CHERTSEY, England, November 26, 2014 /PRNewswire/ --
Recurrence has been identified by The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) as the most important problem in the treatment of CDI.
New analysis from a unique real-world study demonstrates that first-line use of fidaxomicin[▼], is clinically effective in reducing recurrence rates and lowering mortality, and provides cost savings for the treatment of potentially fatal Clostridium difficile infection (CDI).
Initial analysis, pooled from five trial centres across the UK who introduced fidaxomicin between July and December 2012, were presented today at the Federation of Infection Societies (FIS) Conference. The real-world analysis supports clinical trial data in highlighting dramatically reduced recurrence rates (74% relative reduction) in those treated first-line with fidaxomicin, compared with standard of care treatments; vancomycin and metronidazole.
Commenting on the findings, Dr Simon Goldenberg, Consultant Microbiologist and Infection Control Doctor, Guy's and St Thomas' NHS Foundation Trust, said: "The analysis of these service evaluations highlight the potential improved outcomes that could be achieved with this new approach to CDI management. In the last ten years we have drastically reduced rates of CDI in the UK through stringent hospital hygiene protocols and infection prevention measures, yet recurrence remains an issue. This analysis supports a growing consensus that fidaxomicin should be used first line in all patients diagnosed with CDI to address recurrence, improve patient outcomes and ultimately save valuable NHS resources."
Data collected from a total of 107 patients treated first-line with fidaxomicin during the 12 month evaluation period were compared with those from a retrospective cohort treated with standard of care (vancomycin or metronidazole) during the previous 12 month period. In the group treated with fidaxomicin first line, in addition to the significant reduction in relative recurrence, there was also a lower 28-day all-cause mortality compared to older treatments (7.6% vs. 23.3% respectively).
Based on an in-depth costing analysis at a single evaluation centre, treating a patient for a second episode of CDI cost £20,249. For every 50 initial infections treated with fidaxomicin, six recurrences were avoided compared to treatment with older therapies. Taking into account total treatment cost, the data demonstrates a case for the cost-effectiveness of first line treatment with fidaxomicin, resulting in a cost saving of £40,841 to the NHS for every 50 patients treated. With 13,361 cases of CDI reported in the UK between April 2013 and March 2014, the potential cost saving is likely to be far greater. As such, fidaxomicin has the potential to significantly free up vital NHS resources by preventing extended hospital stays caused by recurrence.
Only 2.8% of patients treated with fidaxomicin had a recurrence of CDI, compared with a 10.6% recurrence rate with vancomycin/metronidazole in the preceding year. Recurrence is a major challenge in CDI treatment, with previous studies reporting that patients who have already had one recurrence, have a 40% risk of a further episode of CDI. Importantly, in this real-world study, there were no second recurrences reported in those treated with fidaxomicin compared with 23.8% in those treated with standard of care therapies. Hence, the observed reduction in recurrence rates and reduced hospital stays since the introduction of fidaxomicin as first-line treatment for CDI has culminated in overall cost savings.
"CDI is a potentially deadly bacterial infection that not only causes significant distress for vulnerable patients but also has serious cost implications for health systems," comments Professor Oliver Cornely, University Hospital Cologne, Germany. "In these analyses we see that fidaxomicin provides a dual benefit of reducing the burden of recurrence, a major treatment challenge, but also provides a cost effective alternative to the current standard of care. This real life data demonstrates a treatment advance that can improve patient outcomes and reduce the significant burden of this disease, which will hopefully lead to improved management of CDI in clinical practice."
In Europe the incidence and severity of CDI is increasing, posing a major threat to healthcare systems and patients.,,, Information suggests approximately 300,000 cases of CDI occur in Europe each year, and that CDI results in death for 9% (2% primary cause, 7% contributory) of all diagnosed patients. This suggests that CDI contributes to the death of around 27,000 people each year, or 2,250 each month across Europe, around five times that of MRSA associated deaths.
Based on the results observed in this study, the first and only real-world evaluation of available antibiotics for CDI in the UK, first-line use of fidaxomicin could improve clinical outcomes in the treatment and management of CDI and its associated recurrences, resulting in an overall cost saving.
NOTES TO EDITORS
About the real-world Study
The real world study assessed the available antibiotics for CDI patients in the UK and results were presented on 26th November 2014 at the Federation of Infection Societies (FIS) conference 2014.
The evaluation looked specifically at the clinical-effectiveness and cost-effectiveness of fidaxomicin in clinical practice versus older therapies; vancomycin and metronidazole.
Five trial centres from across the UK participated in the evaluation and patient data was pooled from each centre to generate final results. Centres involved are as follows:
- Leeds Teaching Hospitals NHS Trust
- Guy's and St Thomas' NHS Foundation Trust
- County Durham & Darlington NHS Foundation Trust
- University Hospitals of Morecambe Bay - NHS Foundation Trust
- St George's Healthcare NHS Trust
These results represent the interim findings of a larger cohort of real world data being collected and analysed from across seven UK secondary care trusts, to assess the effectiveness of fidaxomicin. Data reporting from additional study centres are expected to be published next year.
