scholarly journals 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

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Sophie Forster ◽  
Scott Wiseman ◽  
Daniel E. Snyder
Keyword(s):  
Field Study ◽  
Treatment Time ◽  
Drug Product ◽  
Clinical Signs ◽  
Rhipicephalus Sanguineus ◽  
Time Frame ◽  
Combination Drug ◽  
Combination Tablet ◽  
Milbemycin Oxime ◽  
Pulex Irritans

Abstract 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

scholarly journals Effectiveness of a novel orally administered combination drug product containing milbemycin oxime and lotilaner (Credelio® Plus) for the treatment of larval and immature adult stages of Ancylostoma caninum in experimentally infected dogs

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Daniel E. Snyder ◽  
Scott Wiseman ◽  
Elizabeth Crawley ◽  
Kim Wallace ◽  
Dwight D. Bowman ◽  
...  
Keyword(s):  
Drug Product ◽  
Geometric Mean ◽  
Time Frame ◽  
Immature Stage ◽  
Combination Drug ◽  
Ancylostoma Caninum ◽  
Combination Tablet ◽  
Milbemycin Oxime ◽  
Infective Larvae ◽  
Intestinal Nematode

Abstract Background The hookworm, Ancylostoma caninum, is a common and important zoonotic intestinal nematode parasite that infects dogs globally. Both the immature and adult stages of A. caninum ingest large volumes of blood during the feeding process and can cause severe anemia and death in young dogs, even before patent infections can be diagnosed using routine faecal examination methods. Thus, effective treatment of any pre-patent stages of immature hookworms can reduce or eliminate the risk of clinical disease in infected dogs and additionally reduce environmental contamination of eggs and infective larvae. Two randomized, blinded, GCP-compliant, pivotal laboratory dose confirmation studies were conducted to evaluate the effectiveness and safety of a new novel combination of lotilaner and milbemycin oxime tablets (Credelio Plus®) administered orally to dogs experimentally infected with immature (L4 and immature adult [L5]) stages of A. caninum. Methods Treatments using the intended global commercial tablet formulation of Credelio Plus were administered in a time frame relative to inoculation with infective larvae so that effectiveness could be assessed against each specific immature stage of A. caninum. In each study, dogs were randomized to one of six (study 1) or four (study 2) treatment groups. Each treatment group contained 8 (study 1) or 10 (study 2) dogs that had been experimentally inoculated with infective A. caninum larvae on day 0 and were dosed once on day 7 or day 11. Enrolled subjects were administered placebo tablets, Credelio Plus tablets, or lotilaner mono tablets to provide minimum dosages of 0.75 mg/kg of milbemycin oxime and 20 mg/kg of lotilaner. All dogs were necropsied 5 days after their respective treatment. All nematodes recovered from the gastrointestinal tract at necropsy were counted by species and stage. Results For both dose confirmation studies and based on geometric mean worm counts, efficacy of Credelio Plus was ≥ 97.3% against L4 larval stage of A. caninum and ≥ 98.7% against immature adult (L5) A. caninum. Conclusions These studies demonstrated that the orally administered Credelio Plus combination tablet was highly efficacious in treating immature (L4 and immature adult [L5]) stages of A. caninum in experimentally infected dogs.

scholarly journals 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 intestinal nematode infections in dogs presented as veterinary patients in Europe

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Brad Hayes ◽  
Scott Wiseman ◽  
Daniel E. Snyder
Keyword(s):  
Field Study ◽  
Drug Product ◽  
Geometric Mean ◽  
Animal Health ◽  
Good Clinical Practice ◽  
Toxocara Canis ◽  
New Combination ◽  
Combination Drug ◽  
Milbemycin Oxime ◽  
Faecal Egg Counts

