Field study to investigate the effectiveness and safety of a novel orally administered combination drug product containing milbemycin oxime and lotilaner (Credelio® Plus) against natural intestinal nematode infections in dogs presented as veterinary patients in Europe

Abstract

Background A randomised, blinded, positive controlled, multicentre, Good Clinical Practice-compliant, pivotal field study was conducted to evaluate the effectiveness and safety of a new combination of lotilaner + milbemycin oxime tablets (Credelio® Plus; Elanco Animal Health) administered orally to client-owned dogs naturally infected with intestinal nematodes. Methods Client-owned dogs presenting to veterinary clinics from households in France, Hungary and Germany were screened for intestinal nematodes. Dogs with an initial positive faecal egg count that was subsequently confirmed with a follow-up faecal examination to demonstrate the presence of naturally occurring mixed or mono-infections with Toxocara canis, Toxascaris leonina, Trichuris vulpis or Ancylostoma caninum were enrolled on Day 0 into the study. Households were randomised in an approximately 2:1 ratio to receive either an investigational product (IP; Credelio Plus tablets) or control product (CP; Nexgard Spectra® tablets) as treatment. Dogs were administered the IP (n = 278) or CP (n = 117) once on Day 0 at a dose rate of 0.75–1.56 mg/kg bodyweight milbemycin oxime and 20.0–41.5 mg/kg bodyweight lotilaner (IP) or as recommended (CP). Effectiveness of the IP and CP treatments was based on the post-treatment reduction in geometric mean faecal egg counts on Day 8 (range Day 7–10) after treatment as compared to their pre-treatment nematode faecal egg counts. Results Geometric mean (GM) faecal egg counts for T. canis, A caninum and T. vulpis were reduced by ≥ 97.2% in the Credelio Plus group and by ≥ 95.3% in the afoxolaner + milbemycin oxime group. There were insufficient data to calculate a percentage reduction in GM faecal egg counts between Day 0 and Day 8 for T. leonina due to low prevalence. Credelio Plus was well tolerated in this field study. Of the 355 total doses administered, 82.3% were accepted free choice in the IP group compared to 80.8% in the CP group. Conclusions This study demonstrated effectiveness (≥ 97.2% reduction), safety and tablet acceptance of a combination of milbemycin oxime and lotilaner (Credelio Plus) administered orally to dogs with natural intestinal infections of T. canis, A. caninum and T. vulpis.

Preference in Dogs of Two Oral Endectoparasiticide Formulations: NexGard Spectra<sup>®</sup> (Afoxolaner and Milbemycin Oxime) and Credelio<sup>®</sup> Plus (Lotilaner and Milbemycin Oxime)

“…Preference tests are more sensitive than simple acceptance for the comparison of different formulations, but under field conditions, with a single offer, dogs could spontaneously accept a given formulation. As an example, in a recent field study, Credelio ® Plus was proposed to 355 dogs with 82.3% of these dogs taking the tablet without any difficulty (e.g., taken from an empty bowl or directly from the hand) and 17.7% of dogs needing to be pilled in the mouth [9]. We can hypothesize that the better the palatability will be, as demonstrated in preference study, the easier it will be for an owner to successfully offer a chewable, but it doesn't mean that the overall acceptance is not good.…”

“…In a recent palatability field study, Credelio ® Plus was administered to 355 dogs with 82.3% of these dogs taking the tablet without any difficulty (e.g. taking from an empty bowl or directly from the hand) and 17.7% of dogs needed it to be pilled in the mouth [9]. In the same study, NexGard Spectra ® was administered to 151 dogs, and 80.8% of these dogs took the chew spontaneously (no significant difference with Credelio ® Plus).…”

Credelio® Plus: a novel oral endectocide for dogs

“…Dog populations living under certain epizootiological scenarios are prone to harbouring more of the above-mentioned parasites at the same time. In fact, a field study described in this article collection proved that about 30% of dogs infected by intestinal nematodes may have fleas and/or ticks as well [ 4 ], and this high prevalence of mixed parasites has also been recorded in recent epizootiological surveys from Europe and overseas [ 26 – 28 ]. Thus, the availability of broad-spectrum palatable oral formulations like Credelio Plus is of utmost importance where major canine parasites live in sympatry and are simultaneously endemic.…”

“…The effectiveness studies confirmed the safety of Credelio Plus under both experimental and natural conditions. As outlined below, the pivotal studies that were conducted provided outstanding results against larval stages of key intestinal nematodes in controlled conditions [ 2 , 3 ] and for endo- and ectoparasites in field scenarios [ 4 – 6 ].…”

“…The high efficacy of Credelio Plus against adult intestinal nematodes was confirmed by a multi-centre field study conducted in several veterinary practices in three European countries. In particular, the product proved to be highly efficacious (≥ 97.2%) in reducing the faecal egg count in dogs naturally infected with T. canis , A. caninum and T. vulpis [ 4 ].…”