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.
Bibliographical noteFunding Information:
These studies were supported by Astellas Pharma GmbH, Munich. Editorial support was provided by Envision Pharma, whose assistance was funded by Astellas. OA Cornely is supported by the German Federal Ministry of Research and Education (BMBF grant 01KN0706); has received research grants from Actelion, Astellas, Basilea, Bayer, Biocryst, Celgene, F2G, Genzyme, Gilead, Merck/ Schering, Miltenyi, Optimer, Pfizer, Quintiles, and Viro-pharma; is a consultant to Astellas, Basilea, F2G, Gilead, Merck/Schering, M€olnlycke, Optimer, and Pfizer; has served on speakers’ bureaus for Astellas Pharma, Gilead, Merck/ MSD, Pfizer, Essex/Schering-Plough, SpePharm and United Medical; and received lecture honoraria from Astellas, Gilead, Merck/Schering, and Pfizer. PG Pappas has received research grants from Merck, Pfizer and Astellas Pharma; and has been an ad hoc advisor for Merck, Pfizer, Astellas Pharma, Novartis, Basilea and Eisai. J-AH Young receives payment for clinical trials conducted for Astellas Pharma, Pfizer, Merck, Schering-Plough, ViroPharma, GlaxoSmith-Kline and Advanced Biologics; she is not a consultant and does not serve on a speaker’s bureau. AJ Ullmann has served as a consultant for Astellas Pharma, Basilea, Gilead, MSD, Pfizer and Schering-Plough and has participated in speakers’ bureaus for Astellas Pharma, Gilead, MSD, Pfizer and Schering-Plough. P Maddison is an employee of Astellas Pharma Europe B.V., Leiderdorp, The Netherlands.