Spiriva(R) Consistently Reduces Exacerbations And Associated Hospitalisations In Patients With COPD - Meta-Analysis Of Clinical Studies Shows

Main Category: COPD
Also Included In: Clinical Trials / Drug Trials
Article Date: 29 May 2006 - 0:00 PDT

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Patients with chronic obstructive pulmonary disease (COPD) treated with Spiriva(R) (tiotropium) for 6-12 months experienced significantly fewer exacerbations and hospitalisations compared with patients receiving placebo according to an analysis of pooled studies presented today at the International Conference of the American Thoracic Society (ATS).1 Spiriva(R) is the first and only once-daily, inhaled anticholinergic medication for maintenance treatment of COPD.

COPD is a progressive respiratory illness that causes significant deterioration of lung function and chronic breathlessness.2 600 million people worldwide already live with COPD, but its prevalence is predicted to rise to become the world's third leading cause of death by 2020.3,4 COPD exacerbations, or an acute worsening of disease symptoms, may accelerate the progression of COPD.2

"These results underline the benefit of effective treatment for patients who suffer with COPD and exacerbations," said Dr David Halpin, Consultant Physician and Senior Lecturer in Respiratory Medicine at the Royal Devon and Exeter Hospital, UK, and study investigator of the pooled analysis. "Exacerbations of COPD significantly reduce a patient's quality of life, and are a major cause of hospitalisation, disability and death. Preventing and treating exacerbations is a key goal of COPD management."

The post hoc analysis was performed on nine, completed, randomised, placebo-controlled, parallel-group Spiriva(R) studies with a duration of six months to one year.

Exacerbations were uniformly defined across all studies as an increase in, or new onset of at least two of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of three days requiring requiring treatment with antibiotics or systemic steroids, or hospitalisation. 6,171 COPD patients were included in the analysis.

Results showed, compared with placebo1:

-- Spiriva(R) significantly reduced the exposure-adjusted incidence rate of COPD exacerbations by 22.6% (65.8 vs. 85.0 per 100 patient-years; p<0.0001)

-- Spiriva(R) significantly reduced the exposure-adjusted incidence rate of associated hospitalisations by 21.3% (9.9 vs. 12.5 per 100 patient-years; p=0.011)*

-- Time to first exacerbation and hospitalisation was also prolonged with Spiriva(R) (p<0.0001).

About Spiriva(R) (tiotropium)

Spiriva(R), a long-acting inhaled anticholinergic medication, is the first inhaled treatment to provide significant and sustained improvements in lung function with once-daily dosing. Spiriva(R) 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.

Spiriva(R) works through targeting of a dominant reversible mechanism of COPD - cholinergic constriction. Spiriva(R) helps COPD patients breathe easier by opening narrowed airways and helping to keep them open for 24 hours.

The Spiriva(R) clinical trials programme has recruited over 25,000 patients.7 Spiriva(R) has demonstrated significant and sustained bronchodilation (opening of the airways)6,8 and reduction in markers of hyperinflation (air trapping).9,10 Spiriva(R) also demonstrated superior and sustained improvements in lung function (FEV1) over ATROVENT(R) (ipratropium bromide) Inhalation Aerosol, a current first-line therapy for COPD, which were maintained over one year6 and has also demonstrated superior improvement in key lung function parameters over salmeterol.11 In addition, in placebo-controlled studies, patients treated with Spiriva(R) had less activity-induced breathlessness and improved exercise endurance. They required fewer doses of rescue medications, had fewer exacerbations and COPD-related hospitalizations.8 In clinical trials, the most common adverse reaction reported with Spiriva(R) was dry mouth, which was usually mild and often resolved during treatment.6,8

According to treatment guidelines of the Global Initiative for Chronic Obstructive Lung Disease (GOLD), long-acting beta-2-agonists and tiotropium, are a preferred treatment option for COPD maintenance therapy.12

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 143 affiliates in 47 countries and almost 37,500 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 2005, Boehringer Ingelheim posted net sales of 9.5 billion euro while spending almost one fifth of net sales in its largest business segment Prescription Medicines on research and development.

* Exposure was defined as the cumulative time patients participated in the study from randomisation until the onset of exacerbation, or until discontinuation of treatment.

References

1 Halpin D, Menjoge S, Dusser D, et al. Pooled analysis of effect of tiotropium on COPD exacerbations and related hospitalisations. Abstract presented at ATS 2006, San Diego, USA. 19-24 May 2006.
2 Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease. Executive Summary. GOLD website (http://www.goldcopd.com). Updated 2005.
3 World Health Organization. World Health Report 2004. Statistical Annex. Annex table 2 and 3: 120-131.
4 Murray CJL, Lopez AD. eds. The Global Burden of Disease: a comprehensive assessment of mortality and disability from diseases, injuries, and risk factors in 1990 and projected to 2020. Cambridge; Harvard University Press; 1996.
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 tiotopium. Eur Respir J 2002; 19:209-216.
7 Boehringer Ingelheim. Data on file.
8 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.
9 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.
10 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
11 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.
12 Pocket Guide to COPD diagnosis, management, and prevention - A guide for healthcare professionals. Global Initiative for Chronic Obstructive Lung Disease. Available at: http://www.goldcopd.com

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