New Report Highlights Increased Importance of Risk Reduction in Chronic Obstructive Pulmonary Disease (COPD) Management

- New Expert Report on COPD Launched at a Press Conference at ERS 2012 -

VIENNA, Sept. 2, 2012 /CNW/ - Takeda today announced the launch of a new expert Report on COPD, introduced at a Takeda organised press conference on the occasion of the 2012 European Respiratory Society (ERS) Annual Congress taking place from 1- 5 September in Vienna, Austria.

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The Report, entitled 'The Shifting Paradigm in Chronic Obstructive Pulmonary Disease (COPD) Management,' was initiated and developed by Takeda Pharmaceuticals International GmbH and is a compilation of opinion articles from a panel of key international respiratory experts, the European Federation of Allergy and Airways Diseases Patients' Association (EFA) and COPD patients, reflecting updated guidance and research. The new expert Report was developed in response to a recent shift in emphasis in COPD management which now places future risk at equal importance to treatment of current disability.^[1] Treatment objectives are now divided into two groups: reducing symptoms and reducing risk. ^[1]

Speaking at the launch of the new expert Report Dr Alan Kaplan, Chairperson of the Respiratory Medicine Special Interest Focus Group of the College of Family Physicians of Canada, said: "The management of stable COPD should, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD), be based on a combined assessment of both the current symptom burden as well as the future risk of disease progression. The importance of prevention is well established in many other diseases, including cardiovascular disease, and it is essential that we recognise and target this in COPD. The new expert Report aims to support healthcare professionals at every level within respiratory care, including GPs, nurses and consultants; providing suggestions and guidance to help them in making more informed decisions and provide enhanced care and counsel to COPD patients to improve their outcomes."

The shifting paradigm in COPD management is considered within the new expert Report, alongside why an increased focus on future risk is so important. This includes a review of what lessons can be learned from the cardiovascular arena with regard to implementing a predictive and personalised risk assessment as routine practice, the importance and impact of a positive patient-physician relationship with regard to maintaining adherence to interventions that provide long-term rather than immediate benefits, as well as a focus on the pharmacological and non-pharmacological interventions available to support this shift in COPD management.

Whilst there is no data yet showing the effect of different therapeutic interventions in the patient categories as defined by the new GOLD assessment algorithm (A-D), the novel anti-inflammatory agent, roflumilast, has been shown to provide significant reductions in moderate/severe exacerbations when added to bronchodilators in patients with COPD-associated chronic bronchitis, severe lung function impairment and a history of frequent exacerbations (GOLD category D). ^[2] The new expert Report draws on a post-hoc analysis presented at ERS 2012, which suggests that roflumilast significantly reduces exacerbations when added to tiotropium in symptomatic COPD patients with moderate to severe lung function impairment and a baseline mMRC grade ≥2 (GOLD category B and D) by 45 percent. ^[3]

COPD is an important cause of death, illness and healthcare costs worldwide, affecting about 210 million people and a leading cause of morbidity and mortality. By 2030, COPD will be the third largest killer in the world. ^[4]

Reducing the number of exacerbations experienced by patients is still a major unmet need in COPD and figures show that up to half of exacerbations are not reported by patients. ^[5] COPD exacerbations are the most important determinants of health status in COPD^[5] and are important targets for therapies both from the point of view of treating the event and prevention.

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Notes to editors:

About COPD

A copy of the new expert Report and COPD backgrounder are available upon request.

About the new expert Report on COPD authors

The expert Report on COPD brings together key stakeholders within respiratory care:

• Dr Ondrej Rybnicek, European Federation of Allergy and Airways Diseases Patients' Association (EFA)
• Dr Stephen Rennard, Larson Professor of Medicine, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska
• Prof Andrew McIvor, Professor of Medicine, McMaster University, Canada
• Dr Alan Kaplan, Chairperson, Respiratory Medicine Special Interest Focus Group, College of Family Physicians of Canada
• Prof Wisia Wedzicha, Professor of Respiratory Medicine, Centre for Respiratory Medicine, UniversityCollegeLondon
• Prof Robert Horne, Professor of Behavioural Medicine, UCLSchool of Pharmacy, Head of the Department of Practice and Policy, and Director of the Centre for Behavioural Medicine
• The European Federation of Allergy and Airways Diseases Patients' Associations (EFA), a European network of allergy, asthma and COPD patient organisations. EFA serves the interests of patients by providing information, education, peer contact and financial support. http://www.efanet.org/

About Roflumilast

Roflumilast is the first anti-inflammatory treatment developed to target COPD-specific inflammation with a novel mode of action. Its active component, roflumilast, is a potent and selective inhibitor of the PDE4 enzyme. ^[6]

Four large randomised placebo controlled trials have shown that roflumilast significantly reduces exacerbations and improves lung function when added to long acting bronchodilators. ^[7,8,9]

Roflumilast is indicated in the EU for the maintenance treatment of severe COPD (FEV₁ post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as an add-on to bronchodilator treatment. ^[10]

Clinical COPD trials involved more than 12,000 patients. Roflumilast was generally well tolerated. The most commonly reported adverse reactions were diarrhoea (5.9%), weight decreased (3.4%), nausea (2.9%), abdominal pain (1.9%) and headache (1.7%). The majority of these adverse reactions were mild or moderate. These adverse reactions mainly occurred within the first weeks of therapy and mostly resolved on continued treatment. ^[10]

About Takeda Pharmaceuticals International GmbH

Takeda Pharmaceuticals International GmbH headquartered in Zurich, is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited located in Osaka, Japan. Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, http://www.takeda.com.

This press release has been issued by Takeda Pharmaceuticals International GmbH, Thurgauerstrasse 130, CH-8152 Glattpark-Opfikon (Zurich), Switzerland

1. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011. http://www.goldcopd.org (accessed July 2012).
2. Bateman ED, Rabe KF, Calverley PM, et al. Roflumilast with long-acting beta 2-agonists for COPD: influence of exacerbation history, Eur Respir J 2011;38:553-560.
3. Fabbri LM, et al. Effects of roflumilast in highly symptomatic COPD patients [abstract]. In: European Respiratory Society's 22nd Annual Congress; 2012 Sept 1-5; Vienna, Austria: ERS; 2012. Abstract P742.
4. World Health Organization. COPD. Fact Sheet No 315. 2008. http://www.who.int/mediacentre/factsheets/fs315/en/index.html (accessed June 2012)
5. Seemungal TAR, Donaldson GC, Paul EA,Bestall JC, Jeffries DJ, Wedzicha JA. Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 1998;157:1418-1422
6. Hatzelmann A, et al. The preclinical pharmacology of roflumilast - a selective, oral phosphodiesterase 4 inhibitor in development for chronic obstructive pulmonary disease, Pulm Pharm Ther 2010;23:235-256.
7. Calverley PMA, et al. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet 2009; 374: 685-94.
8. Fabbri LM, et al. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with long-acting bronchodilators: two randomised clinical trials. Lancet 2009;374:695-703.
9. Rabe KF. Update on roflumilast, a phosphodiesterase 4 inhibitor for the treatment of chronic obstructive pulmonary disease. Br J Pharm 2011;163:53-67.
10. EU Summary of Product Characteristics, Daxas®, May 2011 (available at http://www.ema.europa.eu)

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SOURCE: Takeda Pharmaceuticals International GmbH

For further information:

Fleishman-Hillard , Cheryl Pitcher, Tel: [phone] , Email: [e-mail] ;
Takeda Pharmaceuticals International GmbH, Tobias Cottman, Tel: [phone]