Value through Innovation20 September 2014
23 March 2011

The POET-COPD® study results demonstrate superiority of Spiriva® (tiotropium) over long-acting beta agonist salmeterol in reducing the risk for COPD exacerbations

Head-to-head study shows significantly better outcomes with Spiriva® (tiotropium) in reducing COPD exacerbations compared to salmeterol

Ingelheim am Rhein, Germany / New York, N.Y., USA (24 March 2011) – Results of the one-year Prevention Of Exacerbations with Tiotropium in COPD (POET-COPD®) study, published today by the New England Journal of Medicine (NEJM), demonstrate that Spiriva® (tiotropium)*, is superior to salmeterol**, in reducing the risk of exacerbations in Chronic Obstructive Pulmonary Disease (COPD).1 The POET-COPD® study is a large, one year head-to-head study designed to compare the effects of the long-acting anticholinergic Spiriva® with the long-acting beta agonist salmeterol on moderate to severe exacerbations in COPD.1 Exacerbations (sometimes referred to as COPD lung attacks due to the severe impact on patients’ health), are a key indicator for disease progression and decline in lung function and their prevention is a major treatment goal.2,3,4

Results of the POET-COPD® Study

The results of the POET-COPD® study, which involved 7376 patients with moderate to severe COPD and a history of exacerbations, show that Spiriva® significantly delayed the occurrence of the first COPD exacerbation. A 17 percent overall risk reduction (p<0.001) versus salmeterol was observed.

Spiriva® reduced the risk of first moderate exacerbation by 14 percent (p<0.001) and of first severe exacerbation requiring hospitalisation by 28 percent (p<0.001) compared to the long acting beta agonist salmeterol.1

Prof. Dr Claus Vogelmeier

Prof. Dr Claus Vogelmeier

Commenting on the findings of the POET-COPD® study, lead investigator Professor Dr. Claus Vogelmeier, Department of Internal Medicine, Division of Pulmonary Diseases, University of Marburg, Germany said, “Exacerbations have a substantial impact on patients’ quality of life, morbidity and increase the risk of death. This large exacerbation trial supports the use of tiotropium as a first choice for maintenance treatment in COPD to help minimise the risk of exacerbations from early on, enabling patients to lead active lives for longer.”

There were 4411 exacerbations among 2691 patients in the study, and 44 percent of the patients with an exacerbation were in moderate (e.g. GOLD*** Stage II) COPD.1 The effects of Spiriva® on time to first exacerbation and annual rate of exacerbations per patient were consistent over all pre-specified subgroup analyses for age, sex, smoking status, COPD severity (GOLD Stage), body mass index, and use of inhaled corticosteroids at baseline. Furthermore, the benefit of Spiriva® compared with the long-acting beta agonist salmeterol became apparent as early as one month after onset of treatment and was maintained over the one-year study period.1

The POET-COPD® safety analyses confirm the safety profiles of Spiriva® and salmeterol as previously described. 5,6,7,8

The rates of serious adverse events, adverse events leading to treatment discontinuation, and fatal adverse events were similar between both treatments.1

COPD Exacerbations

COPD exacerbations (sometimes referred to as COPD lung attacks) are an acute worsening of COPD symptoms and have a severe impact on patients’ health. Frequent exacerbations indicate a deterioration and progression of the disease.2,3,4 They are associated with a more rapid decline in lung function over time and, in severe cases, an increased risk of mortality, and they can severely compromise patients’ health-related quality of life.2,3,4 Economic analyses suggest that hospitalisation due to COPD exacerbations accounts for 40-70 percent of all medical expenses for patients with COPD.9,10,11,12 The cost of hospitalisation for COPD patients is estimated at $ 6.1 billion in the U.S.A. alone.12 As hospitalisation accounts for the largest component of cost in the management of COPD, interventions reducing hospitalisation will have the greatest impact on the cost of treating COPD for all severities of the disease.9

The POET-COPD® study was a one-year, randomised, double-blind, double-dummy, parallel-group trial involving 7376 patients with moderate to severe COPD from 25 countries in 725 centres.1 The study was specifically designed to compare the effects on exacerbations of two long-acting bronchodilators; both are recommended as maintenance therapy of COPD by international guidelines and are widely used.13,14

Prof. Dr. Klaus Rabe

Prof. Dr. Klaus Rabe

“COPD exacerbations can occur even in the early stages of COPD (e.g. GOLD Stage II) and may recur throughout the course of the disease. They are associated with substantial personal, medical, societal and economic burden. Prevention of exacerbations constitutes a major treatment goal and is a key concern for COPD patients”, said Professor Dr. Klaus Rabe, Department of Medicine, University of Kiel and Grosshansdorf Hospital, Germany. “The results of the POET-COPD® study, comparing two long-acting bronchodilators, should help to guide clinical practice in the management of COPD and the prevention of exacerbations.”

To view a press briefing webcast and access related background materials please visit http://boehringer-ingelheim-webcast.com/spiriva/

Notes to Editors

About COPD

Chronic Obstructive Pulmonary Disease (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. Acute worsening of these symptoms, i.e. exacerbations (sometimes referred to as COPD lung attacks due to their severe impact on patients’ health) often occur and can restrict a patient’s ability to perform normal daily activities.13 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 200515 – more than breast cancer and diabetes combined.16 Dyspnoea (breathlessness), the main symptom of COPD, is characteristically persistent and progressive and has a serious impact on patients’ quality of life.13 At its most severe, it even limits a patient from performing simple tasks such as washing and dressing.

