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COPD Landmark Trial UPLIFT Proves Tiotropium Sustains Lung Function Improvements Over Four Years and Improves Survival Rate

Berlin (ots/PRNewswire)

  • Results of 5,993 Patient Study UPLIFT (Understanding Potential Long-term Impacts on Function with Tiotropium) Presented Today at European Respiratory Society Annual Congress
  • Not for U.S. Media
Results of the UPLIFT trial, presented today at the European
Respiratory Society (ERS) Annual Congress, demonstrated that
tiotropium  (SPIRIVA) administered to Chronic Obstructive Pulmonary
Disease  (COPD)patients, showed sustained improvements in lung
function for up to 4  years (p<0.001), although it did not alter the
rate of decline in lung  function. The landmark study also reaffirmed
the favourable safety profile of tiotropium.(1)
To view the Multimedia News Release, please click:
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UPLIFT also demonstrated that tiotropium produced a significant
delay  in time to first exacerbation by a median of 4.1 months
(p<0.001), a  significant reduction in the number of exacerbations
per patient year (14%; p<0.001). In addition, it significantly
reduced the risk of exacerbations  leading to hospitalisations
(Hazard Ratio 0.86; p<0.002) versus the control  group. Exacerbations
can worsen the clinical course of the disease, so a  treatment that
significantly reduces exacerbations can positively impact the
clinical course of COPD.(2)
UPLIFT, one of the largest COPD trials ever undertaken,involved
5,993  COPD patients from 37 countries around the globe. UPLIFT is a
landmark COPD  trial comparing tiotropium 18 microg once daily with
placebo, and allowed all  patients to continue with their normally
prescribed respiratory medications,  including dose adjustments
throughout the trial, except inhaled  anticholinergics.
Tiotropium also provided statistically significant improvements
in  health-related quality of life, as measured by the St.George's
Respiratory  Questionnaire (SGRQ, p<0.001).(*)
Throughout the four-year trial period, patients in the tiotropium
group consistently reported a better quality of life than at study
initiation.
Further, a statistically significant 16% decrease in the risk of
death (p=0.016) was observed in the tiotropium group, while patients
received  treatment. 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).
Importantly, tiotropium reduced respiratory (p<0.05) and cardiac
morbidity (p<0.05), which reaffirms the favourable safety profile of
tiotropium. As in previous studies the most commonly observed side
effect was  dry mouth.
Professor Marc Decramer, lead investigator and Professor of
Medicine at  the Catholic University Hospital in Leuven, Belgium
said: "UPLIFT 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, 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 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 percent of the patients in the  UPLIFT 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.
"The results from UPLIFT are good news, especially for primary
care  physicians who are usually the first medical contact a patient
has once they  decide to seek treatment. UPLIFT provides the
confidence that treatment  benefits of tiotropium are sustained
long-term, and COPD patients can lead  more active lives for longer,"
said Dr. Anders 0strem, MD, Specialist in Family Medicine, Oslo,
Norway and past President of International Primary Care Respiratory
Group.
UPLIFT proves tiotropium sustains positive effects for patients
with  COPD. "Patients report feeling better and the benefit seen in
survival rates  offers more hope to patients, their families, and
their physicians,"  commented Dr Andreas Barner, Vice Chairman of the
Board of Managing Directors  at Boehringer Ingelheim, responsible for
Research, Development and Medicine. "Most importantly, the four-year
study highlights the favourable safety  profile of tiotropium. Almost
6,000 patients were followed for up to four  years, adding to the
more than 10 million patient years of market experience  for
Spiriva."
Notes to Editors
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. (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(3) - more than breast cancer and
diabetes  combined.(4) Dyspnoea (breathlessness), the main symptom of
COPD, is  characteristically persistent and progressive and has a
serious impact on  patients' quality of life.(2) At its most severe,
it even limits a patient  from simple tasks such as washing and
dressing.
UPLIFT 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  microg tiotropium or placebo
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 tiotropium (SPIRIVA)
Tiotropium, a long-acting inhaled anticholinergic medication, is
the first inhaled treatment to provide significant and sustained
improvements in  lung function with once-daily dosing. Tiotropium
positively impacts the  clinical course of COPD, helping to change
the way patients live with their disease.(5),(6) It is the most
prescribed medication for the treatment of  COPD in the world.
Tiotropium works through targeting of a dominant reversible
mechanism of  COPD - cholinergic bronchoconstriction. Tiotropium
helps COPD patients  breathe easier by opening narrowed airways and
helping to keep them open for 24 hours.
