title: Field evaluation of the efficacy and safety of a combination of spinosad and milbemycin oxime in the treatment and prevention of naturally acquired flea infestations and treatment of intestinal nematode infections in dogs in Europe.
abstract: Two separate randomised, blinded, multicentre field trials were conducted to evaluate the efficacy and safety of a combination of spinosad and milbemycin oxime (MO) (Trifexis(®), Elanco Animal Health) in the treatment and prevention of naturally acquired flea infestations and intestinal nematode infections in European dogs. Treatments using Trifexis(®) and each control veterinary product (CVP) were administered once on Day 0 in both field studies. In the flea field trial, 11 veterinary clinics in France participated in the study. On Day 0, whole body flea comb counts were conducted on all dogs being evaluated for enrolment. Dogs with ≥7 fleas on Day 0 were enrolled, treated once on Day 0 with spinosad/MO or the CVP (Stronghold(®); selamectin) and then underwent post-treatment flea counts on Days 14 and 30. There were 150 spinosad/MO treated dogs and 71 CVP treated dogs included in the flea effectiveness population. Effectiveness against fleas (% reduction in geometric means; GM) was 98.97% and 97.37% for the spinosad/MO treated dogs, and 97.43% and 93.96% for the CVP dogs on Days 14 and 30, respectively, compared to the pre-treatment baseline flea counts. Of the spinosad/MO dogs, 89.3% and 80.0% had no live fleas on Days 14 and 30, compared to 77.5% and 70.4% of the CVP dogs, respectively. In the nematode field trial, data from 10 veterinary clinics in France and 19 in Ireland were pooled. Faecal samples from dogs at each clinic were analysed. A positive result at screening (parasite eggs from Toxocara canis, Toxascaris leonina, Trichuris vulpis or Ancylostoma caninum) allowed for enrolment. Dogs were randomised to spinosad/MO or the CVP (Milbemax(®); MO/praziquantel). On Day 8, a post-treatment faecal sample was taken and analysed. Of 2333 dogs screened for nematode eggs, 238 dogs were positive with one or more of these nematodes, and 229 were enrolled in the study. Of the 229 dogs, 151 were treated with a single dose of spinosad/MO, and 77 were treated with a single dose of CVP. Post-treatment effectiveness against all nematodes (% reduction GM) was achieved with reductions of 98.57% and 97.57% for the spinosad/MO treated dogs and CVP dogs, respectively, as compared to the pre-treatment baseline faecal egg counts. Trifexis(®) was shown to be safe and effective against natural infestations of fleas as well as mixed and single intestinal nematode infections in client owned dogs in Europe when administered as a single oral administration at the recommended dose.
authors.affiliation: Elanco Animal Health, Eli Lilly and Company Limited, Basingstoke, Hampshire, United Kingdom.
authors.forename: Brad
authors.initials: B
authors.lastname: Hayes
authors.affiliation: Elanco Animal Health, Eli Lilly and Company Limited, Basingstoke, Hampshire, United Kingdom.
authors.forename: Beate
authors.initials: B
authors.lastname: Schnitzler
authors.affiliation: Elanco Animal Health, Eli Lilly and Company Limited, Basingstoke, Hampshire, United Kingdom.
authors.forename: Scott
authors.initials: S
authors.lastname: Wiseman
authors.affiliation: Elanco Animal Health Research and Development, a Division of Eli Lilly and Company, 2500 Innovation Way, Greenfield, IN, USA. Electronic address: snyder_daniel_e@elanco.com.
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Snyder
mesh_terms: D000284:Administration, Oral; D000818:Animals; D000871:Anthelmintics / Q000494:pharmacology / Q000627:therapeutic use*; D058251:Ctenocephalides / Q000187:drug effects; D004283:Dog Diseases / Q000188:drug therapy* / Q000469:parasitology / Q000517:prevention & control; D004285:Dogs; D004338:Drug Combinations; D004359:Drug Therapy, Combination / Q000662:veterinary; D005060:Europe / Q000453:epidemiology; D005243:Feces / Q000469:parasitology; D005260:Female; D058267:Flea Infestations / Q000188:drug therapy / Q000517:prevention & control / Q000662:veterinary*; D007306:Insecticides / Q000494:pharmacology / Q000627:therapeutic use; D007559:Ivermectin / Q000031:analogs & derivatives / Q000494:pharmacology; D018942:Macrolides / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D009348:Nematoda / Q000502:physiology; D009349:Nematode Infections / Q000188:drug therapy / Q000517:prevention & control / Q000662:veterinary*; D010270:Parasite Egg Count / Q000662:veterinary; D011223:Praziquantel / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000871:Anthelmintics; D004338:Drug Combinations; D007306:Insecticides; D018942:Macrolides; C078973:milbemycin oxime; D011223:Praziquantel; D007559:Ivermectin; C414354:selamectin; C415329:spinosad
keywords: Chemoprophylaxis; Clinical trial; Dog; Milbemycin oxime; Spinosad; Zoonotic