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New Expert Report Informs Europe's Policymakers on Crucial Changes Needed to Improve the Diagnosis and Management of CDI

 New Expert Report Informs Europe's Policymakers on Crucial Changes Needed to
                 Improve the Diagnosis and Management of CDI

  PR Newswire

  CHERTSEY, England, April 19, 2013

CHERTSEY, England, April 19, 2013 /PRNewswire/ --

 Clostridium  difficile infection (CDI), a potentially fatal disease, is one
of the  most common healthcare-associated infections ^[1]

Urgent action is needed to improve the diagnosis and management of CDI, which
is the main cause of hospital-acquired (nosocomial) diarrhoea in
industrialised countries. ^[2] In a report launched today, during a meeting
hosted by the European Healthcare and Hospital Federation (HOPE), experts from
across Europe highlight the current deficiencies in the management of CDI and
outline the steps that are needed to address them.

To view the Multimedia News Release, please click:

http://www.multivu.com/mnr/60637-astellas-report-diagnosis-management-CDI

Hospital patients with CDI are up to three times more likely to die in
hospital (or within a month of infection) than those without CDI. ^[3],[4]
Furthermore, CDI has an enormous impact on healthcare systems and infected
patients can stay in hospital an extra 1-3 weeks ^[5],[6],[7] at an additional
cost of up to €14,000, compared with patients without CDI. ^[8] The reported
levels of CDI across Europe vary widely. ^[9],[10],[11],[12],[13] However,
failure to detect CDI cases leads to confusion about the true incidence of
this HAI. A recent comprehensive incidence study was carried out in Spain, in
2010, and found that two thirds of CDI cases were undiagnosed or misdiagnosed.
^[14]

The CDI in Europe Report , written by a group of leading European infectious
disease experts with the support of Astellas Pharma Europe Ltd., demonstrates
how CDI threatens patient safety and the quality of care provided. The Report
makes recommendations to improve CDI management, within the context of current
EU policy initiatives, which call for increased awareness of the signs and
symptoms of CDI to improve rates of testing and diagnosis as well as improved
awareness of and compliance with guidelines for CDI therapy and infection
control. The Report also makes a case for the introduction of national-level
surveillance systems in all Member States and increased patient education and
awareness.

"It's vital that governments see CDI management as a key indicator of patient
safety and quality of care, and ensure that robust systems are in place to
address it," comments Professor Mark Wilcox, Professor of Medical Microbiology
at the University of Leeds and one of the CDI in Europe Report authors. "CDI
is a problem in hospitals and nursing homes and can be a major drain on
healthcare resources. I believe implementation of the recommendations made in
this Report will help improve the recognition of CDI and subsequently lead to
a reduction in its incidence and impact on patients' lives."

The Report identifies a number of reasons why CDI is not being well managed.
In many countries there is an inadequate level of awareness of CDI among
doctors and other healthcare workers, resulting in under-diagnosis. Where this
happens treatment is delayed or omitted, leading to increased morbidity and
complications in the treatment of co-existing diseases. Proactive infection
control measures may also be delayed, risking further outbreaks. Additionally,
only a third of European countries have a nationally recommended diagnostic
test algorithm for CDI, ^[15] with testing in nursing homes and the community
being particularly limited.   

"We welcome this Report and its recommendations to improve the management of
patients with CDI," says Pascal Garel, Chief Executive of the European
Hospital and Healthcare Federation (HOPE). "Healthcare-associated infections,
especially CDI - a prominent infection in Europe, are of paramount concern to
hospitals. We have solutions and good practices - the goal now is to increase
our efforts to promote them across Europe to address HAIs and reduce their
burden on European hospitals and patients."

A full copy of the Report and its recommendations are available from
http://www.epgonline.org/anti-infectives-knowledge-network/index.cfm .

NOTES FOR EDITORS

The authors of 'The CDI in Europe' Report are focused on driving change at a
policy level with the aim to translate research on CDI into meaningful policy
responses to help; raise awareness of CDI, improve and standardise
microbiological surveillance and testing, promote a better standard of care
for CDI management across Europe (including diagnostic testing, therapy, and
infection control and prevention) and ultimately to improve patient outcomes.

This effort is not intended to duplicate the important projects of the
European Centre for Disease Prevention and Control (ECDC), i.e. the
ECDC-funded European CDI Surveillance Network (ECDIS-Net) project, and the
European Society of Clinical Microbiology and Infectious Diseases (ESCMID),
but rather to supplement the work taking place in academic circles and further
the reach of the outputs from these and other important initiatives.

About  Clostridium difficile  Infection (CDI)

CDI is a serious illness resulting from infection of the internal lining of
the colon by C. diffici le bacteria. The bacteria produce toxins that cause
inflammation of the colon, diarrhoea and, in some cases, death. ^[16] Patients
typically develop CDI after the use of broad-spectrum antibiotics that disrupt
normal bowel flora, allowing C. difficile bacteria to flourish. ^[16],[17] The
risk of CDI and disease recurrence is particularly high in patients aged 65
years and older. ^[18] Recurrence of CDI occurs in up to 25% of patients
within 30 days of initial treatment with current therapies. ^[19],[20],[21]
The ESCMID has identified recurrence as being the most important problem in
the treatment of CDI. ^[22]

About HOPE

HOPE, the European Hospital and Healthcare Federation, is an international
non-profit organisation, created in 1966. HOPE represents national public and
private hospital associations and hospital owners, either federations of local
and regional authorities or national health services. Today, HOPE is made up
of 34 organisations coming from the 27 Member States of the European Union,
Switzerland and the Republic of Serbia. HOPE mission is to promote
improvements in the health of citizens throughout Europe, high standard of
hospital care and to foster efficiency with humanity in the organisation and
operation of hospital and healthcare services. For more information about
HOPE, please visit http://www.hope.be/ .

