TY - JOUR
T1 - Anidulafungin compared with fluconazole in severely ill patients with candidemia and other forms of invasive candidiasis
T2 - Support for the 2009 IDSA treatment guidelines for candidiasis
AU - Kett, Daniel H.
AU - Shorr, Andrew F.
AU - Reboli, Annette C.
AU - Reisman, Arlene L.
AU - Biswas, Pinaki
AU - Schlamm, Haran T.
N1 - Funding Information:
The original clinical trial was sponsored by Vicuron; Vicuron was acquired by Pfizer Inc. in July 2005. The analyses described in this article were undertaken by Pfizer Inc., and all authors had access to the resultant data. Editorial assistance was provided by D Wolf, of Parexel, and Fiona Boswell, PhD, at Complete Medical Communications, and was funded by Pfizer Inc.
Funding Information:
DHK has received research support from Akers Bioscience, Astellas, Biogel/ Hibiclens, Ortho-McNeil, and Pfizer; has been a consultant to Astellas, Lilly, and Pfizer; and has served as a speaker for Astellas, Cubist, Glaxo, Lilly, Ortho-McNeil, Pfizer, and Wyeth. AFS has served as a consultant to, speaker for, and/or has received research support from Astellas, Merck, and Pfizer. ACR has received clinical research grant support from Merck and Pfizer, has been a consultant for Merck and Pfizer, and has been a lecturer for Pfizer. ALR, PB, and HTS are employees of Pfizer Inc.
PY - 2011/10/25
Y1 - 2011/10/25
N2 - Introduction: During the past decade, the incidence of Candida infections in hospitalized patients has increased, with fluconazole being the most commonly prescribed systemic antifungal agent for these infections. However, the 2009 Infectious Diseases Society of America (IDSA) candidiasis guidelines recommend an echinocandin for the treatment of candidemia/invasive candidiasis in patients who are considered to be "moderately severe or severely" ill. To validate these guidelines, clinical trial data were reviewed.Methods: A secondary analysis of data from a previously published prospective, randomized, double-blind clinical trial was performed; it compared anidulafungin with fluconazole for the treatment of invasive candidiasis and candidemia. Patients with critical illness were identified at study entry by using the following criteria: Acute Physiology and Chronic Health Evaluation (APACHE) II score of ≥ 15, evidence of severe sepsis (sepsis and one or more end-organ dysfunctions) present, and/or patient was in intensive care. Global response rates were compared at the end of intravenous study treatment (the primary end point of the original study) and all-cause mortality at 14 and 28 days from study entry in this group.Results: The patients (163 (66.5%) of 245) fulfilled at least one criterion for critical illness (anidulafungin, n = 89; fluconazole, n = 74). No significant differences were found in baseline characteristics between the two treatment groups. The global response rate was 70.8% for anidulafungin and 54.1% for fluconazole (P = 0.03; 95% confidence interval (CI): 2.0 to 31.5); all-cause mortality was 10.1% versus 20.3% at 14 days (P = 0.08; 95% CI, -0.9 to 21.3) and was 20.2% versus 24.3% at 28 days (P = 0.57; 95% CI, -8.8 to 17.0) for anidulafungin and fluconazole, respectively.Conclusions: In this post hoc analysis, anidulafungin was more effective than fluconazole for treatment of severely ill patients with candidemia, thus supporting the 2009 IDSA guidelines.Trial registration: Clinicaltrials.gov NCT00058682.
AB - Introduction: During the past decade, the incidence of Candida infections in hospitalized patients has increased, with fluconazole being the most commonly prescribed systemic antifungal agent for these infections. However, the 2009 Infectious Diseases Society of America (IDSA) candidiasis guidelines recommend an echinocandin for the treatment of candidemia/invasive candidiasis in patients who are considered to be "moderately severe or severely" ill. To validate these guidelines, clinical trial data were reviewed.Methods: A secondary analysis of data from a previously published prospective, randomized, double-blind clinical trial was performed; it compared anidulafungin with fluconazole for the treatment of invasive candidiasis and candidemia. Patients with critical illness were identified at study entry by using the following criteria: Acute Physiology and Chronic Health Evaluation (APACHE) II score of ≥ 15, evidence of severe sepsis (sepsis and one or more end-organ dysfunctions) present, and/or patient was in intensive care. Global response rates were compared at the end of intravenous study treatment (the primary end point of the original study) and all-cause mortality at 14 and 28 days from study entry in this group.Results: The patients (163 (66.5%) of 245) fulfilled at least one criterion for critical illness (anidulafungin, n = 89; fluconazole, n = 74). No significant differences were found in baseline characteristics between the two treatment groups. The global response rate was 70.8% for anidulafungin and 54.1% for fluconazole (P = 0.03; 95% confidence interval (CI): 2.0 to 31.5); all-cause mortality was 10.1% versus 20.3% at 14 days (P = 0.08; 95% CI, -0.9 to 21.3) and was 20.2% versus 24.3% at 28 days (P = 0.57; 95% CI, -8.8 to 17.0) for anidulafungin and fluconazole, respectively.Conclusions: In this post hoc analysis, anidulafungin was more effective than fluconazole for treatment of severely ill patients with candidemia, thus supporting the 2009 IDSA guidelines.Trial registration: Clinicaltrials.gov NCT00058682.
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U2 - 10.1186/cc10514
DO - 10.1186/cc10514
M3 - Article
C2 - 22026929
AN - SCOPUS:80054866137
VL - 15
JO - Critical Care
JF - Critical Care
SN - 1364-8535
IS - 5
M1 - R253
ER -