically meaningful improvement in a
        patient's health-related quality of life.

    Notes to Editors

    About the study
    

    UPLIFT(R), one of the largest COPD trials ever undertaken, involved 5,993
COPD patients from 37 countries around the globe. UPLIFT(R) is a landmark COPD
trial comparing tiotropium 18 (micro)g once daily with placebo-controlled, and
allowed all patients to continue with their normally prescribed respiratory
medications, including dose adjustments throughout the trial, except inhaled
anticholinergics.

    About COPD

    COPD is a progressive yet treatable disease that restricts patients'
lives over time and is a major cause of death and disability throughout the
world. Symptoms include cough, sputum (mucus or phlegm) production, and
breathlessness on exertion. Worsening of these symptoms often occurs and can
restrict a patient's ability to perform normal daily activities.(3) According
to the Lung Association, up to three million Canadians may have COPD.(2) The
latest World Health Organization (WHO) figures estimate that 210 million
people are currently living with COPD and more than 3 million people died from
the disease in 2005(4) - more than breast cancer and diabetes combined.(5)
Dyspnoea (breathlessness), the main symptom of COPD, is characteristically
persistent and progressive and has a serious impact on patients' quality of
life.(1) At its most severe, it even limits a patient from simple tasks such
as washing and dressing.

    UPLIFT(R) Study Design

    The four-year study was a multicentre (470 sites), multinational (37
countries), randomised, double-blind, placebo-controlled, parallel-group trial
which commenced in December 2002. The study included 5993 male and female COPD
patients. Patients were randomised 1:1 to receive either 18 (micro)g
tiotropium or placebo-controlled once daily. In both arms, patients were
allowed to take all other respiratory medications usually prescribed for the
treatment of COPD, except for inhaled anticholinergics.

    About Boehringer Ingelheim

    The Boehringer Ingelheim group is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates
globally with 135 affiliates in 47 countries and 39,800 employees. Since it
was founded in 1885, the family-owned company has been committed to
researching, developing, manufacturing and marketing novel products of high
therapeutic value for human and veterinary medicine.
    In 2007, Boehringer Ingelheim posted net sales of 10.9 billion Euro while
spending one fifth of net sales in its largest business segment Prescription
Medicines on research and development.
    For more information please visit www.boehringer-ingelheim.com.

    About Pfizer Inc.

    Founded in 1849, Pfizer is the world's largest research-based
pharmaceutical company taking new approaches to better health. Pfizer
discovers, develops, manufactures and delivers quality, safe and effective
prescription medicines to treat and help prevent disease for both people and
animals. Pfizer also partners with healthcare providers, governments and local
communities around the world to expand access to our medicines and to provide
better quality health care and health system support. At Pfizer, more than
80,000 colleagues in more than 90 countries work every day to help people stay
happier and healthier longer and to reduce the human and economic burden of
disease worldwide.

    Webcast and additional media materials

    To view the UPLIFT(R) Breaking News press briefing at the European
Respiratory Society's annual congress in Berlin, Germany, please visit
http://www.livecoder.com/clients/bi/20081005_berlin/rmf_dsl_eng.html.
    The briefing will be available for live viewing on Sunday, 5 October
16:00-16:45 (CET) and available on demand from Sunday, 5 October 18:00 (CET).
    Journalists may want to download additional information here:
<a href="http://www.boehringer-ingelheim.com/corporate/news/presspack/uplift_2008/index.asp">http://www.boehringer-ingelheim.com/corporate/news/presspack/uplift_2008/index</a>
<a href="http://www.boehringer-ingelheim.com/corporate/news/presspack/uplift_2008/index.asp">.asp</a>.

    
    References
    ----------
    (1) UPLIFT(R) results are not currently in the SPIRIVA(R) product
        monograph
    (2) The Canadian Lung Association <a href="http://www.lung.ca/media-medias/news-nouvelles_e.php?id=98">http://www.lung.ca/media-medias/news-</a>
        <a href="http://www.lung.ca/media-medias/news-nouvelles_e.php?id=98">nouvelles_e.php?id=98</a> Last accessed October 3, 2008
    (3) Global Initiative for Chronic Obstructive Lung Disease. Global
        Strategy for the Diagnosis, Management and Prevention of Chronic
        Obstructive Pulmonary Disease:
        <a href="http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2=1&intId=989">http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2</a>
        <a href="http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2=1&intId=989">=1&intId=989</a> Updated: 2007
    (4) Source: World Health Report. World Health Organization. Available
        from URL: http://www.who.int/respiratory/copd/en/
    (5) World Health Organization. World Health Report 2004. Statistical
        Annex. Annex table 2 and 3: 120-131.
    




For further information:

For further information: Boehringer Ingelheim Canada Limited, Derek
O'Toole, Director, Market Access and Communications, Phone: (905) 631-4757,
derek.otoole@boehringer-ingelheim.com; Pfizer Canada Inc., Safia
Généreux-Khali, Manager, Corporate Communications, Phone: (514) 693-4657,
Safia.Genereux-Khali@pfizer.com; Fleishman-Hillard Canada Inc, Kate Morrison,
Account Director, Healthcare, Phone: (416) 645-8201, Cell: (416) 951-6061,
kate.morrison@fleishman.ca


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