Boehringer Ingelheim & Pfizer

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: http://www.prnewswire.com/mnr/uplift/35106/

    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

ots Originaltext: Boehringer Ingelheim & Pfizer
Im Internet recherchierbar: http://www.presseportal.ch

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



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