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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.

Kohno S, Izumikawa K, Yoshida M, Takesue Y, Oka S, Kamei K, Miyazaki Y, Yoshinari T, Kartsonis NA, Niki Y - Eur. J. Clin. Microbiol. Infect. Dis. (2012)

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: Department of Molecular Microbiology and Immunology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki 852-8501, Japan.

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.

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Related in: MedlinePlus

Analysis populations and reasons for exclusion by treatment group. APaT: all patients as treated, FAS: full analysis set, PPS: per-protocol set
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Fig1: Analysis populations and reasons for exclusion by treatment group. APaT: all patients as treated, FAS: full analysis set, PPS: per-protocol set

Mentions: The breakdown of APaT, FAS, PPS and populations in this study and the reasons for the exclusion of patients from each population is included in Fig. 1. One patient was excluded from the APaT population because blinding was not maintained for this patient. Thirteen patients who were diagnosed as having infections caused by pathogens other than Aspergillus spp. and Candida spp., based on the determination of the IEAC, were excluded from the FAS population. The most common reason for why patients were excluded from the FAS population and the PPS population was unconfirmed “positive culture” for esophageal candidiasis and invasive candidiasis (15 patients). Most of these excluded patients were with probable candidemia. Candidemia patients were allowed to start study therapy based on the positive (1,3)-β-D-glucan test and clinical symptoms, and, as a result, most of the culture results in these patients were demonstrated as negative. Patients who were not classified into diseases predefined in the study protocol (two patients with aspergillosis not classified) were also excluded from the PPS population. In addition, there were exclusions due to the use of prohibited concomitant drugs (one patient) and insufficient study therapy duration (four patients). There was no notable difference in the number of patients within each treatment group in any of the three analysis populations.Fig. 1


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

Kohno S, Izumikawa K, Yoshida M, Takesue Y, Oka S, Kamei K, Miyazaki Y, Yoshinari T, Kartsonis NA, Niki Y - Eur. J. Clin. Microbiol. Infect. Dis. (2012)

Analysis populations and reasons for exclusion by treatment group. APaT: all patients as treated, FAS: full analysis set, PPS: per-protocol set
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3569581&req=5

Fig1: Analysis populations and reasons for exclusion by treatment group. APaT: all patients as treated, FAS: full analysis set, PPS: per-protocol set
Mentions: The breakdown of APaT, FAS, PPS and populations in this study and the reasons for the exclusion of patients from each population is included in Fig. 1. One patient was excluded from the APaT population because blinding was not maintained for this patient. Thirteen patients who were diagnosed as having infections caused by pathogens other than Aspergillus spp. and Candida spp., based on the determination of the IEAC, were excluded from the FAS population. The most common reason for why patients were excluded from the FAS population and the PPS population was unconfirmed “positive culture” for esophageal candidiasis and invasive candidiasis (15 patients). Most of these excluded patients were with probable candidemia. Candidemia patients were allowed to start study therapy based on the positive (1,3)-β-D-glucan test and clinical symptoms, and, as a result, most of the culture results in these patients were demonstrated as negative. Patients who were not classified into diseases predefined in the study protocol (two patients with aspergillosis not classified) were also excluded from the PPS population. In addition, there were exclusions due to the use of prohibited concomitant drugs (one patient) and insufficient study therapy duration (four patients). There was no notable difference in the number of patients within each treatment group in any of the three analysis populations.Fig. 1

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: Department of Molecular Microbiology and Immunology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki 852-8501, Japan.

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.

Show MeSH
Related in: MedlinePlus