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Efficacy against nematode infections and safety of afoxolaner plus milbemycin oxime chewable tablets in domestic dogs under field conditions in Europe

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Abstract

Afoxolaner (AFX) plus milbemycin oxime (MO) combination chewable tablets (NexGard Spectra®, Merial) were evaluated for safety and efficacy against naturally acquired nematode infections in domestic dogs in a multi-centre, positive control, blinded field study using a randomized block design based on the order of presentation for allocation. In total, 408 dogs confirmed positive for naturally acquired infections of intestinal nematodes by pre-treatment faecal examination were studied in ten countries in Europe (Albania, Austria, Bulgaria, France, Germany, Hungary, Italy, Lithuania, Romania and Slovakia). Pre-treatment faecal examination revealed Toxocara, Toxascaris, hookworm, Trichuris and/or Capillaria nematode infections in 134, 30, 223, 155 and 14 dogs, respectively. Dogs were allocated to one of two treatment groups in a ratio of 1, AFX + MO chewables (≥2.5 mg AFX + ≥0.5 mg MO per kg body weight, according to dose bands; 207 dogs), and 1, MO plus praziquantel (PRZ) chewables (Milbemax®, Novartis; ≥0.5 mg MO + ≥5 mg PRZ per kg body weight, according to the manufacturer’s instructions; 201 dogs) and treated once. For evaluation of efficacy based on reduction of faecal nematode egg counts, two faecal samples, one collected prior to treatment and one collected 9 to 21 days after treatment, were examined using modified McMaster techniques. For evaluation of systemic safety, dogs were examined by a veterinarian before treatment administration and at study end, and dog owners observed the health status of their dogs until the end of the study and reported any abnormal observation. For dogs treated with AFX + MO chewables, the efficacy was 99.7, 99.7, 97.2, 99.7 and 99.7 % for Toxocara, Toxascaris, hookworm, Trichuris and Capillaria, respectively; and the efficacy was 99.5, 99.4, 94.3, 99.9 and 98.0 %, respectively, for the MO + PRZ-treated dogs (p ≤ 0.002 for all nematodes and both treatments). For Toxocara, hookworm and Trichuris, non-inferiority analysis demonstrated that the efficacy of AFX + MO chewable tablets was equal to or better than that of MO + PRZ. In spite that both treatments were ≥98 % efficacious against Toxascaris and Capillaria, a hypothesis of non-inferiority for both genera could not be established due to the low number of dogs infected with these parasites. No treatment-related adverse experiences were observed throughout the study. For both treatments, all dogs were given a systemic safety score of ‘excellent’ apart from one dog in each treatment group which received a score of ‘acceptable’. AFX + MO combination chewables were shown to be safe and demonstrated a high level of efficacy when administered once to dogs infected with a broad range of parasitic nematodes under field conditions.

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Acknowledgments

The authors would like to acknowledge the support of several veterinarians and technicians who contributed to the conduct of the study at the different sites including B. Hinney, P. Iliev, J. Klenner, R.P. Lia, R. Loibienė, A. Malakauskas, V. Messina, E. Napoli, M. Oltean, R. Postoli and K. Silbermayr.

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Authors and Affiliations

  1. Merial GmbH, Kathrinenhof Research Center, Walchenseestr. 8-12, 83101, Rohrdorf, Germany

    Steffen Rehbein, Martin Knaus, Doris Dollhofer, Katrin Kley & Martin Visser

  2. Merial S.A.S., Centre de Recherche de Saint-Vulbas, 1 allée des Cyprès, 01150, Saint-Vulbas, France

    Yasmina Mallouk, Wilfried Lebon & Philippe Jeannin

  3. Tierarztpraxis Breiltgens, Lärchenstr. 4, 82166, Gräfelfing, Germany

    Tatjana Breiltgens

  4. Dipartimento di Scienze Veterinarie, Università degli Studi di Messina, Polo Universitario dell’Annunziata, 98168, Messina, Italy

    Emanuele Brianti

  5. Kapriol Bt., Vároldal ut. 5, 8330, Sümeg, Hungary

    Balázs Capári

  6. Dipartimento di Sanità Pubblica e Zootecnia, Università degli Studi di Bari, Animali Facoltà di Medicina Veterinaria, Valenzano, Bari, 70010, Italy

    Filipe Dantas-Torres

  7. Centro de Pesquisas Aggeu Magalhães, Fundação Oswaldo Cruz, 50740465, Recife, Brazil

    Filipe Dantas-Torres

  8. Clinique Vétérinaire, Le Sialat les Hauts, 81100, Castres, France

    Michel Gau

  9. Institute of Parasitology, University of Veterinary Medicine, Veterinärplatz 1, 1210, Vienna, Austria

    Anja Joachim

  10. Tierarztpraxis Hofmann, Schulstr. 8, 38875, Elbingerode, Germany

    Karl-Heinz Kaulfuß

  11. Department of Parasitology, Faculty of Veterinary Medicine, Trakia University, Student Campus, 6000, Stara Zagora, Bulgaria

    Zvezdelina Kirkova

  12. Tierärztliche Klinik Nürnberg, Wertachstr. 1, 90451, Nürnberg, Germany

    Joerg Lechner

  13. Department of Parasitology and Parasitic Diseases, University of Agricultural Sciences and Veterinary Medicine, Calea Mănăştur 3-5, Cluj-Napoca, 400372, Romania

    Andrei D. Mihalca

  14. Ambulatorio Medico Veterinario “Peloro”, Via Consolare Pompea 2077 – Granatari, 98165, Messina, Italy

    Rosamaria Mirabito

  15. Department of Infectious Diseases, Lithuanian University of Health Sciences, Veterinary Academy, Tilzes str. 18, 47181, Kaunas, Lithuania

    Saulius Petkevičius

  16. Fakulteti i Mjekësisë Veterinare, Universiteti Bujqësor, Kodër, Kamëz, Tirana, Albania

    Dhimitër Rapti & Enstela Shukullari

  17. Clinique Vétérinaire des 3 Vallées, 44, avenue Pechiney, 09400, Tarascon sur Ariège, France

    Michel Sedeilhan

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  1. Steffen Rehbein
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Correspondence to Steffen Rehbein.

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NexGard® and NexGard Spectra® are trademarks of Merial; all other marks are the property of their respective owners. This document is provided for scientific purposes only. Any reference to a brand or trademark herein is for informational purposes only and is not intended for a commercial purpose or to dilute the rights of the respective owner(s) of the brand(s) or trademark(s).

Conflict of interest

The work reported herein was funded by Merial, Inc., GA, USA. All authors are current/were employees at the time of study conduct or were contractors of Merial.

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Rehbein, S., Knaus, M., Mallouk, Y. et al. Efficacy against nematode infections and safety of afoxolaner plus milbemycin oxime chewable tablets in domestic dogs under field conditions in Europe. Parasitol Res 116, 259–269 (2017). https://doi.org/10.1007/s00436-016-5287-8

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