About Clostridium difficile Infection
CDI is a serious illness resulting from infection of the internal lining of the colon by C. difficile bacteria. The bacteria produce toxins that cause inflammation of the colon, diarrhoea and, in some cases, death. Patients typically develop CDI after the use of broad-spectrum antibiotics that disrupt normal bowel flora, allowing C. difficile bacteria to flourish. CDI is the leading cause of hospital acquired (nosocomial) diarrhoea in industrialised countries and the risk of CDI and disease recurrence is particularly high in patients aged 65 years and older. Recurrence of CDI occurs in up to 25% of patients within 30 days of initial treatment with current therapies.,, The ESCMID has identified recurrence as being the most important problem in the treatment of CDI.
About Astellas Pharma EMEA
Astellas Pharma EMEA operates in 40 countries across Europe, the Middle East and Africa, and is the EMEA regional business 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's focus is to deliver outstanding R&D and marketing to continue growing in the world pharmaceutical market. Astellas presence in Europe also includes an R&D site and three manufacturing plants. The company employs over 4,500 people across the EMEA region. In 2013 Astellas was awarded SCRIP Pharmaceutical Company of the Year in recognition of its commercial success and pipeline development.
About DIFICLIR (fidaxomicin)
DIFICLIR is a first-in-class macrocyclic antibiotic, which contains the active substance fidaxomicin. It is indicated for the treatment of Clostridium difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD). It is the first licensed antibiotic treatment for CDI since the 1950s. Fidaxomicin is a targeted narrow spectrum antibiotic with highly selective activity against C. difficile bacteria rather than other gut flora.
- 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.
- Nayar D, et al. Real world evaluation of the introduction of fidaxomicin on the management of Clostridium difficile infection (CDI) in NHS secondary care trusts in England. Oral presentation presented at FIS 2014.
- Annual Epidemiological Commentary: Mandatory MRSA, MSSA and E. coli bacteraemia and C. difficile infection data. Available at; https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/330529/HCAI_mandatory_surveillance_annual_epidemiological_commentary_2013_14.pdf [Last accessed November 2014].
- Kelly CP, LaMont JT. Clostridium difficile - more difficult than ever. N Engl J Med. 2008;359(18):1932−1940.
- Lyytikäinen O, et al. Hospitalizations and Deaths Associated with Clostridium difficile Infection, Finland, 1996-2004. Emerg Infect Dis. 2009;15:761-5.
- Soler P, et al. Rates of Clostridium difficile infection in patients discharged from Spanish hospitals, 1997-2005. Infect Control Hosp Epidemiol. 2008;29:887-9.
- Vonberg RP, et al. Clostridium difficile in Discharged Inpatients, Germany. Emerg Infect Dis. 2007;13:179-80.
- Freeman J, et al. The Changing Epidemiology of Clostridium difficile Infections. Clin Microbiol Rev. 2010;23(3):529-549.
- Kuijper EJ et al. ESCMID study group for Clostridium difficile. Emergence of Clostridium difficile associated disease in North America and Europe. Clin Microbiol Infect. 2006;12:2-18.
- Bauer MP, Notermans DW, van Benthem BH, et al. Clostridium difficile infection in Europe: a hospital-based survey. Lancet. 2011;377:63-73.
- Kock, R. et al. Methicillin-resistant Staphylococcus aureus (MRSA): burden of disease and control challenges in Europe. Eurosurveillance. 2010; Volume 15, Issue 41.
- Poutanen SM, et al. Clostridium difficile-associated diarrhoea in adults. CMAJ. 2004;171:51-8.
- Crobach MJ, et al. European Society of Clinical Microbiology and Infectious Diseases (ESCMID): Data review and recommendations for diagnosing Clostridium difficile-infection (CDI). Clin Micro Infect. 2009;15:1053-1066.
- Pepin J, et al. Increasing risk of relapse after treatment of Clostridium difficile colitis in Quebec, Canada. Clin Infect Dis. 2005;40:1591-7.
- Lowy I, et al. Treatment with Monoclonal Antibodies against Clostridium difficile Toxins. N Engl J Med. 2010;362;3:197-205.
- 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.
- Louie TJ, et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med. 2011;364:422-31.
- Mullane K. Gorbach S. Fidaxomicin: first-in-class macrocyclic antibiotic. Expert Rev 2011. Anti Infec Ther 9(7):767-77.
- Dificlir summary of product characteristics http://www.ema.europa.eu/docs/en_GB/document_library/EPAR-Product_Information/human/002087/WC500119705.pdf [Last accessed November 2014].
- Levine DP. Vancomycin: a history. Clinical Infectious Diseases. 2006;42:S5-12.
Date of preparation: November 2014
SOURCE Astellas Pharma EMEA