Pooled analysis of safety for micafungin

Introduction

Micafungin (MICA) is an efficacious antifungal treatment for life-threatening fungal infections [1–4].

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.