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

R. Ally, D. Schürmann, W. Kreisel, G. Carosi, K. Aguirrebengoa, Bertrand Dupont, M. Hodges, P. Troke, A. J. Romero, A. De Alarcon Gonzales, Y. Benhamou, J. S. Bingham, J. Sola Boneta, B. De Rienzo, W. W. Dinsmore, G. Fatkenheuer, R. J. Garsia, D. Fountas, J. A. Gastaut, F. GrittiD. A. Hawkins, W. Heise, S. Jarauratanasirikul, D. W. Johnson, M. Johnson, D. Lacoste, R. H. Lawrence, R. Lowenthal, G. Madej, D. Marriott, F. Menichetti, M. Moroni, F. M. Mulcahy, P. Narciso, F. Raffi, M. A. Reiger, J. H R Reynes, I. O. Rivera, P. Sabballs-Radresa, M. A. Sambeat, J. M. Santamaria, V. G. Savchenko, F. Scholte, U. Schwegler, M. Shahmanesh, A. E. Simjee, A. Stoehr, K. Supparatpinyo, B. A. Sze Peng, S. Tansuphaswadikul, J. De La Torre Cisneros, J. H. Van Zyl, M. N. Vetter, M. Whitby, T. A. Winter

Research output: Contribution to journalArticlepeer-review

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 biopsyproven esophageal candidiasis in immunocompromised patients.

Original languageEnglish
Pages (from-to)1447-1454
Number of pages8
JournalClinical Infectious Diseases
Volume33
Issue number9
DOIs
Publication statusPublished - Nov 1 2001

ASJC Scopus subject areas

  • Immunology

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