Efficacy and safety of sarolaner in the treatment of canine ear mite infestation caused by Otodectes cynotis: a non-inferiority study.

BACKGROUND: Various treatments are available for ear mite infestations in dogs. OBJECTIVE: The efficacy of sarolaner was evaluated against ear mite infestation caused by Otodectes cynotis in dogs and compared with topical moxidectin/imidacloprid in a single-masked, multi-centre field study. ANIMALS: Client-owned dogs with O. cynotis infestation were treated monthly with oral sarolaner (n = 163) or topical moxidectin/imidacloprid (n = 78). METHODS: The presence of mites in the ear canals and the clinical signs associated with otoacariasis (including head shaking, pruritus/ear scratching, trauma or alopecia of the pinnae, and erythema, ulceration and debris in the ear canals) was evaluated on days 0, 14 and 30, and, if applicable, on day 60. Dogs were considered cured of mite infestation following one (on day 0) or two (on days 0 and 30) monthly treatments, if no live mites were found in either ear. Non-inferiority was evaluated at days 14 and 30. RESULTS: Parasitological cure was achieved in 76.4%, 90.5% and 93.3% of the sarolaner-treated and in 53.9%, 63.5% and 66.7% of the moxidectin/imidacloprid-treated dogs on days 14, 30 and 60, respectively. At study completion, on day 60 at the latest, parasitological cure was achieved overall in 99.4% of sarolaner-treated and 87.8% of moxidectin/imidacloprid-treated cases. The parasitological cure rate for sarolaner was non-inferior to moxidectin/imidacloprid at days 14 and 30. The clinical signs of otoacariasis improved throughout the study in both groups. There were no treatment-related adverse events. CONCLUSIONS: A single oral administration of sarolaner was safe and highly effective in the treatment of O. cynotis infestation in dogs.

Efficacy and safety of sarolaner against generalized demodicosis in dogs in European countries: a non-inferiority study.

BACKGROUND: Treatment of canine demodicosis can be challenging; new treatments are always being sought. OBJECTIVE: The efficacy of sarolaner was evaluated in comparison with a moxidectin/imidacloprid topical product against generalized demodicosis in dogs in a randomized, single-masked, multi-centre field study. ANIMALS: Client-owned dogs were treated monthly with oral sarolaner (n = 53) or with weekly/monthly topical moxidectin/imidacloprid (n = 28). METHODS: Mites were counted monthly in deep skin scrapings and the severity of skin lesions was evaluated. Dogs completed the study when no live mites were found on two consecutive monthly skin scrapings or on day 180 at the latest (study end). RESULTS: Parasitological cure, defined as the first time that no live mites were found in the skin scrapings, was achieved in 92.9% and 100% of the dogs after three and no more than five monthly treatments with sarolaner (respectively). In the moxidectin/imidacloprid group, 77.3% and 91.7% of the dogs were cured after three and six months, respectively. Parasitological cure rate for sarolaner was non-inferior to moxidectin/imidacloprid on day 60. Mite counts were reduced by 77.2%, 95.0%, 98.5%, 99.0%, 100% and 100% in the sarolaner group and by 68.0%, 88.4%, 91.1%, 92.7%, 73.9% and 82.2% in the moxidectin/imidacloprid group, on days 30, 60, 90, 120, 150 and 180, respectively, compared to pre-treatment counts. The skin lesions improved throughout the study; the total affected body surface decreased by 94% in the sarolaner and by 72% in the moxidectin/imidacloprid group. There were no treatment-related adverse events. CONCLUSIONS: Monthly oral administration of sarolaner was safe and highly effective in the treatment of generalized demodicosis in dogs.

Comparative speed of kill of oral treatments with Simparica™ (sarolaner) and Bravecto®(fluralaner) against induced infestations of Rhipicephalus sanguineus on dogs.

