Field study evaluating the efficacy of a combination formulation of fluralaner with moxidectin and pyrantel (BRAVECTOTriUNO) against canine intestinal nematode infections.

Abstract

BACKGROUND: There is a demand for broad-spectrum products effective against internal and external parasites to simplify dog-owner compliance with veterinary parasiticide treatment recommendations. A field study investigated the safety and efficacy of a broad-spectrum formulation of fluralaner, moxidectin, and pyrantel pamoate compared with a licensed afoxolaner-milbemycin oxime combination product in treating canine intestinal nematode infections in client-owned dogs at multiple sites in Europe. METHODS: Dogs with positive pre-treatment fecal egg counts (FEC) were randomized to treatment on day 0 with the investigative veterinary product (IVP), at dose rates of: IVP, fluralaner 10-20&#xa0;mg/kg, moxidectin 0.025-0.050&#xa0;mg/kg, pyrantel 5-10&#xa0;mg/kg (n&#x2009;=&#x2009;172); or a control product (CP), afoxolaner 2.5-5.2&#xa0;mg/kg, milbemycin oxime 0.5-1.0&#xa0;mg/kg (n&#x2009;=&#x2009;86). On day 14, FEC were completed on all study dogs. Efficacy against any intestinal nematode species was claimed if the FEC reduction in&#x2009;&#x2265;&#x2009;10 dogs initially positive for that species was&#x2009;&#x2265;&#x2009;90%, and if the geometric mean difference between pre- and post-treatment FEC was statistically significant (P&#x2009;&#x2264;&#x2009;0.05). RESULTS: Study dogs were enrolled at veterinary clinics in Albania (n&#x2009;=&#x2009;60), Bulgaria (n&#x2009;=&#x2009;111), Greece (n&#x2009;=&#x2009;27), and Italy (n&#x2009;=&#x2009;60). Where a sufficient number of infected dogs allowed for statistical comparison, geometric mean FEC reductions on day 14 versus day 0 in the IVP group were significant (P&#x2009;<&#x2009;0.0001) for hookworms, Toxocara canis, Toxascaris leonina, Trichuris vulpis, and capillarid-type eggs. On the basis of geometric mean reductions in FEC relative to day 0, the efficacy of the IVP exceeded 99% against all intestinal nematode parasites, and FEC reductions in the CP exceeded 98%. The percentage of nematode-free dogs in the IVP group was statistically noninferior (P&#x2009;<&#x2009;0.0001) to the CP group and even statistically superior at the &#x3b1;&#x2009;=&#x2009;0.025 level of significance (one-sided). There were no treatment-related adverse events. CONCLUSIONS: In client-owned dogs, the combination of fluralaner-moxidectin-pyrantel is safe and effective for the treatment of intestinal infections with hookworms, ascarids, including T.&#xa0;canis, and whipworms. On the basis of the complete elimination of parasite ova from the feces evaluated in this study, this fluralaner-moxidectin-pyrantel combination demonstrated to be significantly superior (P&#x2009;<&#x2009;0.025) to an afoxolaner-milbemycin combination in the treatment of canine intestinal nematode infections.