Efficacy and safety of a novel oral isoxazoline, sarolaner (Simparica (TM)) in the treatment of naturally occurring flea and tick infestations in dogs presented as veterinary patients in Europe

摘要

Two randomised, blinded, multi-centered field studies were conducted in Europe to demonstrate the efficacy and safety of three monthly oral doses of sarolaner (Simparica (TM), Zoetis) administered at a minimum dosage of 2.0 mg/kg (range 2-4 mg/kg) against natural flea or tick infestation of dogs presented as veterinary patients. In the flea study, the improvement in clinical signs associated with flea allergy dermatitis (FAD) was also investigated. The palatability of the sarolaner chewable tablet formulation was evaluated in both studies. Spinosad (Comfortis (R) Chewable Tablets, Elanco) and fipronil (Frontline (R) Spot on, Merial) were used as positive controls in the flea and tick study, respectively. Treatments were administered on Days 0, 30 and 60. Efficacy was calculated based on the mean percent reduction of live parasite counts on post-treatment days 14, 30, 60 and 90 versus the pre-treatment count on Day 0. Non-inferiority of sarolaner to the control products was assessed at each time-point using a margin of 15% at the one-sided 0.025 significance level.