BACKGROUND: Rhipicephalus sanguineus is the most widely distributed tick species infesting dogs worldwide, which may cause discomfort to the host and transmit diseases. Acaricides with a rapid and sustained speed of kill are thus important to prevent infestation and to reduce the risk of disease transmission. In this study, the speed of kill of a monthly administered Simparica™ (sarolaner) treatment against induced infestations with R. sanguineus on dogs was evaluated and compared with a single dose of Bravecto®(fluralaner) for 95 days after the initial treatment. METHODS: Twenty four dogs were randomly allocated to treatment and were treated with either placebo or sarolaner (at 2 to 4 mg/kg) on Days 0, 30 and 60 or with fluralaner (at 25 to 56 mg/kg) once on Day 0. Tick counts were performed in situ 8 and 12 h and with removal of the ticks 24 h after treatment and subsequent re-infestations on Days 14, 28, 44, 56, 74, 90 and 95. Acaricidal efficacy was determined at each time point relative to the placebo group. RESULTS: Both products significantly reduced live ticks within 8 h after treatment against an existing infestation with R. sanguineus, and killed all ticks on all dogs within 24 h. After re-infestation, sarolaner provided ≥98.5 % reduction within 24 h on all days except Days 74 and 95 (P < 0.0001), compared to fluralaner which provided ≥95.5 % reduction until Day 44. Geometric mean live tick counts for sarolaner were significantly lower (P ≤ 0.0415) at 24 h than those for fluralaner on all days, except on Days 0, 14 and 28 (P ≥ 0.0678). There were no treatment-related adverse reactions observed during the study. CONCLUSIONS: When dosed at monthly intervals for 3 consecutive months, Simparica™ has a faster and more consistent speed of kill against R. sanguineus than a single oral dose of Bravecto® for which efficacy decreased after Day 44.

Comparative speed of kill after treatment with Simparica™ (sarolaner) and Advantix®(imidacloprid + permethrin) against induced infestations of Dermacentor reticulatus on dogs.

BACKGROUND: Ticks are common ectoparasites that infest dogs globally. Acaricides with rapid and sustained speed of kill are critical to control infestations and to reduce the risk of disease transmission. This study evaluated the speed of kill for 5 weeks after a single dose of orally administered Simparica™ (sarolaner) against induced infestations with Dermacentor reticulatus on dogs, compared to Advantix® Spot-on solution for dogs (imidacloprid + permethrin). METHODS: Twenty four dogs were randomly allocated to treatment with either a placebo tablet, a sarolaner tablet (at 2 to 4 mg/kg) or with Advantix® as per label instructions. Dogs were treated on Day 0 and tick counts were performed in situ at 8 and 12 hours and with removal of the ticks at 24 hours after treatment and subsequent re-infestations on Days 7, 14, 21, 28 and 35. Acaricidal efficacy was determined at each time point relative to live tick counts from the placebo-treated dogs. RESULTS: Based on arithmetic (geometric) mean tick counts, the efficacy of sarolaner was ≥75.6 % (89.6 %) within 8 hours of treatment and tick counts were significantly lower than placebo and imidacloprid + permethrin-treated dogs (P < 0.0001), while imidacloprid + permethrin had no significant reduction (P ≥ 0.3990) at 8 or 12 hours after treatment. Sarolaner killed all ticks on the dogs within 24 hours after treatment, while imidacloprid + permethrin efficacy was only 48.1 %. After weekly re-infestations sarolaner significantly reduced the tick counts versus placebo within 8 hours on Days 7, 14 and 35 (P ≤ 0.0239), and at 12 hours and 24 hours (P ≤ 0.0079) until Day 35.Sarolaner efficacy was ≥95.8 % within 24 hours for 35 days. Significantly more live ticks (P ≤ 0.0451) were recovered from imidacloprid + permethrin-treated dogs than from sarolaner-treated dogs at 24 hours after infestation on all days. There were no sarolaner-related adverse reactions during the study. CONCLUSIONS: This study demonstrated that Simparica™ had a faster and more consistent speed of kill against D. reticulatus compared to Advantix®. The rapid and consistent efficacy within 24 hours for 5 weeks after a single oral dose of Simparica™ provides effective and reliable control of D. reticulatus and reduces the risk of transmission of tick-borne diseases.