About the POET-COPD® Study

The Prevention Of Exacerbations with Tiotropium in COPD (POET-COPD®) study was a one-year, multicentre (725 sites), multinational (25 countries), randomised, double-blind, double-dummy, parallel-group trial which included 7376 male and female COPD patients. The primary objective of this study was to compare the effect of Spiriva® (18 µg) inhalation capsule via HandiHaler® and salmeterol (50 µg) via HFA metered dose inhaler (MDI) on COPD exacerbations.1

Patients included in the trial had to be ≥40 years of age, have a smoking history of ≥10 pack-years and a diagnosis of moderate to very severe COPD with a history of at least one exacerbation within the previous year requiring treatment with either systemic steroids and/or antibiotics or hospitalisation.1

About Spiriva® (tiotropium)

Spiriva®, 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® positively impacts the clinical course of COPD, helping to change the way patients live with their disease.17,18 It is the most prescribed maintenance therapy for COPD worldwide. Spiriva® helps COPD patients breathe easier by opening narrowed airways and helping to keep them open for 24 hours. Spiriva® works through targeting of a dominant reversible mechanism of COPD – cholinergic bronchoconstriction.

Spiriva® has demonstrated significant and sustained bronchodilation (opening of the airways)19 and reduction in hyperinflation (air trapping).20,21 In placebo-controlled studies, patients treated with Spiriva® had less activity-induced breathlessness and improved exercise endurance.17
In the UPLIFT® trial, Spiriva® demonstrated proven benefits for up to four years including improved lung function and quality of life as well as reduced exacerbations and COPD-related hospitalisations.22 + These benefits were shown in a broad range of COPD severities, including patients with early-stage COPD (GOLD Stage II),23 + patients new to maintenance therapy 24+ and younger patients (<50 years of age).

In clinical trials, the most common adverse reaction reported with Spiriva® was dry mouth, which was usually mild and often resolved spontaneously during treatment.19 In the 4-year UPLIFT® trial, Spiriva® demonstrated a favourable safety profile, and a beneficial impact on respiratory/cardiovascular co-morbidity, as well as on mortality.22 Long-acting bronchodilators, including Spiriva® are a preferred maintenance therapy for COPD from stage II onwards, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) treatment guidelines.13

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 142 affiliates in 50 countries and more than 41,500 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 2009, Boehringer Ingelheim posted net sales of 12.7 billion euro while spending 21 percent of net sales in its largest business segment Prescription Medicines on research and development.

For more information please visit www.boehringer-ingelheim.com

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*    Via HandiHaler® 
**  Via HFA(metered-dose inhaler)
***Global Initiative for Chronic Obstructive Lung Disease
  
+In the UPLIFT® trial, Spiriva® did not alter the rate of decline in lung function in the overall clinical trial population, which was the primary end point (Spiriva® delivered via HandiHaler®).

References
1Vogelmeier C, Hederer B, Glaab T, et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med 2011;364(12)
2Donaldson GC, Seemungal TAR, Bhowmik A, et al. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax 2002;57:847–52.
3Soler-Cataluña JJ, Martínez-García MÁ, Román Sánchez P, et al. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax 2005;60:925–31.
4Wedzicha JA, Seemungal TA. COPD exacerbations: defining their cause and prevention. Lancet 2007;370:786–96.
5Celli B, Decramer M, Leimer I, et al. Cardiovascular safety of tiotropium in patients with COPD. Chest 2010;137:20-30.
6Kesten S, Celli B, Decramer M, et al. Tiotropium HandiHaler® in the treatment of COPD: A safety review. Int J COPD 2009;4:397-409.
7Ferguson GT, Funck-Brentano C, Fischer T, et al. Cardiovascular safety of salmeterol in COPD. Chest 2003;123:1817-24.
8Rodrigo GJ, Moral VP, Marcos LG, et al. Safety of regular use of long-acting beta agonists as monotherapy or added to inhaled corticosteroids in asthma. A systematic review. Pulm Pharmacol Ther 2009;22:9-19.
9Hilleman DE, Dewan N, Malesker M, et al. Pharmacoeconomic evaluation of COPD. Chest 2000;118(5)1278-1285.
10Strassels SA, Smith DH, Sullivan SD, et al. The costs of treating COPD in the United States. Chest 2001;119(2):344-352.
11Rodriguez-Roisin R. Impacting patient-centred outcomes in COPD: exacerbations and hospitalizations. Eur Respir Rev 2006; 15: 99, 47–50.
12Chapman KR, Mannino DM, Soriano JB, et al. Epidemiology and costs of chronic obstructive pulmonary disease. Eur Respir J 2006;27:188–207.
13Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease. Updated 2009. http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2=1&intId=2003. (Accessed 10 December 2010).
14American Thoracic Society and European Respiratory Society. Standards for the Diagnosis and Management of Patients with COPD. 2004. http://www.copd-ats-ers.org/copddoc.pdf. (Accessed: 10 December 2010).
15World Health Organisation. Global Alliance Against Chronic Respiratory Diseases. http://www.who.int/mediacentre/factsheets/fs315/en/index.html. (Accessed 10 December 2010).
16World Health Organization. World Health Report 2004. Statistical Annex. Annex table 2 and 3: 120-131.
17Casaburi 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.
18Vincken 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.
19Casaburi 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.
20Celli 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.
21O'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.
22Tashkin DP, Celli B, Senn S, et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008;359:1543-1554.
23Decramer M, Celli B, Kesten S, et al. Effect of tiotropium on outcomes in patients with moderate chronic obstructive pulmonary disease (UPLIFT): a prespecified subgroup analysis of a randomized controlled trial. Lancet 2009;374:1171-78.
24Troosters T, Celli B, Lystig T, et al. Tiotropium as a first maintenance drug in COPD: secondary analysis of the UPLIFT® trial. Eur Respir J 2010;36:65-73.

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Prof. Dr Claus Vogelmeier

What is POET-COPD?

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