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participating institutions:
Johns Hopkins University AIDS Service, New York State DOH AIDS Institute, The CORE Center, Cook County Hospital



NEWS AND NEW DEVELOPMENTS



A Randomized, Double-Blind, Double-Dummy, Multicenter Trial of Voriconazole and Fluconazole in the Treatment of Esophageal Candidiasis in Immunocompromised Patients [Ally R et al. CID 2001;33:1447] The authors report a controlled trial of voriconazole (200 mg bid) vs. fluconazole (400 mg on day one, than 200 mg q/day) in 391 patients from 15 countries with endoscopy confirmed esophageal candidiasis. The median duration of treatment was 14-15 days. Cultures were routinely performed and yielded C. albicans in 354 of the 362 of strains that were speciated. Results showed no significant difference in outcome between the two groups in terms of response by endoscopy (98 vs. 95% for voriconazole vs. fluconazole, respectively), clinical response, or in the frequency of adverse affects. The most common adverse affect in voriconazole recipients was visual changes in 18%, primarily "mild enhancement or alteration of visual perception." These changes were transient and disappeared, usually with continued treatment. None of these patients had long-term visual sequelae. The results of the trial are summarized in the following table:

Treatment of Candida esophagitis
  Voriconazole
n = 200
Fluconazole
n = 191
Cure
    Endoscopy 98.3% 95.1%
    Clinical 88.0% 91.1%
Adverse effects
    D/C therapy 2.5% 0.5%

Comment: This study compares two Pfizer-produced drugs in a well-controlled trial of Candida esophagitis. Voriconazole is a new triazole, which is 10- to 500-fold more active than fluconazole against many fungal pathogens including fluconazole-resistant Candida. His study showed that it was as effective as fluconazole, although the trial did not adequately test its activity for fluconazole-resistant strains. The side effect profile seemed acceptable. The drug is before the FDA at the present time.
posted 11/19/2001





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