Tiotropium has demonstrated significant and sustained
bronchodilation  (opening of the airways)(7) and reduction in
hyperinflation (air trapping).(8, 9) Tiotropium also demonstrated
superior and sustained improvements in lung function (FEV1) over
ipratropium bromide (ATROVENT) Inhalation Aerosol, a current
first-line therapy for COPD, which were maintained over one year (6)
and has also demonstrated superior improvement  in key lung function
parameters over salmeterol.(10) In addition, in placebo  controlled
studies, patients treated with tiotropium had less activity  induced
breathlessness and improved exercise endurance. They required fewer
doses of rescue medications, had fewer exacerbations and COPD-related
hospitalizations. (7) In clinical trials, the most common adverse
reaction  reported with tiotropium was dry mouth, which was usually
mild and often  resolved spontaneously during treatment. (7)
Long-acting bronchodilators,  including tiotropium, are a preferred
maintenance therapy for COPD from stage II onwards according to the
Global Initiative for Chronic Obstructive Lung Disease (GOLD)
treatment guidelines. (2)
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
http://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. We
discover,  develop, manufacture and deliver quality, safe and
effective prescription  medicines to treat and help prevent disease
for both people and animals. We  also partner 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 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:  ht
tp://www.boehringer-ingelheim.com/corporate/news/presspack/uplift_200
8/inde x.asp
References
(*) 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.
(1) Tashkin DP, Celli B, Senn S, et al. A 4-year trial of
tiotropium in chronic obstructive pulmonary disease. N Engl J Med
2008; 359: 1543-54.
(2) Global Initiative for Chronic Obstructive Lung Disease.
Global Strategy for the Diagnosis, Management and Prevention of
Chronic Obstructive Pulmonary Disease:
http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2=1&intId=989
Updated: 2007
(3) Source: World Health Report. World Health Organization.
Available from URL: http://www.who.int/respiratory/copd/en/
(4) World Health Organization. World Health Report 2004.
Statistical Annex. Annex table 2 and 3: 120-131.
(5) Casaburi R, Kukafka D, Cooper CB, et al. Improvement in
exercise tolerance with the combination of tiotropium and pulmonary
rehabilitation in patients with COPD. Chest 2005; 127:809-817.
(6) Vincken W, van Noord JA, Greefhorst APM, et al. Improved
health outcomes in patients with COPD during 1 year's treatment with
tiotropium. Eur Respir J 2002; 19:209-216.
(7) Casaburi R, Mahler DA, Jones PW, et al. A long-term
evaluation of once-daily inhaled tiotropium in chronic obstructive
pulmonary disease. Eur Respir J. 2002; 1:217-224.
(8) Celli B, ZuWallack R, Wang S, et al. Improvement in resting
inspiratory capacity and hyperinflation with tiotropium in COPD
patients with increased static lung volumes. Chest 2003; 124:
1743-1748.
(9) O'Donnell DE, Fluge T, Gerken F, et al. Effects of tiotropium
on lung hyperinflation, dyspnoea and exercise tolerance in COPD. Eur
Respir J. 2004 23(6):832-48
(10) Brusasco V, Hodder R, Miravitlles M, et al. Health outcomes
following treatment for six months with once daily tiotropium
compared with twice daily salmeterol in patients with COPD. Thorax
2003; 58: 399-404.
Contact:
    Boehringer Ingelheim GmbH
    External Communications
    Ute E Schmidt
    Binger Strasse 173
    55216 Ingelheim am Rhein
    Germany
    Tel.: +49-6132-779-7296
    Head External Communications
    Judith von Gordon
    Binger Strasse 173
    55216 Ingelheim am Rhein
    Germany
    Tel.: +49-6132-773-582
    E:  press@boehringer-ingelheim.com
    Pfizer Inc.
    Director European Communications
    Oliver Stohlmann
    Tel: +43-152-115-337
    E:  oliver.stohlmann@pfizer.com
    Investor Relations
    Jennifer Davis
    Tel: +1-212-733-0717
    E:  jennifer.m.davis@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; Head External Communications, Judith von Gordon,
Binger Strasse 173, 55216 Ingelheim am Rhein, Germany, Tel.:
+49-6132-773-582, E: press@boehringer-ingelheim.com; Pfizer Inc.,
Director European Communications, Oliver Stohlmann, Tel:
+43-152-115-337, E: oliver.stohlmann@pfizer.com; Investor Relations,
Jennifer Davis, Tel: +1-212-733-0717, E: jennifer.m.davis@pfizer.com