Vol.58 No.2 March 2010
Clinical efficacy and safety of micafungin, a novel echinocandin antifungal drug, in pulmonary aspergillosis in a postmarketing setting
1)Department of Molecular Microbiology and Immunology, Nagasaki University Graduate School of Medical Science, 1-7-1 Sakamoto, Nagasaki, Japan
2)Department of Clinical Infectious Diseases, School of Medicine, Showa University
3)Department of Respiratory Medicine, Osaka Red Cross Hospital
4)Department of Clinical Research, National Hospital Organization, Higashi Nagoya National Hospital
5)Department of Respiratory Medicine, Fukujuji Hospital
6)Department of Bioactive Molecules, National Institute of Infectious Diseases
Abstract
Clinical efficacy and safety of micafungin(MCFG) in chronic pulmonary aspergillosis(CPA) were evaluated based on postmarketing survey data on 109 subjects from 35 medical institutions.
Of these, 18 not diagnosed with CPA or violating specifications on concomitant drugs were excluded from clinical efficacy evaluation. Apart from 11 nonevaluable subjects, the overall efficacy in 80 was 63.8% (51/80). Overall efficacy by diagnosis was 62.0% (31/50) with chronic necrotizing pulmonary aspergillosis(CNPA) and 66.7% (20/30) with aspergilloma. Overall efficacy was 57.1% (24/42) in the MCFG monotherapy group and 71.1% (27/38) in the antifungal combination therapy group. No apparent differences were seen in overall efficacy by dose among those mildly ill, i.e., 69.8% (30/43) for doses of ≤150 mg vs. 68.4% (13/19) for doses of >150 mg. Observed overall efficacy for doses of ≤150 mg was moderately lower than that for doses of >150 mg among those who were very ill, i.e., 28.6% (2/7) vs. 54.5% (6/11).
Total of 35 adverse drug reactions(ADRs) were observed in 22 of 61 subjects (36.1%) in the MCFG monotherapy group. The most common ADR was abnormal hepatic function, although none of the cases were serious or considered to have a definite causal relationship to MCFG. Of the 35 adverse drug reactions, only 1 case of renal impairment was serious and considered to have a definite causal relationship to MCFG. Aging and higher dosage did not affect ADR incidence.
These results indicate that MCFG has favorable efficacy and safety profiles in the treatment of CPA in a postmarketing setting.
Key word
micafungin, efficacy, safety, necrotizing pulmonary aspergillosis
Received
August 11, 2009
Accepted
January 29, 2010
Jpn. J. Chemother. 58 (2): 128-139, 2010
