Abstract
BackgroundAstodrimer Gel contains a novel dendrimer intended to treat and prevent bacterial vaginosis. We assessed the efficacy and safety of Astodrimer Gel for treatment of bacterial vaginosis.Methods132 women with bacterial vaginosis were randomized 1:1:1:1 to Astodrimer 0.5% (N = 34), 1% (N = 33), or 3% (N = 32) Gel or hydroxyethyl cellulose placebo gel (N = 33) at a dose of 5 g vaginally once daily for 7 days at 6 centers in the United States. The primary endpoint was clinical cure (no bacterial vaginosis vaginal discharge and no more than one of 1) vaginal pH ≥4.5; 2) ≥20% clue cells; or 3) positive whiff test) at study days 21–30. Secondary analyses included clinical cure at study days 9–12, patient-reported symptoms, acceptability and adverse events.ResultsThe Astodrimer 1% Gel dose was superior to placebo for the primary and selected secondary efficacy measures in the modified intent-to-treat population. Clinical cure rates at day 9–12 were superior to placebo for the Astodrimer 3%, 1% and 0.5% Gel groups (62.5% [15/24; P = .002], 74.1% [20/27; P < .001], and 55.2% [16/29; P = .001], respectively, vs. 22.2% [6/27]). At day 21–30, clinical cure rates were 46.2% (12/26) for the 1% dose vs. 11.5% for placebo (3/26; P = .006). A greater proportion of patients reported absence of vaginal discharge and vaginal odor at day 9–12 and day 21–30 for Astodrimer Gel groups compared with placebo. Adverse events considered potentially treatment-related occurred in only 25% of Astodrimer Gel-treated patients vs. 22% of placebo patients.ConclusionAstodrimer Gel once daily for 7 days was superior to placebo for treatment of bacterial vaginosis and was well-tolerated. The 1% dose consistently showed the strongest efficacy across endpoints. These results support a role for Astodrimer Gel, 1%, as an effective treatment for bacterial vaginosis.
Highlights
Bacterial vaginosis (BV) is the most common vaginal infection worldwide and is approximately twice as common as vulvovaginal candidiasis [1]
Astodrimer has been shown to inhibit growth of bacteria associated with BV via a novel mechanism of action compared with conventional antibiotics, by blocking the attachment of bacteria to cells and inhibiting the formation of and disrupting biofilms
Astodrimer Gel once daily for 7 days was superior to placebo for treatment of BV, was well-tolerated, and provided rapid resolution of BV symptoms
Summary
Bacterial vaginosis (BV) is the most common vaginal infection worldwide and is approximately twice as common as vulvovaginal candidiasis [1]. Astodrimer is a generation-four lysine dendrimer with a polyanionic surface charge [10]. Both size and surface charge of the dendrimer contribute to the function of the compound [11]. Bacterial biofilms are important in the pathogenesis of BV and are not adequately targeted by existing therapies, leading to inadequate treatment and frequent recurrence [9] [12] [13] [14]. Astodrimer Gel contains a novel dendrimer intended to treat and prevent bacterial vaginosis. We assessed the efficacy and safety of Astodrimer Gel for treatment of bacterial vaginosis
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