Pfizer Inc. (JOBS), Boehringer Ingelheim Corporation's Spiriva Shows Little Aid to Long-Term Lung Function

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).(x) 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)

(x) 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: http://www.boehringer-ingelheim.com/corporate/news/presspack/uplift_2008/index asp.

References

(1) UPLIFT(R) results are not currently in the SPIRIVA(R) product monograph (2) The Canadian Lung Association http://www.lung.ca/media-medias/news- nouvelles_e.php?id=98 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: http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2 =1&intId=989 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

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

Source: Pfizer Canada Inc.; Boehringer Ingelheim

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