Efficacy and safety of a new spot-on formulation of selamectin plus sarolaner in the treatment of naturally occurring flea and tick infestations in cats presented as veterinary patients in Europe

Abstract

Two randomised, blinded, multi-centre field studies were conducted in Europe (Germany, Italy, France, Hungary) to demonstrate the efficacy and safety of three monthly applications of a new spot-on formulation of selamectin plus sarolaner (Stronghold Plus, Zoetis) against natural flea or tick infestations in cats presented as veterinary patients. The spot-on formulation was administered at the commercial dose range of 6.0-12.0mg selamectin and 1.0-2.0mg sarolaner per kg bodyweight. In the flea study, the improvement in clinical signs associated with flea allergy dermatitis (FAD) was also monitored. Imidacloprid plus moxidectin (Advocate for Cats, Bayer) and fipronil (Frontline Spot on, Merial) were used as positive control products in the flea and tick studies, 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 selamectin/sarolaner to the control products was assessed at each time-point using a non-inferiority margin of 15% at the one-sided 0.025 significance level. Cats were enrolled in a 2:1 ratio (selamectin/sarolaner:comparator). In the flea study, 277 cats were assessed for efficacy and safety, and an additional 170 cats were assessed for safety only. On days 14, 30, 60 and 90, efficacy against fleas was 97.4%, 97.3%, 98.8% and 99.4% in the selamectin/sarolaner-treated group and was 90.0%, 83.6%, 87.7% and 96.3% in the imidacloprid/moxidectin-treated group, respectively. Selamectin/sarolaner was non-inferior to imidacloprid/moxidectin at all time-points. For the 16 cats identified as having FAD at enrolment, clinical signs related to FAD improved following treatment administration. In the tick study, 200 cats were assessed for efficacy and safety, and a further 70 cats were assessed for safety only. Four tick species were identified. Overall efficacy against ticks was 96.7%, 92.6%, 98.8% and 99.5% in the selamectin/sarolaner-treated group and was 90.2%, 74.6%, 83.0% and 93.4% in the fipronil-treated group on Days 14, 30, 60 and 90, respectively. Selamectin/sarolaner was non-inferior to fipronil at all time-points, and was superior on Days 30 and 60. There were no serious treatment-related adverse events in any study. Thus, the new spot-on formulation of selamectin plus sarolaner administered at monthly intervals was safe and highly effective against natural infestations of fleas and ticks on cats, and improved clinical signs of FAD.

Comparative efficacy of a new spot-on combination product containing selamectin and sarolaner (Stronghold®Plus) versus fluralaner (Bravecto®) against induced infestations with Ixodes ricinus ticks on cats

“…The high and consistent efficacy of selemactin/sarolaner against I. ricinus [2, 7, 8] was confirmed in the present study. Three monthly treatments at the minimum recommended label dose of 1.0 mg sarolaner (and 6.0 mg/kg selamectin) resulted in a consistently high efficacy (> 95.8%) for at least 91 days.…”

Neue Arzneimittel für Kleintiere 2017

“…Nach der Anwendung von Stronghold® Plus traten an der Applikationsstelle leichter, vorübergehender Juckreiz, leichte bis mittelgradige Alopezie und Hautrötung auf (4,15). Des Weiteren kam es bei den Katzen zu Speicheln (4,15).…”

“…Nach der Anwendung von Stronghold® Plus traten an der Applikationsstelle leichter, vorübergehender Juckreiz, leichte bis mittelgradige Alopezie und Hautrötung auf (4,15). Des Weiteren kam es bei den Katzen zu Speicheln (4,15). Nach versehentlicher oraler Aufnahme wurden vorübergehende gastrointestinale Effekte wie Speichelfluss, Erbrechen, weicher Kot oder verminderte Nahrungsaufnahme beobachtet (4).…”

“…B. nichtsteroidale Antiphlogistika) konkurrieren. Allerdings wurden während der klinischen Feldversuche keine Wechselwirkungen von Stronghold® Plus mit anderen routinemäßig eingesetzten Tierarzneimitteln beobachtet (4,15).…”

Adherence to Veterinary Recommendations for Ectoparasiticides Purchased by Cat Owners in the United States.

“…3,10 Fleas and ticks also carry and transmit an assortment of vector-borne pathogens that can affect cats and people, including Bartonella spp., Ehrlichia spp., Rickettsia spp., Mycoplasma spp., as well as cestode, protozoal, and larial endoparasites. 1,2,4,13,14 Investigators have found that as many as 80% of eas collected from cat populations harbor feline or human pathogens of signi cance. 15 Safe and effective feline ea and tick treatment options are therefore an important component of the weeks after treatment.…”