Abstract Background A randomised, blinded, positive controlled, multicentre, Good Clinical Practice-compliant, pivotal field study was conducted to evaluate the effectiveness and safety of a new combination of lotilaner + milbemycin oxime tablets (Credelio® Plus; Elanco Animal Health) administered orally to client-owned dogs naturally infected with intestinal nematodes. Methods Client-owned dogs presenting to veterinary clinics from households in France, Hungary and Germany were screened for intestinal nematodes. Dogs with an initial positive faecal egg count that was subsequently confirmed with a follow-up faecal examination to demonstrate the presence of naturally occurring mixed or mono-infections with Toxocara canis, Toxascaris leonina, Trichuris vulpis or Ancylostoma caninum were enrolled on Day 0 into the study. Households were randomised in an approximately 2:1 ratio to receive either an investigational product (IP; Credelio Plus tablets) or control product (CP; Nexgard Spectra® tablets) as treatment. Dogs were administered the IP (n = 278) or CP (n = 117) once on Day 0 at a dose rate of 0.75–1.56 mg/kg bodyweight milbemycin oxime and 20.0–41.5 mg/kg bodyweight lotilaner (IP) or as recommended (CP). Effectiveness of the IP and CP treatments was based on the post-treatment reduction in geometric mean faecal egg counts on Day 8 (range Day 7–10) after treatment as compared to their pre-treatment nematode faecal egg counts. Results Geometric mean (GM) faecal egg counts for T. canis, A caninum and T. vulpis were reduced by ≥ 97.2% in the Credelio Plus group and  by ≥ 95.3% in the afoxolaner + milbemycin oxime group. There were insufficient data to calculate a percentage reduction in GM faecal egg counts between Day 0 and Day 8 for T. leonina due to low prevalence. Credelio Plus was well tolerated in this field study. Of the 355 total doses administered, 82.3% were accepted free choice in the IP group compared to 80.8% in the CP group. Conclusions This study demonstrated effectiveness (≥ 97.2% reduction), safety and tablet acceptance of a combination of milbemycin oxime and lotilaner (Credelio Plus) administered orally to dogs with natural intestinal infections of T. canis, A. caninum and T. vulpis.

scholarly journals Field study to investigate the effectiveness and safety of a novel orally administered combination drug product containing milbemycin oxime and lotilaner (Credelio® Plus) for the prevention of heartworm disease (Dirofilaria immitis) in client-owned dogs in the USA

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Lisa M. Young ◽  
Scott Wiseman ◽  
Elizabeth Crawley ◽  
Kim Wallace ◽  
Daniel E. Snyder
Keyword(s):  
Field Study ◽  
Mississippi River ◽  
Dirofilaria Immitis ◽  
Drug Product ◽  
Clinical Effectiveness ◽  
Combination Product ◽  
Combination Drug ◽  
Milbemycin Oxime ◽  
Heartworm Disease ◽  
The Usa

Abstract Background Dirofilaria immitis, a globally distributed filarial parasite of dogs, is known to cause serious or fatal cardiopulmonary disease. Client-owned dogs were enrolled in a clinical field study in the USA to evaluate the clinical effectiveness and field safety of an orally administered combination investigational product (IP) containing milbemycin oxime and lotilaner (Credelio® Plus) as compared to a control product (CP) for the prevention of heartworm disease when administered monthly for 11 consecutive months. Methods In this 11-month field study, 319 dogs ≥ 8 weeks old confirmed to be heartworm-negative were enrolled from eight geographically distinct US veterinary clinics, including sites in the southern USA and Mississippi River Valley. The dogs were treated with either the IP combination product at 0.75–1.53 mg/kg milbemycin oxime and 20–41.5 mg/kg lotilaner (n = 159) or the CP (Sentinel® Flavor Tabs®; milbemycin oxime/lufenuron) at the label-recommended dose rate (n = 158.) On day 330, effectiveness was evaluated in each dog using antigen and microfilarial (modified Knott’s) testing to assess the establishment of any patent adult heartworm infections. Results All dogs treated with the IP combination product and the CP tested negative (100% prevention) for heartworm infection on day 330. The IP combination product tablets containing milbemycin oxime and lotilaner were well tolerated based on the safety assessments in all treated dogs. Conclusions This multi-site clinical study using client-owned dogs demonstrated that monthly use of flavored, chewable tablets containing a combination of milbemycin oxime and lotilaner administered orally under end use conditions is safe for dogs. None of the enrolled dogs developed heartworm infections. Eleven consecutive monthly treatments of the IP provided 100% prevention of heartworm disease caused by D. immitis. Graphic Abstract

scholarly journals Effectiveness of Credelio® Plus, a novel chewable tablet containing milbemycin oxime and lotilaner for the treatment of larval and immature adult stages of Toxocara canis in experimentally infected dogs

