New data show SPIRIVA® significantly reduces COPD exacerbations and related health resource burden

September 07, 2004

GLASGOW, UNITED KINGDOM, Tuesday 7 September - SPIRIVA® (tiotropium) significantly reduced exacerbations and health resource utilization compared with placebo in patients with Chronic Obstructive Pulmonary Disease (COPD), according to data presented today at the annual European Respiratory Society meeting in Glasgow, Scotland.1,2 SPIRIVA® is a novel, inhaled, anticholinergic medication with 24-hour efficacy3 recommended for maintenance treatment of COPD. SPIRIVA® provides superior symptom relief and sustained improvement in lung function vs placebo so that patients with COPD can regain a better quality of life.3-5

COPD is a progressive respiratory disease that causes significant deterioration of lung function and chronic breathlessness, which can lead to severe disability.6 Chronic airflow limitation associated with COPD leads to excess air being trapped in the lungs after a person has fully exhaled. This condition, known as "air trapping", is a primary cause of breathlessness, which often restricts a patient's ability to perform daily activities such as walking up stairs or taking a shower.3,7 Currently, COPD is the fourth leading cause of death worldwide, claiming 2.75 million lives annually.8

"Current guidelines state that exacerbations, or acute worsening of disease symptoms, are a key target for COPD therapy because they severely impact quality of life, and are responsible for the majority of healthcare costs associated with treating COPD," said Professor Daniel Dusser, Head of Pneumology, Hôpital Cochin, Paris and principal study investigator.

In this one-year, placebo-controlled study involving 1,010 patients with COPD in 177 centres in France, SPIRIVA® was shown to significantly reduce the frequency of exacerbations compared to placebo (1.57 vs 2.41 per patient per year, -35%, p<0.01).1 The average number of exacerbation days was significantly lower with SPIRIVA® compared to placebo (21.1 vs 33.3 per patient per year, -37%, p<0.01), and the time to first exacerbation was also significantly prolonged (p<0.001).1

The reduction in exacerbations with SPIRIVA® was also associated with significantly lower health resource utilization.2 The following was observed compared to placebo:"The results of this study reinforce the effectiveness of SPIRIVA® as a maintenance therapy that significantly reduces COPD exacerbations, improving patient quality of life and reducing the related burden on health resources," Professor Daniel Dusser said.

In this study, exacerbations were defined as the onset of ³1 clinical symptom in the past 24 hours (worsening of dyspnoea, cough or sputum production; appearance of purulent sputum; fever [>38°C] or appearance of new chest X-ray abnormality) requiring a new prescription, or an increase in the dose, of b2-agonists, antibiotics, corticosteroids or bronchodilators.

About SPIRIVA® (tiotropium)
SPIRIVA®, an inhaled anticholinergic medication, is the first inhaled treatment to provide significant and sustained improvements in lung function, with once-daily dosing. SPIRIVA® works through targeting of a dominant reversible mechanism of COPD - cholinergic bronchoconstriction. SPIRIVA® helps COPD patients breathe more easily by opening narrowed airways and helping to keep them open for 24 hours. According to treatment guidelines of the Global Initiative for Chronic Obstructive Lung Disease (GOLD), long-acting bronchodilators, including tiotropium, are a preferred treatment option for COPD maintenance therapy.

The SPIRIVA® clinical trials programme has recruited over 9,400 patients.9 SPIRIVA® has demonstrated significant and sustained bronchodilation (expansion of the lungs airways). 10-12 SPIRIVA® also demonstrated improvements in lung function (FEV1) vs ATROVENT® (ipratropium bromide inhalation aerosol), a current first-line therapy for COPD, which were maintained over one year.10,11 In addition, in one-year, placebo-controlled studies, patients treated with SPIRIVA® required fewer doses of rescue medications.12

In clinical trials, the most common adverse reaction reported with SPIRIVA® was dry mouth, which was usually mild and often resolved during treatment.10-12
-end-
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 152 affiliates in 45 countries and more than 34,000 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 2003, Boehringer Ingelheim posted net sales of 7.4 billion euro while spending more than 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
Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines for humans and animals, and many of the world's best-known consumer products. For further information on Pfizer, please see www.pfizer.com

Contact:

Boehringer Ingelheim GmbH
Judith von Gordon
Corporate Division Communications
55216 Ingelheim am Rhein
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References

1. Dusser D, Bravo ML, Iacono P. Tiotropium reduces COPD exacerbations : The MISTRALstudy. Abstract presented at ERS 2004, Glasgow, Scotland. 4-8 September 2004.
2. Dusser D, Bravo ML, Iacono P. Tiotropium reduces health resource utilization associated with COPD exacerbations. Abstract presented at ERS 2004, Glasgow, Scotland. 4-8 September 2004.
3. Celli B, Zu, Wallack 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.
4. Vincken W, van Noord JA, Greefhorst APM, et al. Improved health outcomes in patients with COPD during 1 yr's treatment with tiotropium. European Respiratory Journal 2002; 19:209-216.
5. Casaburi R, Mahler DA, Jones PW, et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. European Respiratory Journal 2002; 19:217-224.
6. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease: NHLBI/WHO Workshop Report . National Institute of Health; 2001. NIH Publication No. 2701 Available at http://www.goldcopd.com.
7. Mahler DA. How should health related quality of life be assessed in patients with COPD? Chest 2000; 117:54 S-57S.
8. World Health Organization. World Health Report 2003. Statistical Annex. Annex table 2: 154-159.
9. Boehringer Ingelheim. Data on file.
10. Vincken W, van Noord JA, Greefhorst APM, et al. Improved health outcomes in patients with COPD during 1 yr's treatment with tiotropium. European Respiratory Journal 2002; 19:209-216.
11. Van Noord JA, Smeets JJ, Custers FJL, et al. Pharmacodynamic steady state of tiotropium in patients with chronic obstructive pulmonary disease. European Respiratory Journal 2002; 19:639-644.
12. Casaburi R, Mahler DA, Jones PW, et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. European Respiratory Journal 2002; 19:217-224.

Shire Health International

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