Clinical evaluation of terconazole. United states experience

Terconazole is the first of a new class of antifungal agents, the triazoles. The results of numerous European studies have demonstrated the efficacy and safety of this agent in both cream and suppository form in the treatment of vulvovaginal candidiasis. Recently, results of short- and long-term analyses in the United States confirmed the efficacy and safety of 0.4% terconazole cream and 80-mg terconazole suppositories. In short-term evaluations (eight to ten days after therapy), 0.4% terconazole cream was as effective as 2.0% miconazole nitrate cream and significantly superior microbiologically in one study. The clinical cure rates with terconazole cream ranged from 87.3% to 95.5% and the microbiologic cure rates, from 76.9% to 91.1%. Thirty- to 35-day microbiologic relapse rates with terconazole cream ranged from 10.4% to 22.2%. In the short-term evaluations of vaginal suppositories the cure rates of 80-mg terconazole suppositories for three days were comparable to those of 100-mg miconazole nitrate suppositories for seven days. The clinical cure rates with 80-mg terconazole suppositories ranged from 90.0% to 92.2% and the microbiologic cure rates, from 80.4% to 85.0%. The 30- to 35-day microbiologic relapse rates of the 80-mg terconazole suppositories ranged from 20.0% to 28.1%. Terconazole cream and suppositories demonstrated an excellent safety profile in all the studies; no life-threatening side effects occurred with any of the regimens. The frequency of common side effects was similar with terconazole and miconazole nitrate formulations.