Abstract

BackgroundA pivotal randomised, blinded, positive-controlled, multicentre, European field study was conducted to evaluate the effectiveness and safety of a novel combination tablet of lotilaner and milbemycin oxime (Credelio® Plus) administered orally to client-owned dogs naturally infested with fleas and/or ticks.MethodsIn this field study, households with flea- or tick-infested dog(s) were enrolled on Day 0 into the study to provide data for either the tick or flea infestation cohorts. Households were randomised in a 2:1 ratio to receive either the combination investigational product (IP, Credelio Plus® tablets) or the control product (CP: Nexgard Spectra® tablets). Dogs were administered IP (flea cohort n = 135; tick cohort: n = 147) or CP (flea cohort: n = 67; tick cohort: n = 74) once every 4 weeks for a total of three times at a dose rate of 20.0–41.5 mg/kg bodyweight lotilaner and 0.75–1.53 mg/kg bodyweight milbemycin oxime (IP) or as recommended (CP). Percentage reduction was calculated by comparing individual dog flea and tick counts at each assessed post-treatment time point to their respective baseline (pre-treatment) infestation. Resolution of the clinical signs of flea allergy dermatitis (FAD) was assessed in flea-allergic dogs on the days that flea counts were performed.ResultsFlea effectiveness of Credelio Plus® after 3 consecutive monthly treatments was 100% against Ctenocephalides felis, C. canis and Pulex irritans. Tick effectiveness of Credelio Plus® over the same time frame was 99.3% for Ixodes ricinus and 100% against Rhipicephalus sanguineus (s.l.). Flea effectiveness of the CP after three consecutive monthly treatments was 100% against C. felis, C. canis and P. irritans. Tick effectiveness of the CP over the same time frame was 99.8% for I. ricinus and 100% against R. sanguineus. Credelio Plus® was well tolerated based on the safety assessments in all treated dogs in this field study. Within both treatment groups there was a reduction in total FAD scores from baseline.ConclusionsThis pivotal European field study demonstrated the excellent effectiveness and safety of a combination of lotilaner and milbemycin oxime (Credelio Plus®) administered orally to dogs naturally infested with fleas and/or ticks.Graphical

Highlights

  • A pivotal randomised, blinded, positive-controlled, multicentre, European field study was conducted to evaluate the effectiveness and safety of a novel combination tablet of lotilaner and milbemycin oxime (­Credelio® Plus) administered orally to client-owned dogs naturally infested with fleas and/or ticks

  • Forster et al Parasites Vectors (2021) 14:299. This pivotal European field study demonstrated the excellent effectiveness and safety of a combination of lotilaner and milbemycin oxime (Credelio ­Plus®) administered orally to dogs naturally infested with fleas and/or ticks

  • These 429 primary dogs were randomised to investigational product (IP) or control product (CP) groups, with 423 dogs (Table 1) included in this population for analysis since 6 enrolled dogs were excluded from the flea and tick effectiveness populations

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Summary

Introduction

A pivotal randomised, blinded, positive-controlled, multicentre, European field study was conducted to evaluate the effectiveness and safety of a novel combination tablet of lotilaner and milbemycin oxime (­Credelio® Plus) administered orally to client-owned dogs naturally infested with fleas and/or ticks. Blood-feeding by C. felis and C. canis can cause local irritation known as flea bite dermatitis and with repeated exposure dogs may develop flea allergy dermatitis (FAD) [2, 3]. Fleas are known to transmit several zoonotic disease agents such as flea-borne spotted fever (Rickettsia felis), murine typhus (Rickettsia typhi) and cat scratch disease (Bartonella henselae) [4, 5]. Ticks are found throughout most of Europe and on dogs predominantly include species from the genera Dermacentor, Ixodes and Rhipicephalus [1]. In Europe tick-transmitted disease agents, some of which are zoonotic, include Babesia canis vectored by Dermacentor reticulatus, canine and human anaplasmosis (Anaplasma phagocytophilum) and Lyme borreliosis (Borrelia burgdorferi (s.l.)), both of which are transmitted by Ixodes ricinus [5]. Ticks in the genus Rhipicephalus are known to transmit canine ehrlichiosis (Ehrlichia canis), babesiosis (Babesia vogeli, Babesia gibsoni), hepatozoonosis (Hepatozoon canis) and Mediterranean spotted fever (Rickettsia conorii) [8]

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