Abstract
BackgroundThe novel isoxazoline molecule fluralaner provides 12 weeks activity against fleas and 8 to 12 weeks against tick infestations according to label claims.MethodsThis blinded, multi-center study in client-owned dogs evaluated the flea control provided by a single oral fluralaner treatment (25–56 mg/kg; Bravecto™, Merck Animal Health) compared to a control group administered three oral spinosad (30 – 60 mg/kg; Comfortis®, Elanco) treatments at 4-week intervals together with an amitraz collar (9%, Preventic®, Virbac). Households were randomized (3:1 ratio) to either fluralaner (224 dogs, 118 households) or control (70 dogs, 39 households). Within households, one primary dog with at least 10 live fleas at enrollment was randomly selected for whole body flea counts every 4 weeks through Week 12; all dogs were followed for safety until Week 12. Fluralaner dogs received two additional doses at Weeks 12 and 24 for further safety and palatability observations through Week 26.ResultsGeometric mean flea count reductions from baseline for the fluralaner group at Weeks 4, 8, and 12 were 99.7%, 99.8%, and 99.8%, respectively; and 96.1%, 99.5%, and 99.6% for the spinosad controls. Percentages of flea-free primary dogs at Weeks 4, 8, and 12 were 91.1%, 95.4%, and 95.3% for the fluralaner group; and 44.7%, 88.2%, and 84.4% for the controls; the differences were significant at Weeks 4 (P < 0.0001) and 12 (P = 0.0370). Improvements in veterinarian assessed flea allergy dermatitis (FAD) were observed in both groups. Fluralaner tablets were accepted free choice in over 90% of doses. The most common adverse event was vomiting, occurring in 7.1% of the fluralaner group and 14.3% of the controls. No treatment related serious adverse events were reported.ConclusionsA single treatment of dogs with the palatable fluralaner flavored chewable tablet provides a safe and effective option for 12 weeks of flea control at least equivalent to that of 3 sequential treatments with spinosad tablets. Linked to the high level of flea control was a substantial alleviation of associated signs of FAD.
Highlights
The novel isoxazoline molecule fluralaner provides 12 weeks activity against fleas and 8 to 12 weeks against tick infestations according to label claims
Two hundred and ninety-four (294) dogs from 157 households were enrolled between August 2011 and December 2011 at 18 study sites, with 118 primary dogs assigned to receive fluralaner and 39 primary dogs assigned to receive spinosad + amitraz
One third of dogs in each group were described as mixed breed, with the most common breed identifications being Chihuahua (6.7% [15/224] of fluralaner group dogs; 5.7% [4/70] of spinosad + amitraz dogs), Jack Russell (4.0% [9/224] and 4.3% [3/70]), Labrador retriever (4.0% [9/224] and 2.9% [2/70]) and Boxer (3.1% [7/224] and 4.3% [3/70])
Summary
This investigator-blinded, multicentric, positive-controlled study was undertaken to assess the flea control effectiveness of fluralaner tablets administered by owners to their flea-infested dogs. The flea treatment product assigned to each dog was dispensed by non-blinded trained clinic personnel who were instructed not to participate in collecting flea count data, physical examinations, or in the assessment of FAD. These personnel were responsible for any additional measures required to ensure blinding, such as removing the amitraz collar on enrolled control dogs before they were examined by blinded personnel. Blinding of any staff involved in study assessments was maintained by having a non-blinded individual (either the dog’s owner or a non-blinded member of clinic staff) remove the tick collar from control dogs prior to performance of flea counts, FAD assessment, or physical examination. Samples were submitted for clinical pathology assessments (CBC, chemistry screen, including liver and kidney panels, and urinalysis) for determination of any potential adverse treatment effects
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