A double-blind comparative study of the safety and efficacy of caspofungin versus micafungin in the treatment of candidi
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ARTICLE
A double-blind comparative study of the safety and efficacy of caspofungin versus micafungin in the treatment of candidiasis and aspergillosis S. Kohno & K. Izumikawa & M. Yoshida & Y. Takesue & S. Oka & K. Kamei & Y. Miyazaki & T. Yoshinari & N. A. Kartsonis & Y. Niki
Received: 26 June 2012 / Accepted: 19 September 2012 / Published online: 3 October 2012 # The Author(s) 2012. This article is published with open access at Springerlink.com
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 perprotocol set (PPS) population. The proportion of patients who developed significant drug-related adverse events was S. Kohno : K. Izumikawa (*) Department of Molecular Microbiology and Immunology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki 852-8501, Japan e-mail: [email protected] M. Yoshida Fourth Department of Internal Medicine, Teikyo University School of Medicine, Mizonokuchi Hospital, Kanagawa, Japan Y. Takesue Department of Infection Control and Prevention, Hyogo College of Medicine, Hyogo, Japan S. Oka AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan
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.
K. Kamei Department of Clinical Research, Medical Mycology Research Center, Chiba University, Chiba, Japan Y. Miyazaki Department of Chemotherapy and Mycoses, National Institute of Infectious Diseases, Tokyo, Japan T. Yoshinari Japan Development, Vaccine and Infectious Diseases, MSD K.K., Tokyo, Japan N. A. Kartsonis Clinical Research, Infectious Diseases, Merck Research Laboratories, Merck Research Institute, Upper Gwynedd, West Point, PA, USA Y. Niki Development for Clinical Infectious Diseases, Showa University, Tokyo, Japan
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Introduction The importance of deep-seated fungal
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