Volume 12 Supplement 2

28th International Symposium on Intensive Care and Emergency Medicine

Open Access

Pooled analysis of safety for micafungin

  • OA Cornely1,
  • P Maddison2 and
  • AJ Ullmann3
Critical Care200812(Suppl 2):P21

https://doi.org/10.1186/cc6242

Published: 13 March 2008

Introduction

Micafungin (MICA) is an efficacious antifungal treatment for life-threatening fungal infections [14].

Methods

We characterised the safety of MICA by analysing pooled adverse event (AE) data from 17 clinical studies conducted worldwide. All patients (n = 3,028) received ≥ 1 dose of intravenous MICA; a median daily dose of 100 mg for adults and 1.5 mg/kg for children over a mean duration of 18 and 29 days, respectively.

Results

Median age was 40.5 (range <0.1–92) years, including 296 (9.8%) children (<16 years old) and 387 (12.8%) elderly patients (≥ 65 years old). Common underlying conditions were haematopoietic stem cell or other transplantation (26%), malignancies (21%) and HIV (33%). The most frequently reported MICA-related AEs were nausea (2.8%), vomiting (2.5%), phlebitis (2.5%), hypokalaemia (2.1%), pyrexia (2.1%), diarrhoea (2.0%), and increases in alkaline phosphatase (2.7%), aspartate aminotransferase (2.3%) and alanine aminotransferase (2.0%). In comparative studies, the MICA safety profile was superior to liposomal amphotericin B, and similar to fluconazole and caspofungin (Figure 1).
Figure 1

Treatment-related adverse events (incidence > 5%) from comparative studies. Number (%) of patients.

Conclusion

This large database with more than 3,000 patients demonstrated a favourable clinical safety profile for micafungin.

Authors’ Affiliations

(1)
Universität Klinikum Köln
(2)
Astellas Pharma Europe BV
(3)
Klinikum derJohannes Gutenberg-Universität

References

  1. Kuse ER, et al: Lancet. 2007, 369: 1519-1527. 10.1016/S0140-6736(07)60605-9.PubMedView ArticleGoogle Scholar
  2. de Wet NT, et al: Aliment Pharmacol Ther. 2005, 21: 899-907. 10.1111/j.1365-2036.2005.02427.x.PubMedView ArticleGoogle Scholar
  3. van Burik JA, et al: Clin Infect Dis. 2004, 39: 1407-1416. 10.1086/422312.PubMedView ArticleGoogle Scholar
  4. Pappas PG, et al: Clin Infect Dis. 2007, 45: 883-893. 10.1086/520980.PubMedView ArticleGoogle Scholar

Copyright

© BioMed Central Ltd 2008

This article is published under license to BioMed Central Ltd.

Advertisement