OBJECTIVE: To compare the safety and efficacy of fluconazole 150mg single dose and itraconazole 200mg per day for 3 days in the treatment of the acute episode of vulvovaginal candidiasis (VVC). METHODS: Double-blind randomized study conducted in three University centers. Patients with acute clinically and mycologically confirmed VVC were enrolled. RESULTS: A total of 86 patients were enrolled; of them, 38 fluconazole and 32 itraconazole patients were evaluable. At the Day 7 visit, all but one fluconazole patients were cured or improved with eradication of the baseline pathogen obtained in all but two itraconazole patients. At the Day 21 visit, a 13% relapse rate was observed in both groups with all other patients cured or improved; eradication rates were 76% for fluconazole and 66% for itraconazole. Global symptom scores (GSS) were significantly more severe at baseline in fluconazole patients (P=0.003). Nevertheless, the slope of the GSS decrease between baseline and Day 7 was similar for both groups whilst GSS were identical at the last visit. Nineteen fluconazole patients reported 31 adverse events and 15 itraconazole patients reported 30 adverse events. CONCLUSIONS: Both oral antifungal treatments showed good clinical and mycological efficacy on the acute episode of VVC with a dramatic decrease of signs and symptoms 7 days after treatment initiation. Fluconazole in single dose warrants optimal compliance in patients who frequently experience more than one episode of VVC.
Fluconazole 150 mg single dose versus itraconazole 200 mg per day for 3 days in the treatment of acute vaginal candidiasis: a double-blind randomized study
GENAZZANI, ANDREA
2003-01-01
Abstract
OBJECTIVE: To compare the safety and efficacy of fluconazole 150mg single dose and itraconazole 200mg per day for 3 days in the treatment of the acute episode of vulvovaginal candidiasis (VVC). METHODS: Double-blind randomized study conducted in three University centers. Patients with acute clinically and mycologically confirmed VVC were enrolled. RESULTS: A total of 86 patients were enrolled; of them, 38 fluconazole and 32 itraconazole patients were evaluable. At the Day 7 visit, all but one fluconazole patients were cured or improved with eradication of the baseline pathogen obtained in all but two itraconazole patients. At the Day 21 visit, a 13% relapse rate was observed in both groups with all other patients cured or improved; eradication rates were 76% for fluconazole and 66% for itraconazole. Global symptom scores (GSS) were significantly more severe at baseline in fluconazole patients (P=0.003). Nevertheless, the slope of the GSS decrease between baseline and Day 7 was similar for both groups whilst GSS were identical at the last visit. Nineteen fluconazole patients reported 31 adverse events and 15 itraconazole patients reported 30 adverse events. CONCLUSIONS: Both oral antifungal treatments showed good clinical and mycological efficacy on the acute episode of VVC with a dramatic decrease of signs and symptoms 7 days after treatment initiation. Fluconazole in single dose warrants optimal compliance in patients who frequently experience more than one episode of VVC.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
