A Randomized, Double‐Blind, Double‐Dummy, Multicenter Trial of Voriconazole and Fluconazole in the Treatment of Esophageal Candidiasis in Immunocompromised Patients
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The efficacy, safety, and tolerability of voriconazole and fluconazole were compared in 391 immunocompromised patients with mycology- and biopsy-proven esophageal candidiasis. Primary efficacy analysis (256 patients) of esophageal treatment as assessed by esophagoscopy revealed success rates of 98.3% with voriconazole and 95.1% with fluconazole. The 95% confidence interval for the difference in success rates ranged from -1.0% to 7.5%. The overall safety and tolerability of both antifungals were acceptable. Fewer patients discontinued voriconazole treatment because of insufficient clinical response (4 patients [2.0%] vs. 5 patients [2.6%]). More patients discontinued voriconazole than fluconazole treatment because of laboratory test abnormalities (7 patients [3.5%] vs. 2 patients [1.0%]) or treatment-related adverse events (5 patients [2.5%] vs. 1 patient [0.5%]). The most frequent adverse events (23%) with voriconazole were mild, transient visual disturbances. Voriconazole (200 mg, b.i.d.) was shown to be at least as effective as fluconazole in the treatment of biopsy-proven esophageal candidiasis in immunocompromised patients.
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Voriconazole is as active as fluconazole against esophageal candidiasis, although it was associated with more adverse events in a recent study.
“It is as active as fluconazole against esophageal candidiasis, although it was associated with more adverse events in a recent study [46].”
From Guidelines for Treatment of Candidiasis (2004) · cites this paper as [46]
Voriconazole is as efficacious as fluconazole for esophageal candidiasis but is associated with a higher rate of treatment-related adverse events.
“Voriconazole (200 mg b.i.d. for a median duration of 14 days) is as efficacious as fluconazole (400 mg loading dose followed by 200 mg/day for a median duration of 15 days) but is associated with a higher rate of treatment-related adverse events [46].”
From Guidelines for Treatment of Candidiasis (2004) · cites this paper as [46]
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- Authors
- Ally, R., Schürmann, D., Kreisel, W., Carosi, G., Aguirrebengoa, K., Dupont, B., Hodges, M., Troke, P., Romero, A. J., & the Esophageal Candidiasis Study Group
- Affiliations
- Chris Hani Baragwanath Hospital (ZA)
- Humboldt-Universität zu Berlin (DE)
- University of Freiburg (DE)
- University of Brescia (IT)
- Hospital de Cruces (ES)
- Institut Pasteur (FR)
- Pfizer (United Kingdom) (GB)
- Corresponding author
- Dupont, B.
- Venue
- Clinical Infectious Diseases
- Publisher
- Oxford University Press (OUP)
- Published
- 2001-11
- Volume
- 33
- Issue
- 9
- Pages
- 1447-1454
- ISSN
- 1058-4838 (ISSN-L)
- 1537-6591
- OpenAlex
- W2027962943
- Cited by
- 331
- References
- 34
- Citations by year
- 2026: 2 · 2025: 4 · 2024: 6 · 2022: 5 · 2021: 4 · 2020: 3 · 2019: 5 · 2018: 1 · 2017: 9 · 2016: 9 · 2015: 15 · 2014: 11 · 2013: 9 · 2012: 11
- FWCI
- 20.96
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Clinical Infectious Diseases (publishedVersion)
- PubMed (publishedVersion)
- INFM-OAR (INFN Catania) (submittedVersion, other-oa)
- Topics
- Health Sciences › Medicine › Infectious Diseases › Antifungal resistance and susceptibility
- Health Sciences › Medicine › Epidemiology › Fungal Infections and Studies
- Health Sciences › Medicine › Ophthalmology › Ocular Infections and Treatments
- Keywords
- esophageal candidiasis, voriconazole, fluconazole, immunocompromised patients, antifungal therapy, treatment efficacy, adverse events, visual disturbances, esophagoscopy
- MeSH terms
- Adolescent, Adult, Aged, Antifungal Agents, Candidiasis, Consumer Product Safety, Double-Blind Method, Esophageal Diseases, Female, Humans, Male, Microbial Sensitivity Tests, Middle Aged, Pyrimidines, Triazoles, Fluconazole, Immunocompromised Host, Treatment Outcome, Voriconazole
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