SPIRIVA®* celebrates 10 years of ongoing commitment to patients and advancing clinical innovation in COPD

Coinciding with the annual European Respiratory Society Congress, ERS 2012, SPIRIVA® (tiotropium), the first once-daily long-acting inhaled anticholinergic maintenance treatment for patients with Chronic Obstructive Pulmonary Disease (COPD) will mark its 10th anniversary since launch.* With over 25 million patient years of experience†, once-daily SPIRIVA® is the most prescribed COPD maintenance treatment worldwide.1,2 This unique position is rooted in the wealth of clinical trial data available to prove tiotropium’s clinical efficacy in reducing breathlessness (dyspnoea) and the risk of exacerbations as well as improving patients’ quality of life.3,4,5,6 Over the years, more than 175 clinical trials with tiotropium in COPD have been conducted investigating a broad range of patients in studies of up to four years.7

“What is important to note is that from the first COPD patients to receive SPIRIVA® over ten years ago, to the thousands who are currently prescribed it every day, SPIRIVA® has made a significant and lasting contribution to our scientific understanding and management of COPD,” said Professor Antonio Anzueto, Professor of Medicine Pulmonary/Critical Care Medicine, University of Texas Health Science Center at San Antonio, Texas, USA. “This has been chronicled through evidence from large scale clinical trials, notably UPLIFT®‡ and POET-COPD®§ , which prove the efficacy of SPIRIVA® in reducing the risk of exacerbations, improving lung function, reducing shortness of breath and increasing patient quality of life.”

SPIRIVA® reduces the risk of exacerbations and improves lung function in low risk patients as defined by the new GOLD** COPD Patient Group criteria8

Data presented at ERS 2012 provide further evidence from one of the pivotal long-term SPIRIVA® trials, UPLIFT®‡9, demonstrating a reduced risk of exacerbations with SPIRIVA® in low risk COPD patients (GOLD Patient Groups A and B). This adds to the body of evidence that SPIRIVA® reduces the risk of exacerbations in all GOLD Patient Groups.9,3

In the analysis of the UPLIFT® trial presented at ERS 2012, the study investigators showed that in low risk COPD patients:8

• The hazard ratio(tiotropium vs. control) for time to first exacerbation was significantly improved; 0.76 (95% CI, 0.68; 0.86; P<0.0001) as were mean annual exacerbation rates with 0.43 (95% CI, 0.40; 0.48) vs. 0.61 (0.56; 0.66), rate ratio 0.72 (0.63; 0.81; P<0.0001)
• The St George’s Respiratory Questionnaire (SGRQ) †† total score after four years was significantly improved by tiotropium vs. placebo: −3.63 (95% CI, −5.14; −2.12; P<0.0001)
• The respective increase for trough FEV 1 was 110 mL for tiotropium (95% CI, 84; 136; P<0.0001)

In its recent report “Global Strategy for Diagnosis, Management, and Prevention of COPD”, GOLD extensively revised their COPD severity classification to focus on the evaluation of exacerbation risk as well as analysis of COPD symptoms. This new evaluation now not only includes spirometry tests but also a combination of a patient’s severity of symptoms and a history of exacerbations. The new Global Initiative for Chronic Obstructive Lung Disease (GOLD) report recommends long-acting anticholinergics for every patient requiring maintenance therapy (first choice for Patient Groups B-D and second option for Patient Group A).10 This recommendation was based on data for the long acting anticholinergic tiotropium.

Professor Dr. Claus Vogelmeier, Professor of Medicine and Head of Pulmonary Division, Marburg University Hospital, Marburg, Germany said, “With a new emphasis in the updated GOLD report on managing exacerbations, SPIRIVA® meets the criteria for all GOLD Patient Group COPD patients requiring maintenance therapy, including a positive effect on risk reduction of exacerbations. Reduction of exacerbations is key to improvement in COPD patient status as they have a major impact on patients’ quality of life and often lead to hospitalisation.”

“The data from the ERS Congress add further weight to COPD patient benefits as a result of tiotropium treatment, particularly the positive impact on exacerbations, quality of life and improved lung function,” said Dr. Marc Miravitlles, Chest Physician and Senior Researcher, Department of Pneumology, Hospital Clinic, Barcelona, Spain. “COPD remains a debilitating, progressive and under-recognised lung disease and it is important that the most widely prescribed COPD treatment is central to future prospects for advancing treatment for the millions of patients with this condition.”

