IAccumulated safety data of micafungin in therapy and prophylaxis in fungal diseases

Academic Article

Abstract

  • Objective: To define better the safety profile of micafungin, an analysis of micafungin clinical trial safety data was undertaken. Research design and methods: Adverse event data were pooled worldwide from 17 clinical efficacy and safety studies. Adverse events were coded using the Medical Dictionary for Regulatory Activities version 5.0. Results: In the pooled clinical trial data set, 3028 patients received at least one dose of micafungin. The mean age of patients was 41.4 years; with 296 (9.8%) children (< 16 years) and 387 (12.8%) elderly patients (≥ 65 years). Common underlying conditions were hematopoietic stem cell and other transplantations (26.1%), malignancies (20.8%) and HIV (32.9%). Mean exposure was 18 days for adults and 29 days for children. The most frequently reported treatment-related adverse events were nausea (2.8%), vomiting (2.5%), phlebitis (2.5%), hypokalemia (2.1%), fever/pyrexia (2.1%) and diarrhea (2%), as well as increases in alkaline phosphatase (2.7%), aspartate aminotransferase (2.3%) and alanine aminotransferase (2%). Although elderly adults had a higher incidence of renal impairment (1%) compared with non-elderly adult (0.1%) and pediatric patients (0.3%), there were no clear trends showing an association between higher doses of micafungin or longer treatment durations and increased incidence rates of treatment-related adverse events. Conclusions: Analysis of a large database demonstrated a favorable clinical safety profile for micafungin similar to other echinocandins. © 2011 Informa UK, Ltd.
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    Digital Object Identifier (doi)

    Author List

  • Cornely OA; Pappas PG; Young JAH; Maddison P; Ullmann AJ
  • Start Page

  • 171
  • End Page

  • 183
  • Volume

  • 10
  • Issue

  • 2