Intravenous anidulafungin followed optionally by oral voriconazole for the treatment of candidemia in Asian patients: results from an open-label Phase III trial

BMC Infectious Diseases

Moh-Lim Ong²  Viraj Rajadhyaksha³  Vilma M Co⁵  Deepak Talwar¹  Po-Ren Hsueh⁶  Piroon Mootsikapun⁴ 

[1] Metro Hospitals, Noida, India;Pfizer Inc., New York, NY, USA;Medical Research Division, Pfizer Ltd, Jogeshwari Mumbai, India;Department of Medicine, Srinagarind Hospital, Khon Kaen, Thailand;Makati Medical Center, Makati City, Philippines;Departments of Laboratory Medicine and Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan

关键词: Asia;    Candidemia;    Anidulafungin;   

Others  :  1148396
DOI  :  10.1186/1471-2334-13-219

 received in 2012-07-23, accepted in 2013-05-07,  发布年份 2013

【 摘 要 】

Background

Candidemia is a significant cause of morbidity and mortality in hospitalized patients, particularly in Asia. Anidulafungin has been reported to be an effective treatment for candidemia in Western populations, but little is known about its efficacy in Asian patients, where the clinical presentation and epidemiology may be different.

Methods

An open-label study of anidulafungin for the treatment of candidemia was recently conducted in several Asian countries. Treatment was initiated with intravenous anidulafungin, given for at least 5 days, with the option to complete treatment with oral voriconazole. The primary endpoint was global (clinical and microbiological) response, and the primary analysis was the proportion of patients in the modified intent-to-treat population with successful global response at the end of therapy. Secondary analyses included proportion with successful global response in clinically relevant patient subgroups. The safety and tolerability profile of anidulafungin and voriconazole in this population was also investigated.

Results

Forty-three patients were studied, including 42 in the modified intent-to-treat population. Eighteen patients were > 65 years, the largest age subgroup, and 21 had central venous catheters. The most common Candida species causing infection were C. tropicalis (n = 18) and C. albicans (n = 10). In the primary analysis, 73.8% had a successful global response at end of therapy. Success rates in subgroups were: 72.2% for C. tropicalis and 71.4% for C. albicans infection, 58.8% for patients > 65 years, and 81.0% for patients with central venous catheters. Safety and tolerability were comparable with the known profiles for anidulafungin (and voriconazole).

Conclusions

Although the epidemiology of Candida infections was different in this open-label study, the efficacy of anidulafungin in Asian patients with documented candidemia was consistent with previous studies in Western populations. No new safety concerns were identified.

Trial registration

http://www.clinicaltrials.gov webcite identifier NCT00537329

【 授权许可】

   
2013 Mootsikapun et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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