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


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Title: A double-blind comparative study of the safety and efficacy of caspofungin versus micafungin in the treatment of candidiasis and aspergillosis
Authors: Kohno, Shigeru / Izumikawa, Koichi / Yoshida, Minoru / Takesue, Yoshio / Oka, Shinichi / Kamei, Katsuhiko / Miyazaki, Yoshitsugu / Yoshinari, T. / Kartsonis, Nicholas A. / Niki, Yoshihito
Issue Date: Mar-2013
Publisher: Springer Verlag
Citation: European Journal of Clinical Microbiology & Infectious Diseases, 32(3), pp.387-397; 2013
Abstract: 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.
Keywords: caspofungin / micafungin / aged / alanine aminotransferase blood level / alkaline phosphatase blood level / article / aspartate aminotransferase blood level / aspergilloma / blood pressure / constipation / controlled study / double blind procedure / drug efficacy / drug eruption / drug safety / drug withdrawal / eosinophil count / erythema / esophagus candidiasis / eye disease / female / gamma glutamyl transferase blood level / gastrointestinal disease / heart atrium fibrillation / hepatobiliary disease / human / hypertension / hypesthesia / infection / infestation / injection site reaction / invasive aspergillosis / invasive candidiasis / Japanese / leukocyte count / lung aspergillosis / major clinical study / male / multicenter study / nausea / neurologic disease / phlebitis / population research / potassium blood level / priority journal / prospective study / prothrombin time / randomized controlled trial / side effect / skin disease / thrombocyte count / treatment response / vascular disease
URI: http://hdl.handle.net/10069/31672
ISSN: 09349723
DOI: 10.1007/s10096-012-1754-z
Rights: © The Author(s) 2012. This article is published with open access at Springerlink.com
Type: Journal Article
Text Version: publisher
Appears in Collections:Articles in academic journal

Citable URI : http://hdl.handle.net/10069/31672

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