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CLINICAL TRIAL
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
Fluconazole compared with endoscopy for human immunodeficiency virus-infected patients with esophageal symptoms.
Gastroenterology 1996 June
BACKGROUND & AIMS: The best initial treatment of human immunodeficiency virus (HIV)-infected patients with esophageal symptoms is unknown. The outcome, including safety and cost-effectiveness, of fluconazole compared with endoscopy as a treatment strategy for HIV-infected patients with new-onset esophageal symptoms was evaluated.
METHODS: During a 53-month period, 134 HIV-infected patients with esophageal symptoms were randomized prospectively to groups receiving either standard doses of fluconazole or endoscopy.
RESULTS: Among the 68 patients in the fluconazole group, a complete symptomatic response was observed in 56 patients (82%), usually within 1 week. The most common endoscopic findings in the 66 patients in the endoscopy group included Candida esophagitis alone in 42 patients (64%) and ulcerative esophagitis in 10 patients (15%). Patients responding to empirical antifungal therapy or who had Candida esophagitis alone at endoscopy were less like to have severe symptoms (P = 0.027) or odynophagia as the only symptom (P < 0.001) but more frequently had odynophagia and dysphagia (P = 0.007) and thrush (P = 0.002). Empirical fluconazole was cost-effective, saving $738.16 per patient.
CONCLUSIONS: Empirical oral antifungal therapy with fluconazole is highly efficacious, safe, and cost-effective for HIV-infected patients with new-onset esophageal symptoms.
METHODS: During a 53-month period, 134 HIV-infected patients with esophageal symptoms were randomized prospectively to groups receiving either standard doses of fluconazole or endoscopy.
RESULTS: Among the 68 patients in the fluconazole group, a complete symptomatic response was observed in 56 patients (82%), usually within 1 week. The most common endoscopic findings in the 66 patients in the endoscopy group included Candida esophagitis alone in 42 patients (64%) and ulcerative esophagitis in 10 patients (15%). Patients responding to empirical antifungal therapy or who had Candida esophagitis alone at endoscopy were less like to have severe symptoms (P = 0.027) or odynophagia as the only symptom (P < 0.001) but more frequently had odynophagia and dysphagia (P = 0.007) and thrush (P = 0.002). Empirical fluconazole was cost-effective, saving $738.16 per patient.
CONCLUSIONS: Empirical oral antifungal therapy with fluconazole is highly efficacious, safe, and cost-effective for HIV-infected patients with new-onset esophageal symptoms.
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