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Fluconazole Compared with Ketoconazole for the Treatment of Candida Esophagitis in AIDS: A Randomized Trial

Loren Laine, MD; Robin H. Dretler, MD; Chris N. Conteas, MD; Carmelita Tuazon, MD; Frederick M. Koster, MD; Fred Sattler, MD; Kathleen Squires, MD; and Muhammed Z. Islam, PhD
[+] Article, Author, and Disclosure Information

Grant Support: By Pfizer Central Research.

Requests for Reprints: Loren Laine, MD, GI Division, Department of Medicine, U.S.C. School of Medicine, 2025 Zonal Avenue, Los Angeles, CA 90033.

Current Author Addresses: Dr. Laine: GI Division, Department of Medicine, U.S.C. School of Medicine, 2025 Zonal Avenue, Los Angeles, CA 90033.

Dr. Dretler: Infectious Diseases Specialists of Atlanta, PC, 2801 North Decatur Road, Suite 350, Decatur, GA 30033.

Dr. Conteas: Southern California Permanente Medical Group, 1505 North Edgemont Street, Los Angeles, CA 90027.

Dr. Tuazon: Infectious Diseases Division, George Washington University School of Medicine, 2150 Pennsylvania Avenue, NW, Washington, DC 20037.

Dr. Koster: Infectious Diseases Division, University of New Mexico School of Medicine, Albuquerque, NM 87131.

Dr. Sattler: Department of Medicine, L.A. County-U.S.C. Medical Center, U.S.C. School of Medicine, OPD 5P77, 1175 North Cummings Street, Los Angeles, CA 90033.

Dr. Squires: Infectious Diseases Division, Cornell University Medical College, 1300 York Avenue, New York, NY 10021.

Dr. Islam: Department of Clinical Research, Pfizer Central Research, Eastern Point Road, Groton, CT 06340.

©1992 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1992;117(8):655-660. doi:10.7326/0003-4819-117-8-655
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Objective: To determine the clinical and endoscopic response of Candida esophagitis to antifungal therapy and to compare the two oral antifungal agents, fluconazole and ketoconazole.

Design: Multicenter, randomized, double-blind trial.

Setting: Fifteen U.S. centers including university, private practice, and county hospital settings.

Patients: A total of 169 patients with the acquired immunodeficiency syndrome (AIDS); odynophagia, dysphagia, or retrosternal pain; white esophageal plaques at endoscopy; and pseudohyphae on esophageal brushings or biopsies.

Intervention: Patients were randomly assigned to fluconazole (100 mg/d) or ketoconazole (200 mg/d). Doses were doubled at week 1 or 2 if no symptomatic improvement had occurred during the preceding week. Therapy was continued for 2 weeks after resolution of symptoms or for a maximum of 8 weeks.

Measurements: Patients were clinically evaluated weekly, and laboratory tests were done every 2 weeks. Endoscopy was repeated within 5 days after the end of therapy.

Results: A total of 143 patients were clinically evaluable (assessed within 7 days after therapy), and 129 patients were endoscopically evaluable (endoscopy repeated after therapy). Endoscopic cure occurred in 91% of patients treated with fluconazole and in 52% of those given ketoconazole for a difference of 39% (95% Cl, 24% to 52%; P < 0.001). Esophageal symptoms resolved in 85% of fluconazole-treated patients and in 65% of ketoconazole-treated patients for a difference of 20% (Cl, 6% to 34%; P = 0.006). Intention-to-treat analyses also yielded statistically significant differences for the comparisons listed above. Side effects were minimal and comparable in the two groups; only one patient in each group had therapy discontinued for adverse effects that were possibly related to the study medications.

Conclusions: Fluconazole is associated with significantly greater rates of endoscopic and clinical cure than ketoconazole in patients with AIDS and Candida esophagitis. Both drugs appear to be safe and well tolerated.





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