Low-dose ketoconazole-fluconazole combination versus fluconazole in single doses for the treatment of vaginal candidiasis
Background: Vaginal candidiasis (VC) is one of the most common fungal diseases. Candida albicans is the most commonÂ causative fungus and has been isolated from more than 80% of specimens obtained from women with VC. KetoconazoleÂ is the first orally active antifungal, the dosage for VC is 200 mg twice daily for 5 days. Fluconazole is the newer oralÂ antifungal, its dosage for VC is a single oral dose of 150 mg. Since fluconazole 150 mg is considerably expensive, aÂ single dose of 100 mg ketoconazole and 40 mg fluconazole in combination has been tested for the treatment of VC. TheÂ results showed that from 11 women with confirmed VC, 1-2 weeks after drug administration, the mycological cultureÂ was negative in 8 women, positive in 1 woman, and 2 woman lost to follow-up. This promising result led to the presentÂ study with the objective to confirm the efficacy and safety of the above combination in a formal clinical trial.
Methods: A total of 165 female patients, aged 18 years or older, with the diagnosis of VC from clinical symptomsÂ (pruritus or burning or excessive discharge) and positive microscopic smear (pseudohyphae and/or yeast cells) wereÂ randomized to receive a single dose of either keto-fluco combination (n = 85) or fluconazole (n = 80), and returned
for follow-up visit on day 8.
Results: Among these patients, 39 patients had negative baseline culture, leaving 126 patients eligible for efficacyÂ evaluation. The mycological eradication in the keto-fluco group was 74.5% (41 patients from a total of 55 patientsÂ with available mycological culture), while that in the fluconazole group was 70.2% (40 patients from 57 patientsÂ with available culture) and this difference was not significant. The clinical favorable response (clinical cure andÂ clinical improvement) in the keto-fluco arm (n = 60) was 98.3%, while that in the fluconazole group (n = 66) wasÂ 100%. Adverse events were found in 5 patients, 3 patients in the keto-fluco group (3/85 = 3.5%) and 2 patients in theÂ fluconazole group (2/80 = 2.5%).
Conclusion: The present study showed that the efficacy and safety of ketoconazole 100 mg and fluconazole 40 mgÂ combination was not inferior compared to fluconazole 150 mg in single doses for the treatment of vaginal candidiasis.Â (Med J Indones 2011; 20:205-11)
Keywords: fluconazole, low-dose ketoconazole-fluconazole combination, single dose, vaginal candidiasis
Copyright (c) 2011 Jan Susilo, Arini Setiawati, Iwan Darmansjah, Junita Indarti, Fitriyadi Kusuma
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