title: A randomized, double-blind, double-dummy, multicenter trial of voriconazole and fluconazole in the treatment of esophageal candidiasis in immunocompromised patients.
abstract: 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.
authors.affiliation: Department of Gastroenterology, Chris Hani, Baragwanath Hospital, Johannesburg, South Africa.
authors.forename: R
authors.initials: R
authors.lastname: Ally
authors.forename: D
authors.initials: D
authors.lastname: Schürmann
authors.forename: W
authors.initials: W
authors.lastname: Kreisel
authors.forename: G
authors.initials: G
authors.lastname: Carosi
authors.forename: K
authors.initials: K
authors.lastname: Aguirrebengoa
authors.forename: B
authors.initials: B
authors.lastname: Dupont
authors.forename: M
authors.initials: M
authors.lastname: Hodges
authors.forename: P
authors.initials: P
authors.lastname: Troke
authors.forename: A J
authors.initials: AJ
authors.lastname: Romero
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002177:Candidiasis / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D003257:Consumer Product Safety; D004311:Double-Blind Method; D004935:Esophageal Diseases / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D005260:Female; D015725:Fluconazole / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D016867:Immunocompromised Host; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014230:Triazoles / Q000009:adverse effects / Q000627:therapeutic use*; D065819:Voriconazole
chemical_list: D000935:Antifungal Agents; D011743:Pyrimidines; D014230:Triazoles; D015725:Fluconazole; D065819:Voriconazole