A randomized, blinded, controlled USA field study to assess the use of fluralaner tablets in controlling canine flea infestations

Particle and Fibre Toxicology

Fangshi Sun¹  Frank Guerino¹  Cheyney Meadows¹ 

[1] Merck Animal Health, Summit, NJ, USA

关键词: Field study;    Safety;    Efficacy;    Spinosad;    Fleas;    Fluralaner;   

Others  :  1181861
DOI  :  10.1186/1756-3305-7-375

 received in 2014-05-15, accepted in 2014-08-04,  发布年份 2014

【 摘 要 】

Background

The novel isoxazoline molecule fluralaner provides 12 weeks activity against fleas and 8 to 12 weeks against tick infestations according to label claims.

Methods

This 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.

Results

Geometric 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.

Conclusions

A 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.

【 授权许可】

   
2014 Meadows et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Dryden MW, Payne PA, Smith V, Hostetler J: Evaluation of an imidacloprid (8.8% w/w)–permethrin (44.0% w/w) topical spot-on and a fipronil (9.8% w/w)–(S)-methoprene (8.8% w/w) topical spot-on to repel, prevent attachment, and kill adult Ixodes scapularis and Amblyomma americanum ticks on dogs. Vet Ther 2006, 7:173-186.
• [2]Rust MK: Advances in the control of Ctenocephalides felis (cat flea) on cats and dogs. Trends Parasitol 2005, 21:232-236.
• [3]Dryden MW, Ryan WG, Bell M, Rumschlag AJ, Young LM, Snyder DE: Assessment of owner-administered monthly treatments with oral spinosad or topical spot-on fipronil/(S)-methoprene in controlling fleas and associated pruritus in dogs. Vet Parasitol 2013, 191:340-346.
• [4]Snyder DE, Meyer J, Zimmermann AG, Qiao M, Gissendanner SJ, Cruthers LR, Slone RL, Young DR: Preliminary studies on the effectiveness of the novel pulicide, spinosad, for the treatment and control of fleas on dogs. Vet Parasitol 2007, 150:345-351.
• [5]Rohdich R, Roepke RKA, Zschiesche E: A randomized, blinded, controlled and multi-centered field study comparing the efficacy and safety of Bravecto (fluralaner) against Frontline (fipronil) in flea- and tick-infested dogs. Parasit Vectors 2014, 7:83. BioMed Central Full Text
• [6]Walther FM, Allan MJ, Roepke RKA, Nuernberger MC: The effect of food on the pharmacokinetics of oral fluralaner in dogs. Parasit Vectors 2014, 7:84. BioMed Central Full Text
• [7]NADA 141–126 Bravecto Fluralaner Chewable Tablets Dogs [http://www.fda.gov/downloads/animalveterinary/products/approvedanimaldrugproducts/foiadrugsummaries/ucm399075.pdf webcite]
• [8]Walther FM, Allan MJ, Roepke RKA, Nuernberger MC: Safety of fluralaner chewable tablets (Bravecto), a novel systemic antiparasitic drug, in dogs after oral administration. Parasit Vectors 2014, 7:87. BioMed Central Full Text
• [9]Walther FM, Paul AJ, Allan MJ, Roepke RKA, Nuernberger MC: Safety of fluralaner, a novel systemic antiparasitic drug, in MDR1(-/-) Collies after oral administration. Parasit Vectors 2014, 7:86. BioMed Central Full Text
• [10]Medleau L, Clekis T, McArthur TR, Alva R, Barrick RA, Jeannin P, Irwin J: Evaluation of fipronil spot-on in the treatment of flea allergic dermatitis in dogs. J Small Anim Pract 2003, 44:71-75.
• [11]Bonneau S, Skowronski V, Sanquer A, Maynard L, Eun HM: Therapeutic efficacy of topical hydrocortisone aceponate in experimental flea-allergy dermatitis in dogs. Aust Vet J 2009, 87:287-291.
• [12]Robertson-Plouch C, Baker KA, Hozak RR, Zimmermann AG, Parks SC, Herr C, Hart LM, Jay J, Hutchens DE, Snyder DE: Clinical field study of the safety and efficacy of spinosad chewable tablets for controlling fleas on dogs. Vet Ther 2008, 9:26-36.
• [13]Estrada-Peña A, Ascher F: Comparison of an amitraz-impregnated collar with topical administration of fipronil for prevention of experimental and natural infestations by the brown dog tick (Rhipicephalus sanguineus). J Am Vet Med Assoc 1999, 214:1799-1803.
• [14]Plue RE, Jernigan AD, Acre KE, Coleman MW, Currin ST, Ellis AJ, Lange RL, Lange RL, Weiner DR: Field efficacy, safety and acceptability of ivermectin plus pyrantel in growing and adult dogs. In Proceedings of the Heartworm Symposium ’92. Edited by Soll MD. Batavia, IL: American Heartworm Society; 1992:205-208.
• [15]Seward RL, Brokken ES, Plue RE: Ivermectin vs heartworm – a status update. In Proceedings of the Heartworm Symposium ’86. Edited by Otto GF. Washington, DC: American Heartworm Society; 1986:1-8.