![Sample our Medicine, Dentistry, Nursing & Allied Health journals, sign in here to start your FREE access for 14 days]({"type":"image" , "src" : "/sda/5944/TOC-Subject-Sample-2021-Medicine-Dentistry-Nursing-Allied-Health.jpg"})
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.
Keywords::
Acknowledgements
This manuscript was prepared by the authors with medical writing and editorial support from M Jenvey, a medical writer at Envision Pharma. OA Cornely proposed key elements of the analysis concept and design, was involved in acquisition of data, analysis and interpretation of data, drafting of the manuscript, and critical revision of the manuscript for intellectual content. PG Pappas proposed key elements of the analysis concept and design, was involved in analysis and interpretation of data, and critical revision of the manuscript for intellectual content. JAH Young proposed key elements of the analysis concept and design, was involved in acquisition of data, analysis and interpretation of data, drafting of the manuscript, and critical revision of the manuscript for intellectual content. P Maddison was involved in acquisition of data and confirmed the alignment with the global safety database, was involved in analysis and interpretation of data, drafting of the manuscript, and critical revision of the manuscript for intellectual content. AJ Ullmann proposed key elements of the analysis concept and design, was involved in acquisition of data, analysis, drafting of the manuscript, and critical revision of the manuscript for intellectual content. All authors read and approved the final manuscript.