Loren Laine, MD; Robin H. Dretler, MD; Chris N. Conteas, MD; Carmelita Tuazon, MD; Frederick M. Koster, MD; Fred Sattler, MD; Kathleen Squires, MD; Muhammed Z. Islam, PhD
Laine L, Dretler RH, Conteas CN, Tuazon C, Koster FM, Sattler F, et al. Fluconazole Compared with Ketoconazole for the Treatment of Candida Esophagitis in AIDS: A Randomized Trial. Ann Intern Med. 1992;117:655-660. doi: 10.7326/0003-4819-117-8-655
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Published: Ann Intern Med. 1992;117(8):655-660.
▪ 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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Gastroenterology/Hepatology, Infectious Disease, Esophageal Disorders.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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