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.‡‡10 The 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 200511 – more than breast cancer and diabetes combined.12 Dyspnoea (breathlessness), the main symptom of COPD, is characteristically persistent and progressive and has a serious impact on patients’ quality of life.10 At its most severe, it even limits a patient from performing simple tasks such as washing and dressing.

About SPIRIVA® (tiotropium)

SPIRIVA®, a long-acting anticholinergic medication, is the first inhaled maintenance 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.4,13 It is the most prescribed maintenance therapy for COPD worldwide. SPIRIVA® helps COPD patients breathe more easily 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)14 and reduction in hyperinflation (air trapping).6,15 In placebo-controlled studies, patients treated with SPIRIVA® had less activity-induced breathlessness and improved exercise endurance.4 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.9§§ These benefits were shown in a broad range of COPD severities, including patients with early-stage COPD (GOLD Patient Groups A and B),16§§ patients new to maintenance therapy,17§§ and younger patients (<50 years of age).

In clinical trials SPIRIVA® demonstrated a favourable safety profile. The most common adverse reaction reported with SPIRIVA® was dry mouth, which was usually mild and often resolved spontaneously during treatment.14 Long-acting bronchodilators, including SPIRIVA®, are a preferred maintenance therapy for COPD (first choice for Patient Groups B-D and second option for Patient Group A), according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) treatment report.10

A pivotal SPIRIVA® study, relating to COPD exacerbations, is the POET-COPD® study. This was a large one year head-to-head study, that demonstrated once-daily SPIRIVA® 18 µg delivered via HandiHaler® reduced the risk of a first moderate to severe exacerbation by 17 percent (p<0.001) and of a first severe exacerbation requiring hospitalisation by 28 percent (p<0.001) compared to the long acting beta agonist twice-daily salmeterol (50 µg via HFA-pMDI).3

SPIRIVA® is delivered via HandiHaler®, a breath-actuated, single-dose dry powder inhaler, or by SPIRIVA® Respimat® Soft Mist Inhaler™ propellant-free, new generation inhaler that combines innovative technology with the proven efficacy of SPIRIVA®.

* First introduced to the market via HandiHaler® in 2002

† Combined figures for HandiHaler® and Respimat®

‡ While SPIRIVA® 18 μg via HandiHaler® did not alter the rate of decline in lung function, a coprimary study endpoint in the UPLIFT® study, it sustained greater improvements in lung function vs. placebo

§ SPIRIVA® 18 μg delivered via HandiHaler®

**GOLD –Global Initiative for Chronic Obstructive Lung Disease

††St George’s Respiratory Questionnaire is a recognised indicator of health-related quality of life, measuring impairment on a scale of 0 to 100. Minimal Clinically Important Difference in SGRQ is defined as 4 units

‡‡Increased exacerbation risk is typically defined by a FEV 1 of <50% pred and/or ≥2 exacerbations in the previous year (GOLD C+D) and low risk by a FEV 1 ≥50% pred and 0-1 exacerbation in the previous year (GOLD A+B).

§§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

1. Boehringer Ingelheim. Data on file.

2. IMS Health, IMS MIDAS(™), Q2 2012.

3. Vogelmeier C, Hederer B, Glaab T, et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med 2011;364(12):1093-1103.

4. 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.

5. Anzueto A, Tashkin D, Menjoge S, Kesten S. One-year analysis of longitudinal changes in spirometry in patients with COPD receiving tiotropium. Pulm Pharmacol Ther 2005;18:75-81.

6. Celli B, ZuWallack R, Wang S, Kesten S. Improvement in resting inspiratory capacity and hyperinflation with tiotropium in COPD patients with increased static lung volumes. Chest 2003;124:1743-1748.

7. 8. Halpin D, Decramer M, Celli B et al. Effectiveness of tiotropium in low-risk patients according to new GOLD severity grading. ERS 2012 Poster P2190 Thematic Poster Session 249: Translational respiratory medicine in asthma and COPD. 12:50 – 14:40 Monday 3 September 2012, Vienna, Austria.

9. Tashkin DP, Celli B, Senn S, et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008;359:1543-1554.

10. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease. 2011. http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2=1&intId=989. (Accessed: August 2012).

11. World Health Organization. Global Alliance Against Chronic Respiratory Diseases. http://www.who.int/mediacentre/factsheets/fs315/en/index.html. (Accessed 10 December 2010).

12. World Health Organization. World Health Report 2004. Statistical Annex. Annex table 2 and 3:120-131.

13. 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.

14. 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.

15. 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.

16. Decramer 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.

17. Troosters 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.