Intravenous micafungin versus voriconazole for chronic pulmonary aspergillosis: A multicenter trial in Japan

• Published in: The Journal of infection Vol. 61; no. 5; pp. 410 - 418
• Main Authors: Kohno, Shigeru, Izumikawa, Koichi, Ogawa, Kenji, Kurashima, Atsuyuki, Okimoto, Niro, Amitani, Ryoichi, Kakeya, Hiroshi, Niki, Yoshihito, Miyazaki, Yoshitsugu
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier Ltd 01.11.2010; Elsevier
• Subjects: Aged; Aged, 80 and over; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antifungal agents; Antifungal Agents - pharmacology; Antifungal Agents - standards; Aspergillus; Aspergillus - drug effects; Biological and medical sciences; Chronic Disease; Chronic pulmonary aspergillosis; Echinocandins - pharmacology; Echinocandins - standards; Female; General aspects; Human mycoses; Humans; Infectious Disease; Infectious diseases; Infusions, Intravenous; Japan; Lipopeptides - pharmacology; Lipopeptides - standards; Male; Medical sciences; Micafungin; Microbial Sensitivity Tests; Middle Aged; Mycoses; Mycoses of the respiratory system; Pharmacology. Drug treatments; Pulmonary Aspergillosis - diagnostic imaging; Pulmonary Aspergillosis - drug therapy; Pyrimidines - administration & dosage; Radiography; Treatment Outcome; Triazoles - administration & dosage; Voriconazole; Asia; Japan; Micafungin; Chronic pulmonary aspergillosis; Voriconazole; Lung disease; Intravenous administration; Mycosis; Enzyme; Respiratory disease; Azole derivatives; Transferases; Glycosyltransferases; Enzyme inhibitor; 1,3-β-Glucan synthase; Echinocandine derivatives; Infection; Antifungal agent; Chronic; Pulmonary aspergillosis; Triazole derivatives; Hexosyltransferases; Comparative study
• ISSN: 0163-4453; 1532-2742
• DOI: 10.1016/j.jinf.2010.08.005

Summary 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.)