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Lisa M. Young ◽  
Scott Wiseman ◽  
Elizabeth Crawley ◽  
Dwight D. Bowman ◽  
Craig R. Reinemeyer ◽  
...  
Keyword(s):  
Geometric Mean ◽  
Toxocara Canis ◽  
Time Frame ◽  
Immature Stage ◽  
Chewable Tablet ◽  
Combination Tablet ◽  
Milbemycin Oxime ◽  
Treatment Groups ◽  
Intestinal Nematode ◽  
Respective Treatment

Abstract Background The ascarid, Toxocara canis, is a common and important zoonotic intestinal nematode parasite that infects dogs globally. An effective treatment that kills any pre-patent stages of immature T. canis could additionally reduce or eliminate the development of patent infections that can result in clinical disease in infected dogs and would further reduce environmental contamination of eggs. Two randomized, blinded, GCP-compliant, pivotal laboratory dose confirmation studies were conducted to assess the effectiveness and safety of a new novel combination of lotilaner and milbemycin oxime tablets (Credelio Plus) administered orally to dogs that were experimentally infected with immature (L4 or immature adult [L5]) stages of T. canis. Methods The commercial tablet formulation of Credelio Plus® was administered in a time frame relative to inoculation with infective eggs. This allowed for effectiveness to be assessed against each specific immature stage of T. canis. In each study, dogs were randomized and allocated to one of four treatment groups. Each treatment group contained ten dogs that had been experimentally inoculated on Day 0 with infective T. canis eggs and then were dosed once on Day 14 or Day 24 using either placebo tablets or Credelio Plus tablets (IP) to provide minimum dosages of 0.75 mg/kg of milbemycin oxime and 20 mg/kg of lotilaner. All dogs were necropsied 5 or 6 days after their respective treatment. At necropsy, all nematodes recovered from the gastrointestinal tract were counted by species and stage. Results In both dose confirmation studies using geometric mean worm counts, effectiveness of Credelio Plus was ≥ 98.6% and ≥ 96.8% against L4 larval stage T. canis and immature adult [L5] T. canis in both studies, respectively. Conclusions These studies demonstrated that the Credelio Plus combination tablet administered orally to dogs was highly efficacious against experimental infections with L4 and immature adult [L5] stages of T. canis.

Bioequivalence of Dapagliflozin/Metformin Extended-release Fixed-combination Drug Product and Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Russian Subjects

2018 ◽  
Vol 40 (4) ◽  
pp. 550-561.e3 ◽  
Author(s):  
Yunona Khomitskaya ◽  
Nadezhda Tikhonova ◽  
Konstantin Gudkov ◽  
Svetlana Erofeeva ◽  
Victoria Holmes ◽  
...  
Keyword(s):  
Extended Release ◽  
Fixed Combination ◽  
Drug Product ◽  
Single Component ◽  
Combination Drug

scholarly journals THE DISTRIBUTION OF RICKETTSIA IN THE TISSUES OF INSECTS AND ARACHNIDS

1923 ◽  
Vol 37 (4) ◽  
pp. 431-456 ◽  
Author(s):  
E. V. Cowdry
Keyword(s):  
Rhipicephalus Sanguineus ◽  
Dermacentor Variabilis ◽  
Animal Products ◽  
Gram Negative ◽  
Pediculus Humanus ◽  
Larval Stages ◽  
Pulex Irritans ◽  
Boophilus Decoloratus ◽  
Occasional Occurrence ◽  
Definition Of

