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DIFICLIR proven to be both clinically and cost-effective compared to standard of care in real-world patients with Clostridium difficile infection

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).2 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.1

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.2

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.2 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).2

Based on an in-depth costing analysis at a single evaluation centre, treating a patient for a second episode of CDI cost £20,249.2 For every 50 initial infections treated with fidaxomicin, six recurrences were avoided compared to treatment with older therapies.2 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.2 With 13,361 cases of CDI reported in the UK between April 2013 and March 2014,3 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.2 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.4 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.2

“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.5,6,7,8 Information suggests approximately 300,000 cases of CDI occur in Europe each year,9 and that CDI results in death for 9% (2% primary cause, 7% contributory) of all diagnosed patients.10 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.11

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.

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.

Source

1. 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.

2. 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.

3. 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].

4. Kelly CP, LaMont JT. Clostridium difficile – more difficult than ever. N Engl J Med. 2008;359(18):1932?1940.

5. Lyytikäinen O, et al. Hospitalizations and Deaths Associated with Clostridium difficile Infection, Finland, 1996-2004. Emerg Infect Dis. 2009;15:761-5.

6. 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.

7. Vonberg RP, et al. Clostridium difficile in Discharged Inpatients, Germany. Emerg Infect Dis. 2007;13:179-80.

8. Freeman J, et al. The Changing Epidemiology of Clostridium difficile Infections. Clin Microbiol Rev. 2010;23(3):529-549.

9. 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.

10. Bauer MP, Notermans DW, van Benthem BH, et al. Clostridium difficile infection in Europe: a hospital-based survey. Lancet. 2011;377:63-73.

11. Kock, R. et al. Methicillin-resistant Staphylococcus aureus (MRSA): burden of disease and control challenges in Europe. Eurosurveillance. 2010; Volume 15, Issue 41.

Source: Astellas Pharma EMEA