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Toxocara Canis, Uncinaria Stenocephala and Ancylostoma Caninum in Dogs

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Toxocara Canis, Uncinaria Stenocephala and Ancylostoma Caninum in Dogs Parasitol Res (2011) 109:S1 – S8 DOI 10.1007/s00436-011-2397-1 Procox® Efficacy of Emodepside plus Toltrazuril (Procox® Oral Suspension for Dogs) against Toxocara canis, Uncinaria stenocephala and Ancylostoma caninum in Dogs Annette Schimmel1, Iris Schroeder1, Gertraut Altreuther1 (*), Terry Settje2, Samuel Charles2, Sonja Wolken3, Dawid J. Kok4, Jennifer Ketzis5, David Young6, Douglas Hutchens1, Klemens J. Krieger1 1 Bayer Animal Health GmbH, Leverkusen, Germany 2 Bayer HealthCare LLC, Shawnee Mission, KS, USA 3 Institute for Parasitology, University of Veterinary Medicine Hannover, Hannover, Germany 4 ClinVet International (Pty) Ltd., Bloemfontein, Republic of South Africa 5 Charles River Laboratories Preclinical Services Ireland, Co. Mayo, Ireland 6 Young Veterinary Research Services, Turlock, CA, USA * E-mail: [email protected] Abstract The efficacy of emodepside plus toltrazuril (Pro- and between 4 and 655 worms for hookworms. The cox® oral suspension for dogs) against different studies demonstrated 100 % efficacy of emodepside/ species of gastrointestinal nematodes (Toxocara toltrazuril suspension against mature adult, ≥ 94.7 % canis, Ancylostoma caninum, Uncinaria steno- efficacy against immature adult and 99.3 % efficacy cephala) was evaluated in nine randomised, against the L4 larval stage of T. canis. The efficacy blinded and placebo-controlled laboratory studies against mature adult A. caninum was ≥ 99.5 % and in naturally or experimentally infected dogs. The the efficacy against mature adult U. stenocephala product was used at the proposed minimum dose was 100 %. All differences between treatment and of 0.45 mg emodepside and 9 mg toltrazuril per control groups were statistically significant and no kg body weight. Efficacy was calculated based on gender effect was found. It can be concluded that the worm counts after necropsy. emodepside/toltrazuril suspension represents a safe Worm burdens in the control dogs ranged between and highly effective product in dogs with nematode 0 and 409 worms of the respective stage for T. canis (T. canis, hookworms) infection. S1 Procox® Introduction including the route of infection (oral or prenatal), infection dose, age and immune status of the dog so Nematodes in dogs are an important group of endo- that prepatency can be as short as ~ 3 weeks after a parasites in which Toxocara canis and hookworms prenatal infection and up to ~ 6 weeks after an oral are of special interest (Epe et al. 2004; Pullola infection (Parsons 1987). The lactogenic transmission et al. 2006). The prevalence described in studies is of lesser importance for the infection of dogs with performed in many parts of the world varies con- T. canis (Burke and Roberson 1985a,b). siderably. Toxocara canis is the most frequently Infections with Uncinaria stenocephala mainly encountered, with prevalence in Europe often take place by the oral route, while infections with ranging up to 32 % (Fok et al. 2001; Sager et al. Ancylostoma caninum can be caused orally as well 2006; Grandemange et al. 2007; Wright and Wolfe as percutaneously. The prepatent period has been 2007; Nikolic et al. 2008). Ancylostomatidae, as the reported to be ~ 2 – 3 weeks. However, the time second most common nematodes, are found up to taken to develop to maturity depends also on a 13.1 % with an even higher prevalence rate of up variety of factors including host immunity and the to 32 % in stray, shelter and kennel dogs (Fok et al. route of infection (Bowman et al. 2010). 2001; Pullola et al. 2006; Grandemange et al. 2007; Emodepside/toltrazuril suspension is a new combi- Martinez-Carrasco et al. 2007). Generally, it has nation of two already known actives in veterinary to be considered that cited prevalence cannot be medicine. Emodepside is a semi-synthetic derivate compared directly as the examined populations are of PF1022A and belongs to the cyclic depsipeptides. quite different to each other (Schnieder et al. 2011). Emodepside binds to a presynaptic latrophilin recep- Additionally, Wolfe et al. (2001) found in foxes that tor which belongs to the group of the G-protein-cou- the faecal flotation method underestimated the true pled receptors (Willson et al. 2003; Harder et al. 2005). prevalence of T. canis by 46.7 % and of Uncinaria In addition, emodepside acts via a second target, a species by 31 %, so the true prevalence in the dog Ca++-activated K+ channel. This channel belongs to populations studied may actually be much higher. the large conductance calcium- and voltage-activated Many publications on parasite prevalence present potassium channels, termed SLO-1, which generally details on age groups, and generally, prevalence of are important regulators of cell excitability. The end Toxocara canis is considerably higher in puppies effect of emodepside is flaccid paralysis and death of and young dogs compared to older dogs (Wright and the nematode (Holden-Dye et al. 2007). Wolfe 2007; Fok et al. 2001; Pullola et al. 2006; Mar- Toltrazuril has been used in