A randomized, double-blind, double-dummy, multicenter trial of voriconazole and fluconazole in the treatment of esophageal candidiasis in immunocompromised patients

Citation
R. Ally et al., A randomized, double-blind, double-dummy, multicenter trial of voriconazole and fluconazole in the treatment of esophageal candidiasis in immunocompromised patients, CLIN INF D, 33(9), 2001, pp. 1447-1454
Citations number
37
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Clinical Immunolgy & Infectious Disease",Immunology
Journal title
CLINICAL INFECTIOUS DISEASES
ISSN journal
1058-4838 → ACNP
Volume
33
Issue
9
Year of publication
2001
Pages
1447 - 1454
Database
ISI
SICI code
1058-4838(20011101)33:9<1447:ARDDMT>2.0.ZU;2-N
Abstract
The efficacy, safety, and tolerability of voriconazole and fluconazole were compared in 391 immunocompromised patients with mycology- and biopsy-prove n esophageal candidiasis. Primary efficacy analysis (256 patients) of esoph ageal 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 patient s discontinued voriconazole treatment because of insufficient clinical resp onse (4 patients [2.0%] vs. 5 patients [2.6%]). More patients discontinued voriconazole than fluconazole treatment because of laboratory test abnormal ities (7 patients [3.5%] vs. 2 patients [1.0%]) or treatment-related advers e events (5 patients [2.5%] vs. 1 patient [0.5%]). The most frequent advers e events (23%) with voriconazole were mild, transient visual disturbances. Voriconazole (200 mg, b. i. d.) was shown to be at least as effective as fl uconazole in the treatment of biopsy-proven esophageal candidiasis in immun ocompromised patients.