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.
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: Daniel K Benjamin; Jaime G Deville; Nkechi Azie; Laura Kovanda; Mike Roy; Chunzhang Wu; Antonio Arrieta Journal: Pediatr Infect Dis J Date: 2013-11 Impact factor: 2.129
Authors: C López-Sánchez; D Valcárcel; V Gómez; J López-Jiménez; D Serrano; V Rubio; C Solano; L Vázquez; I Ruiz Journal: Rev Esp Quimioter Date: 2020-02-14 Impact factor: 1.553
Authors: Laura L Kovanda; Thomas J Walsh; Daniel K Benjamin; Antonio Arrieta; David A Kaufman; P Brian Smith; Paolo Manzoni; Amit V Desai; Atsunori Kaibara; Peter L Bonate; William W Hope Journal: Pediatr Infect Dis J Date: 2018-06 Impact factor: 2.129