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<PRNewswire> 만성폐쇄성폐질환 (COPD) 관리에서위험감소중요성을강조 - ERS 2012 기자회견에서발표된새로운만성폐쇄성폐질환 (COPD) 전문가보고서 - ( 빈 2012 년 9 월 2 일 PRNewswire= 연합뉴스 ) 28 일, Takeda 가 9 월 1-5 일오스트리아빈에서열리는 2012 유럽호흡기학회 (European Respiratory Society, ERS) 연례회의관련기자회견에서만성폐쇄성폐질환 (COPD) 의새로운전문가보고서를발표했다. 멀티미디어배포자료는아래웹사이트에서확인할수있다. http://www.multivu.com/mnr/56582-expert-report-on-copd-launch 만성폐쇄성폐질환 (Chronic Obstructive Pulmonary Disease, COPD) 관리의패러다임전환 이라고명명된이보고서는 Takeda Pharmaceuticals International GmbH 이작성했으며, 주요국제호흡기전문가, 유럽알러지및기도질환환자연맹 (European Federation of Allergy and Airways Diseases Patients' Association, EFA) 및만성폐쇄성폐질환 (COPD) 환자들로구성된패널의평가논문들로구성돼갱신된안내와연구를반영한다. 이새로운전문가보고서는최근만성폐쇄성폐질환 (COPD) 관리의역점변화에대응해서작성됐다. 현재만성폐쇄성폐질환 (COPD) 는현재질환치료만큼이나미래위험감소에역점을두고있다.[1] 치료목적은대체로증상감소와위험감소두부분으로나뉜다.[1] 새로운전문가보고서발표와관련해 College of Family Physicians of Canada 의호흡기의학특별관심포커스그룹의장인 Dr Alan Kaplan 은 GOLD(Global Initiative for Chronic Obstructive Lung Disease) 에의하면, 안정적인만성폐쇄성폐질환 (COPD) 관리는현재증상은물론미래질환경과위험평가를바탕으로해야한다 면서 심혈관질환을포함해수많은다른질병에서이미예방의중요성이잘알려져있다. 따라서만성폐쇄성폐질환 (COPD) 에서도예방의중요성을인정하고, 예방을목표로하는것이중요하다. 새로운전문가보고서의목적은 GP, 간호사및컨설턴트를포함해호흡기관리부문내모든건강관리전문가들을지원하고, 이들이좀더정보에기반한결정을내리고, 경과를향상시킬수있는향상된관리와조언을만성폐쇄성폐질환 (COPD) 환자들에게제공하도록제안과안내를하는것 이라고말했다. 새로운전문가보고서는만성폐쇄성폐질환 (COPD) 관리패러다임전환과더불어미래위험에더욱초점을맞추는것이왜중요한지다루고있다. 일상적인관행으로서예방적이고개인화된위험평가실행과관련해심혈관질환부문에서배울수있는교훈, 즉각적인효과보다는지속적인효과를제공하는중재유지와관련해긍정적인환자 - 의사관계의중요성과영향및만성폐쇄성폐질환 (COPD) 관리패러다임전환을지원하기위한제약및비제약중재등을검토하고있다. 새로운 GOLD 평가알고리듬 (A-D) 에서정의한환자부류에서다양한치료중재의효과를증명하는자료는아직나오지않았지만, 새로운항염증제 roflumilast 을기관지확장제와함께만성폐쇄성폐질환 (COPD) 관련만성기관지염, 중증폐기능손상및자주악화가발생하는 (GOLD 의 D 부류 ) 환자에처방할경우중등도 / 중증악화가유의하게감소하는것으로나타났다.[2] 새로운전문가보고서는 ERS 2012 에서발표된사후분석도바탕으로한다. 이사후분석에따르면, 중등도에서중증폐기능손상에기준선 mmrc 등급 2 (GOLD 의 B 와 D 부류 ) 인증후성만성폐쇄성폐질환 (COPD) 환자에 tiotropium 와더불어 roflumilast 를처방할경우, 악화가 45% 유의하게감소됐다고한다.[3] 만성폐쇄성폐질환 (COPD) 는전세계적으로사망, 질병및건강관리비용을발생시키는주요원인으로서약 2 억 1 천만명에게영향을미친다. 만성폐쇄성폐질환 (COPD) 는또한이병률과사망률의주요원인이기도하다. 2030 년만성폐쇄성폐질환 (COPD) 는세계사망원인 3 위가될전망이다.[4]

환자들이경험하는악화의수를줄이는것은여전히충족되지않은주요만성폐쇄성폐질환 (COPD) 수요이다. 통계에따르면, 환자들이보고하지않는악화가최대 50% 에달한다고한다.[5] 만성폐쇄성폐질환 (COPD) 악화는환자의건강상태를결정하는가장중요한인자이자, 치료와예방관점에서중요한치료목표이다. 편집자주 : 만성폐쇄성폐질환 (COPD) 소개 요청시새로운전문가보고서와만성폐쇄성폐질환 (COPD) 배경설명을제공한다. 만성폐쇄성폐질환 (COPD) 에관한새로운전문가보고서저자들소개 만성폐쇄성폐질환 (COPD) 에관한전문가보고서에는호흡기관리부문주요이해관계자들이참여했다. - Dr Ondrej Rybnicek, 유럽알러지및기도질환환자연맹 (European Federation of Allergy and Airways Diseases Patients' Association, EFA) - Dr Stephen Rennard, Larson 의학교수, 네브라스카주오마하, 네브라스카대학병원내과 - Prof Andrew McIvor, 의학교수, 캐나다맥마스터대학 - Dr Alan Kaplan, Chairperson, College of Family Physicians of Canada 의호흡기의학특별관심포커스그룹의장 - Prof WisiaWedzicha, 호흡기교수, 런던대학호흡기센터 - Prof Robert Horne, UCL School of Pharmacy 행동의학교수, 실행과정책부부장및행동의학센터소장 - 유럽알러지및기도질환환자연맹 (European Federation of Allergy and Airways Diseases Patients' Association, EFA) 은알러지, 천식및만성폐쇄성폐질환 (COPD) 환자단체들로구성된유럽네트워크로서정보, 교육, 동료연락및재정지원을제공함으로써환자이익을도모한다. http://www.efanet.org/ Roflumilast 소개 Roflumilast 는새로운작용방식을바탕으로만성폐쇄성폐질환 (COPD) 염증을공략하도록개발된최초의항염증제다. Roflumilast 의활성성분 roflumilast 는강력한 PDE4 효소선택억제제다.