A double-blind comparative study of the safety and efficacy of caspofungin versus micafungin in the treatment of candidiasis and aspergillosis

• Published in: European journal of clinical microbiology & infectious diseases Vol. 32; no. 3; pp. 387 - 397
• Main Authors: Kohno, S., Izumikawa, K., Yoshida, M., Takesue, Y., Oka, S., Kamei, K., Miyazaki, Y., Yoshinari, T., Kartsonis, N. A., Niki, Y.
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer-Verlag 01-03-2013; Springer; Springer Nature B.V
• Subjects: Aged; Aged, 80 and over; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antifungal agents; Antifungal Agents - administration & dosage; Antifungal Agents - adverse effects; Aspergilloma; Aspergillosis; Aspergillosis - drug therapy; Aspergillus; Biological and medical sciences; Biomedical and Life Sciences; Biomedicine; Candida; Candidiasis; Candidiasis - drug therapy; Caspofungin; Comparative studies; Data processing; Double-Blind Method; Drug dosages; Drug-Related Side Effects and Adverse Reactions - epidemiology; Drug-Related Side Effects and Adverse Reactions - pathology; Echinocandins - administration & dosage; Echinocandins - adverse effects; Esophagus; Female; Fever; Fungal infections; Human mycoses; Humans; Infectious diseases; Internal Medicine; Japan; Lipopeptides - administration & dosage; Lipopeptides - adverse effects; Lung; Male; Medical Microbiology; Medical sciences; Medicine; micafungin; Middle Aged; Miscellaneous mycoses; Mycoses; Neutropenia; Patients; Pharmacology. Drug treatments; Prospective Studies; Safety; Statistics; Treatment Outcome; Japan; United States > US; Invasive Candidiasis; Candidiasis; Invasive Aspergillosis; Aspergillosis; Caspofungin; Mycosis; Microbiology; Enzyme; Transferases; Glycosyltransferases; Enzyme inhibitor; 1,3-β-Glucan synthase; Micafungin; Echinocandine derivatives; Infection; Antifungal agent; Treatment; Double blind study; Hexosyltransferases; Comparative study
• ISSN: 0934-9723; 1435-4373
• DOI: 10.1007/s10096-012-1754-z

The safety and efficacy profile of caspofungin and micafungin in Japanese patients with fungal infections were directly compared in this prospective, randomized, double-blind study. The proportion of patients who developed significant drug-related adverse event(s) (defined as a serious drug-related adverse event or a drug-related adverse event leading to study therapy discontinuation) was compared in 120 patients [caspofungin 50 mg, or 50 mg following a 70-mg loading dose on Day 1 (hereinafter, 70/50 mg) group: 60 patients; micafungin 150 mg: 60 patients]. The overall response rate was primarily evaluated in the per-protocol set (PPS) population. The proportion of patients who developed significant drug-related adverse events was 5.0 % (3/60) in the caspofungin group and 10.0 % (6/60) in the micafungin group [95 % confidence interval (CI) for the difference: −15.9 %, 5.2 %]. The favorable overall response in the PPS population for patients with esophageal candidiasis, invasive candidiasis, and chronic pulmonary aspergillosis including aspergilloma was 100.0 % (6/6), 100.0 % (3/3), and 46.7 % (14/30) in the caspofungin group, and 83.3 % (5/6), 100.0 % (1/1), and 42.4 % (14/33) in the micafungin group, respectively. In Japanese patients with
Candida
or
Aspergillus
infections, there was no statistical difference in the safety between caspofungin and micafungin. Consistent with other data on these two agents, the efficacy of caspofungin and micafungin was similar.