title: Intravenous micafungin versus voriconazole for chronic pulmonary aspergillosis: a multicenter trial in Japan.
abstract: Chronic pulmonary aspergillosis (CPA) is slowly progressive inflammatory pulmonary syndrome due to Aspergillus spp. The evidence regarding CPA treatment is limited. We conducted a randomized, multicenter, open-label trial comparing intravenous micafungin (MCFG) of 150-300 mg once daily with intravenous voriconazole (VRCZ) of 6 mg/kg twice on Day 1 followed by 4 mg/kg twice daily for the treatment of 107 in patients with CPA to compare the efficacy and safety of both drugs as initial treatment in Japan. Treatment effectiveness was defined by clinical, mycological, radiological and serological responses 2 weeks after the initial administration and at the end of therapy. The total of 50 and 47 patients were assigned to the MCFG and VRCZ groups, respectively. The difference in efficacy rates between MCFG and VRCZ was not significant, either after 2 weeks [68.0% vs. 58.7%; the absolute difference, 9.3% with a 95% confidence interval (CI), -9.97 to 28.58, P = 0.344] or at the end of therapy (60.0% vs. 53.2%; the absolute difference, 6.8% with a 95% CI, -12.92 to 26.54, P = 0.499). In the safety evaluation, fewer adverse events occurred in the MCFG than VRCZ group (26.4% vs. 61.1%, P = 0.0004). MCFG was as effective as VRCZ and significantly safer than as an initial treatment of CPA. (UMIN Clinical Trials Registry number, UMIN000001786.).
authors.affiliation: Department of Molecular Microbiology and Immunology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki 852-8501, Japan. s-kohno@nagasaki-u.ac.jp
authors.forename: Shigeru
authors.initials: S
authors.lastname: Kohno
authors.forename: Koichi
authors.initials: K
authors.lastname: Izumikawa
authors.forename: Kenji
authors.initials: K
authors.lastname: Ogawa
authors.forename: Atsuyuki
authors.initials: A
authors.lastname: Kurashima
authors.forename: Niro
authors.initials: N
authors.lastname: Okimoto
authors.forename: Ryoichi
authors.initials: R
authors.lastname: Amitani
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kakeya
authors.forename: Yoshihito
authors.initials: Y
authors.lastname: Niki
authors.forename: Yoshitsugu
authors.initials: Y
authors.lastname: Miyazaki
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000935:Antifungal Agents / Q000494:pharmacology* / Q000592:standards*; D001230:Aspergillus / Q000187:drug effects; D002908:Chronic Disease; D054714:Echinocandins / Q000494:pharmacology* / Q000592:standards*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007564:Japan; D055666:Lipopeptides / Q000494:pharmacology* / Q000592:standards*; D008297:Male; D000077551:Micafungin; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D055732:Pulmonary Aspergillosis / Q000000981:diagnostic imaging / Q000188:drug therapy*; D011743:Pyrimidines / Q000008:administration & dosage; D011859:Radiography; D016896:Treatment Outcome; D014230:Triazoles / Q000008:administration & dosage; D065819:Voriconazole
chemical_list: D000935:Antifungal Agents; D054714:Echinocandins; D055666:Lipopeptides; D011743:Pyrimidines; D014230:Triazoles; D065819:Voriconazole; D000077551:Micafungin