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Background  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.    Methods  In 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.    Results  Flea 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.    Conclusions  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.    Graphic Abstract

parasites and vectors

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 flea and tick infestations on dogs presented as veterinary patients in Europe