Accumulated safety data of micafungin in therapy and prophylaxis in fungal diseases.

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.

• Authors: Oliver A Cornely, Peter G Pappas, Jo-Anne H Young, Philip Maddison, Andrew J Ullmann
• Journal: Expert opinion on drug safety (Expert Opin Drug Saf) Vol. 10 Issue 2 Pg. 171-83 (Mar 2011) ISSN: 1744-764X [Electronic] England
• PMID: 21306282 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antifungal Agents
• Echinocandins
• Lipopeptides
• Micafungin

Topics

• Adolescent
• Adult
• Age Factors
• Aged
• Aged, 80 and over
• Antifungal Agents (administration & dosage, adverse effects, therapeutic use)
• Child
• Child, Preschool
• Clinical Trials as Topic
• Databases, Factual
• Dose-Response Relationship, Drug
• Echinocandins (administration & dosage, adverse effects, therapeutic use)
• Female
• Humans
• Infant
• Lipopeptides (administration & dosage, adverse effects, therapeutic use)
• Male
• Micafungin
• Middle Aged
• Mycoses (drug therapy, prevention & control)
• Time Factors
• Young Adult