OBJECTIVES: To evaluate the efficacy and safety of low-dose antifungals as prophylaxis of recurrent esophageal candidiasis after the first episode in patients with AIDS. METHODS: After the first episode of esophageal candidiasis, 122 consecutive AIDS patients were randomly assigned to two different regimens of continuous long-term antifungal prophylaxis (ketoconazole 200 mg or fluconazole 50 mg/day p.o.) or no antifungal therapy over a period of 2 yr. Patients were followed up by monthly clinical controls and upper GI endoscopy in the case of recurrence of esophageal symptoms. RESULTS: One hundred and six patients were clinically evaluable over a mean observation time of 7.5 months. Prophylaxis with oral antifungals significantly reduced symptomatic relapses of esophageal candidiasis, the cumulative probability of relapse at 12 months being 38% in the prophylaxis group, compared with 84% in the untreated group. Both antifungals were sufficiently safe and well tolerated. The clinical response of a second episode of candidiasis to the reintroduction of standard oral antifungals was markedly worse in patients on prophylaxis (especially with ketoconazole) than in untreated patients, presumably due to the development of resistance to the antifungal. CONCLUSIONS: Continuous prophylaxis with both-fluconazole and ketoconazole is effective in preventing recurrences of Candida esophagitis in AIDS patients; however, the possible emergence of strains resistant to these antifungals, as well as the high cost of the therapy, should raise doubts as to whether or not this type of prophylaxis should be extended to all AIDS patients with Candida esophagitis, rather than to limit its use to specific subgroups of patients, such as those with frequent symptomatic relapses.
RCT Entities:
OBJECTIVES: To evaluate the efficacy and safety of low-dose antifungals as prophylaxis of recurrent esophageal candidiasis after the first episode in patients with AIDS. METHODS: After the first episode of esophageal candidiasis, 122 consecutive AIDSpatients were randomly assigned to two different regimens of continuous long-term antifungal prophylaxis (ketoconazole 200 mg or fluconazole 50 mg/day p.o.) or no antifungal therapy over a period of 2 yr. Patients were followed up by monthly clinical controls and upper GI endoscopy in the case of recurrence of esophageal symptoms. RESULTS: One hundred and six patients were clinically evaluable over a mean observation time of 7.5 months. Prophylaxis with oral antifungals significantly reduced symptomatic relapses of esophageal candidiasis, the cumulative probability of relapse at 12 months being 38% in the prophylaxis group, compared with 84% in the untreated group. Both antifungals were sufficiently safe and well tolerated. The clinical response of a second episode of candidiasis to the reintroduction of standard oral antifungals was markedly worse in patients on prophylaxis (especially with ketoconazole) than in untreated patients, presumably due to the development of resistance to the antifungal. CONCLUSIONS: Continuous prophylaxis with both-fluconazole and ketoconazole is effective in preventing recurrences of Candida esophagitis in AIDSpatients; however, the possible emergence of strains resistant to these antifungals, as well as the high cost of the therapy, should raise doubts as to whether or not this type of prophylaxis should be extended to all AIDSpatients with Candida esophagitis, rather than to limit its use to specific subgroups of patients, such as those with frequent symptomatic relapses.
Authors: Natalya U Makarova; V V Pokrowsky; A V Kravchenko; L V Serebrovskaya; Michael J James; Michael M McNeil; Brent A Lasker; David W Warnock; Errol Reiss Journal: J Clin Microbiol Date: 2003-05 Impact factor: 5.948