Topical treatment of vaginal candidosis with sertaconazole and econazole sustained-release suppositories

Objective: To compare the efficacy and safety of sertaconazole and econazol e sustained-release suppositories in the treatment of vulvovaginal candidos is. Study design: 369 women with symptoms and signs of vulvovaginitis were enrolled in this multicenter, randomized, double-blind study. After clinica l examination and vaginal sampling, 183 women were treated with a 300-mg se rtaconazole suppository and the other 186 with a 150-mg econazole supposito ry. They were evaluated 1 week after treatment and those who were clinicall y uncured received a second suppository and were re-assessed 1 week later. All women were evaluated 1 month after the last administration. At each fol low-up visit, clinical efficacy was assessed and a vaginal sampling was per formed for microscopic examination and culture. Results: Of the 369 women i ncluded, only the 310 who had a positive culture for a strain of Candida we re taken into account for efficacy analysis: 150 in the sertaconazole group and 160 in the econazole group. One hundred and five women (49 in the sert aconazole group and 56 in the econazole group) were not clinically cured af ter 1 week and received a second suppository. There were no differences bet ween the two groups for the rates of clinical recovery (disappearance of si gns and symptoms) and mycological recovery (negative culture), 1 week after the first application (62.1 and 67.7%, respectively). 1 week after the sec ond application for women treated twice (72.3 and 80.6%, respectively) and for all patients 1 month after the last application (65.3 and 62.0%. respec tively). Among the patients cured 1 week after the last application, the my cological recurrence rate after 1 month was significantly higher in the eco nazole group (32.7 vs. 19.8%, P = 0.035). There was a trend towards better efficacy of sertaconazole after the first application, whereas the two trea tments had similar efficacy in women treated twice. There were no serious a dverse events and only local irritation was reported, without any statistic ally significant difference between the two groups. Conclusion: Single topi cal administration of sertaconazole and econazole had similar efficacy and safety but the former is associated with a lower rate of mycological recurr ence one month after achieving a negative culture. (C) 2000 International F ederation of Gynecology and Obstetrics. All rights reserved.