[6] 네건의대규모무작위위약대조실험을실시한결과, roflumilast 는장기작용을하는기관지확장제와함께처방할경우악화를유의하게줄이고, 폐기능을개선하는것으로나타났다.[7,8,9] EU 에서 Roflumilast 는악화가자주발생하는성인환자의만성기관지염과관련된중증만성폐쇄성폐질환 (COPD)(FEV1 기관지확장제처방후 50% 이하예측 ) 를치료하기위해서기관지확장제와더불어처방된다.[10] 임상실험에는 1 만 2 천명이넘는환자들이참가했다. Roflumilast 는전반적으로내성이좋았다. 환자들이보고한가장흔한부작용은설사 (5.9%), 체중감소 (3.4%), 오심 (2.9%), 복통 (1.9%) 및두통 (1.7%) 이었다. 이들부작용은대부분경증이거나중등도수준을보였다. 이들부작용은주로치료초기에발생했으며, 대부분치료가지속되면서해소됐다.[10] Takeda Pharmaceuticals International GmbH 소개 취리히에본사가위치한 Takeda Pharmaceuticals International GmbH 는일본오사카에위치한 Takeda Pharmaceutical Company Limited 의완전소유자회사다. 연구기반국제기업인 Takeda 는의약품에중점을둔다. 일본최대의제약회사이자세계최고의제약회사중

하나인 Takeda 는주도적인의학혁신을통해전세계환자들의건강을증진시키는데전념한다. Takeda 에관한추가정보는회사웹사이트 http://www.takeda.com 을참조한다. 참조문헌 1. 만성폐쇄성폐질환 (COPD) 진단, 관리및예방을위한국제전략, 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. 만성폐쇄성폐질환 (COPD) 을위한지속형베타 2- 수용체작용제가들어간 Roflumilast: 악화병력의영향, EurRespir J 2011;38:553-560. 3. Fabbri LM, et al. 고증후성만성폐쇄성폐질환 (COPD) 환자에서 roflumilast 의효과 [ 초록 ]. 제 22 회유럽호흡기학회연례회의 : 2012 년 9 월 1-5 일 ; 오스트리아빈 : ERS; 2012. 초록 P742. 4. 세계보건기구 (WHO). 만성폐쇄성폐질환 (COPD). 팩트시트 No 315. 2008. http://www.who.int/mediacentre/factsheets/fs315/en/index.html (2012 년 6 월접속 ) 5. Seemungal TAR, Donaldson GC, Paul EA,Bestall JC, Jeffries DJ, Wedzicha JA. 만성폐쇄성폐질환환자에서악화가삶의질에미치는영향. Am J RespirCrit Care Med 1998;157:1418-1422 6. Hatzelmann A, et al. 만성폐쇄성폐질환진행에서선택적구강 phosphodiesterase 4 억제제 roflumilast 의임상전약리학, Pulm Pharm Ther 2010;23:235-256. 7. Calverley PMA, et al. 증후성만성폐쇄성폐질환에서 Roflumilast: 두건의무작위임상실험. Lancet 2009; 374: 685-94. 8. Fabbri LM, et al. 지속형기관지확장제로치료하는중등도 - 중증만성폐쇄성폐질환에서 Roflumilast: 두건의무작위임상실험. Lancet 2009;374:695-703. 9. Rabe KF. 만성폐쇄성폐질환치료를위한 phosphodiesterase 4 억제제 roflumilast 의업데이트. Br J Pharm 2011;163:53-67. 10. EU 제품특성요약, Daxas(R), 2011 년 5 월 (http://www.ema.europa.eu) 본배포자료는 Takeda Pharmaceuticals International GmbH, Thurgauerstrasse 130, CH-8152 Glattpark-Opfikon (Zurich), Switzerland 에의해배포됐다. 출처 : Takeda Pharmaceuticals International GmbH 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, August 28, 2012/PRNewswire/ -- 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. To view the Multimedia News Release, please click: http://www.multivu.com/mnr/56582-expert-report-on-copd-launch 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. 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, University College London - Prof Robert Horne, Professor of Behavioural Medicine, UCL School 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 COPDspecific 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 addon 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. References 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(R), May 2011 (available at http://www.ema.europa.eu) This press release has been issued by Takeda Pharmaceuticals International GmbH, Thurgauerstrasse 130, CH-8152 Glattpark-Opfikon (Zurich), Switzerland Source: Takeda Pharmaceuticals International GmbH