veterinary medicine tinez-Carrasco et al. 2007; Ugbomoiko et al. 2008). since the 1980s. It has broad-spectrum activity This matches with prenatal transmission being the against species of various genera of coccidia (Eime- most important way of T. canis infection in dogs. ria, Isospora, Toxoplasma, Sarcocystis etc.) in a Parenteral infections of puppies occur not only after wide range of livestock and companion animals. the infection of the pregnant bitch but also through The combination of these two actives, emodepside reactivation of somatic tissue larvae from earlier and toltrazuril (Procox® suspension) is indicated infections (Webster 1958; Koutz et al. 1966). The for dogs, including puppies from 2 weeks of age developmental cycle of T. canis is complex and can and young dogs, when mixed parasitic infections involve migration of larval stages through various caused by roundworms and coccidia of the following organs including the lungs, liver and kidneys before species are suspected or demonstrated: Toxocara reaching the small intestine where development to canis (mature adult, immature adult, L4), Unci- the adult stage is completed or enters a hypobiotic naria stenocephala (mature adult), Ancylostoma stage, e.g. in muscle tissue. The different pathways caninum (mature adult), Isospora ohioensis-com- and times for development depend on multiple factors plex and Isospora canis. S2 Procox® Emodepside has already been proven to be effec- were housed together. At least on the day of treat- tive against nematodes in dogs applied as emodep- ment and the following two days, the dogs were side plus praziquantel in a tablet formulation, housed individually. Commercial dog food was pro- Profender® tablets, Bayer Animal Health GmbH, vided once or twice per day and water was available Leverkusen, Germany (Altreuther et al. 2009a,b; ad libitum. All dogs were acclimatised for at least Schimmel et al. 2009). The present paper focuses 7 days prior to the start of the study. on the nematocidal efficacy of emodepside/toltra- General requirements for study inclusion were zuril suspension and nine controlled laboratory good health and no recent anthelmintic use. Dogs studies against mature and immature stages of included in the six studies that used experimen- T. canis and mature hookworms in naturally and tal infections were required to be negative for experimentally infected dogs are described. nematodes before infection as examined by fae- cal egg counts during acclimation (no. 1, 3 – 6, 9). Dogs included in studies that investigated effica- Materials and methods cy against patent infections (no. 1, 2, 6 – 9) were required to demonstrate at least 2 positive faecal The efficacy of emodepside/toltrazuril suspension egg counts before treatment. (Procox®) against different species of gastrointestinal nematodes (Toxocara canis, Ancylostoma caninum, Clinical observations Uncinaria stenocephala) and developmental stages of In all studies, dogs were physically examined at T. canis was investigated in nine laboratory studies. least once during acclimation and once before treat- The study designs are summarised in Tab. 1. ment. Additionally, all dogs were observed for their All studies were conducted in accordance with general health once daily except for treatment days VICH guideline 9 “Good Clinical Practice” (July and the two following days, when clinical assess- 2000) and followed the recommendations given in ments were conducted instead. On treatment days the VICH guidelines 7 “Efficacy requirements for clinical assessments were conducted once pre treat- anthelmintics: overall guidelines” (December 2000) ment and ~ 0.5, 1, 2, 3, 4 and 8 hours post treat- and 19 “Efficacy of anthelmintics: specific recom- ment. Clinical assessments were continued twice mendations for canines” (July 2001) as well as the daily for the following two days. WAAVP guideline for evaluating the efficacy of anthelmintics for dogs and cats (Jacobs et al. 1994). Infection Three studies (no. 2, 7, 8) were conducted with nat- Study animals urally infected dogs in the USA and the Republic of The dogs used in the studies were either purpose- South Africa. In the other studies, dogs were orally bred individuals from different suppliers, animals infected with embryonated T. canis eggs or hook- owned by the contract research organisations worm larvae. The origin of the isolates and doses (CRO) or animals obtained from commercial ken- used for infection are shown in Tab. 1. nels according to the respective local regulations. In total 143 healthy Beagle or crossbred dogs (6 weeks Treatment to adult, 67 male, 76 females) weighing between Dogs were randomised by sex and body weight and 0.8 and 16.6 kg were enrolled. The dogs were either allocated to either treatment (71 dogs) or control identified by ear tattoo, numbered collar tags or (72 dogs) group and treated once with emodepside/ subcutaneously implanted microchip and were toltrazuril or placebo suspension. In the six studies housed single or in groups. After randomisation, investigating efficacy against mature adult stag- it was ensured that only dogs of the same group es, animals were treated after patency had been S3 Procox® demonstrated.
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