About Astellas Pharma Europe Ltd.

Astellas Pharma Europe Ltd., located in the UK, is the European headquarters
of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company
dedicated to improving the health of people around the world through the
provision of innovative and reliable pharmaceuticals. The organisation is
committed to becoming a global company by combining outstanding R&D and
marketing capabilities and continuing to grow in the world pharmaceutical
market. Astellas Pharma Europe Ltd. is responsible for 21 affiliate offices
located across Europe, the Middle East and Africa, an R&D site and three
manufacturing plants. The company employs approximately 4,300 staff across
these regions. For more information about Astellas Pharma Europe Ltd., please
visit http://www.astellas.eu/ .

References

[1] Ananthakrishnan AN. Clostridium difficile infection: epidemiology, risk
factors and management. Nat Rev Gastroenterol Hepatol. 2011;8:17-26.

[2] Crobach MJ, et al . European Society of Clinical Microbiology and
Infectious Diseases (ESCMID): Data review and recommendations for diagnosing
Clostridium difficile -infection (CDI). Clinical Microbiology and Infection
2009;15:1053-1066.

[3] Oake N, et al . The effect of hospital-acquired Clostridium difficile
infection on in-hospital mortality. Arch Intern Med 2010;170:1804-10.

[4] Hensgens MP, et al . All-Cause and disease-specific mortality in
hospitalized patients with Clostridium difficile infection: a Multicenter
Cohort Study. Clin Infect Dis 2013;56:1108-16.

[5] Vonberg RP, et al . Costs of nosocomial Clostridium difficile -associated
diarrhoea. J Hosp Infect. 2008;70:15-20.

[6] Wilcox MH, et al. Financial burden of hospital-acquired Clostridium
difficile infection. J Hosp Infect. 1996;34:23-30.

[7] Dubberke MD, Wertheimer AI. Review of current literature on the economic
burden of Clostridium difficile infection. Infect Control Hosp Epidemiol.
2009;30:57-66.

[8] Magalini S, et al . An economic evaluation of Clostridium difficile
infection management in an Italian hospital environment. Eur Rev Med Pharmacol
Sci 2012;16:2136-41.

[9] Bauer MP, et al . Clostridium difficile infection in Europe: a
hospital-based survey. Lancet . 2011;377:63-73.

[10] Lyytikäinen O, et al . Hospitalizations and Deaths Associated with
Clostridium difficile Infection, Finland, 1996-2004. Emerging Infectious
Diseases .2009;15:761-5.

[11] Søes L, et al . The emergence of Clostridium difficile PCR ribotype 027
in Denmark - a possible link with the increased consumption of
fluoroquinolones and cephalosporins? Euro  Surveillance . 2009;14:19176.

[12] Soler P, Nogareda F, Cano R. Rates of Clostridium difficile infection in
patients discharged from Spanish Hospitals, 1997-2005. Infection Control and
Hospital Epidemiology . 2008;29:887-9.

[13] Vonberg RP, Schwab F, Gastmeier P. Clostridium difficile in discharged
inpatients, Germany. Emerging Infectious Diseases . 2007;13:179-80.

[14] Alcala L, et al . The Undiagnosed cases of Clostridium difficile in a
whole nation: where is the problem? CMI 2012;18(7):E204-13.

[15] Notermans DW, et al . Enhancing laboratory capacity for Clostridium
difficile detection in Europe (Abstract P2286). Clin Micro Infect 2012;18
Suppl s3: 671.

[16] Poutanen SM, et al . Clostridium difficile -associated diarrhoea in
adults. CMAJ . 2004;171:51-8.

[17] Kelly CP, et al . Clostridium difficile infection. Ann Rev Med .
1998;49:375-390.

[18] Pepin J, et al . Increasing risk of relapse after treatment of
Clostridium difficile colitis in Quebec, Canada. Clin Infect Dis.
2005;40:1591-7.

[19] Bouza E, et al . Results of a phase III trial comparing tolevamer,
vancomycin and metronidazole in patients with Clostridium difficile
-associated diarrhoea. Clin Micro Infect. 2008;14(Suppl 7):S103-4.

[20] Lowy I, et al . Treatment with Monoclonal Antibodies against Clost ridium
difficile Toxins. N Engl J Med . 2010;362;3:197-205.

[21] Louie TJ, et al. Fidaxomicin versus vancomycin for Clostridium difficile
infection. N Engl J Med. 2011;364:422-31.

[22] Bauer MP, et al . European Society of Clinical Microbiology and
Infectious Disease (ESCMID): treatment guidance document for Clostridium
difficile- infection (CDI). Clin Microbiol Infect. 2009;15:1067-79.



Video:
http://www.multivu.com/mnr/60637-astellas-report-diagnosis-management-CDI

Contact: For further information please contact: Katy Compton-Bishop, Ruder
Finn, kcompton-bishop@ruderfinn.co.uk, Tel: +44(0)20-7438-3069; Mindy Dooa,
Astellas Pharma Europe Ltd. mindy.dooa@eu.astellas.com, Tel:
+44(0)1784-419-444