In the absence of a satisfactory definition of Rickettsia the observations herein recorded were arbitrarily limited to bacterium-like organisms which are intracellular and Gram-negative. Rickettsia of this type were found in the following species: Amblyomma americana, Amblyomma hebræum, Boophilus decoloratus, Atomus sp., Casinaria infesta, Chrysopa oculata, Ctenocephalus canis, Dermacentor variabilis, Lepisma saccharina, Lucoppia curviseta, Margaropus annulatus, Margaropus annulatus australis, Ornithodoros turicata, Pulex irritans, Rhipicephalus sanguineus, Rhipicephalus evertsi, and Salticus scenicus. Since intracellular, Gram-negative Rickettsia have been recorded in the literature as existing in Cimex lectularius, Dermacentor venustus, Melophagus ovinus, and Pediculus humanus, the occasional occurrence of such bodies must be conceded in the following groups not closely related phylogenetically: Attidæ, Trombidiidæ, Argasidæ, lxodidæ, Cinura, Acanthiidæ, Pediculidæ, Hippoboscidæ, Chrysopidæ, Pulicidæ, and Ichneumonidæ. The species which harbor Rickettsia differ widely in diet and habitat. One such species is insectivorous throughout life, two are insectivorous in larval stages, becoming vegetarian in the adult condition, one is chiefly vegetarian but partakes of some animal products, and two are usually entirely vegetarian; while the remainder subsist wholly upon a diet of mammalian blood. Rickettsia are associated, in only a few cases, with diseases in mammals. The evidence at hand does not lead beyond the conclusion that the Rickettsia mentioned above are true Gram-negative microorganisms, easily distinguishable from mitochondria and all other cytoplasmic and nuclear granulations, rather completely adapted to an intracellular existence, exhibiting in some cases a remarkable degree of host specificity, and often inherited through the eggs.

scholarly journals Ticks and fleas in crab-eating fox (Cerdocyon thous) of Pernambuco state, Brazil

2016 ◽  
Vol 53 (3) ◽  
pp. 295
Author(s):  
Edna Michelly de Sá Santos ◽  
Ricardo César De Souza Carneiro da Cunha ◽  
Márcia Paula Oliveira Farias ◽  
Cristina Farias da Fonseca ◽  
Jaqueline Bianque de Oliveira ◽  
...  
Keyword(s):  
Rhipicephalus Sanguineus ◽  
Ctenocephalides Felis ◽  
Amblyomma Ovale ◽  
Pulex Irritans ◽  
Rhipicephalus Sanguineus Sensu Lato ◽  
Cerdocyon Thous

Objetivou-se identificar as espécies de pulgas e carrapatos de Cerdocyon thous provenientes do estado Pernambuco. Foram examinados 20 animais, estando 30% (6/20) ectoparasitados. Foram coletadas 16 pulgas e 17 carrapatos em cachorros-do-mato de vida livre e de cativeiro no estado de Pernambuco. As pulgas foram identificadas como: Pulex irritans e Ctenocephalides felis; e os carrapatos foram: Rhipicephalus sanguineus sensu lato e Amblyomma ovale. A presença de ectoparasitos de animais domésticos parasitando C. thous, sugere a aproximação de indivíduos desta espécie ao peridomicílio. Além disso, este é o primeiro relato da ocorrência de A. ovale em C. thous no nordeste brasileiro.

Clinical efficacy of milbemycin oxime in the treatment of nasal mite infection in dogs

1999 ◽  
Vol 35 (1) ◽  
pp. 81-84 ◽  
Author(s):  
LK Gunnarsson ◽  
LC Moller ◽  
AM Einarsson ◽  
G Zakrisson ◽  
BG Hagman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Body Weight ◽  
Clinical Efficacy ◽  
Clinical Signs ◽  
Caninum Infection ◽  
Milbemycin Oxime

A multicentric clinical trial was done to evaluate the clinical efficacy of milbemycin oxime in the treatment of nasal mite (Pneumonyssoides caninum) infection in dogs. Milbemycin oxime was given to 70 dogs of different breeds, genders, and ages, with clinical signs associated with nasal mite infection. Twenty-five dogs had a verified infection, and 45 dogs had signs suggestive of nasal mite infection. Milbemycin oxime was given at the dosage of 0.5 to 1.0 mg/kg body weight orally once a week for three consecutive weeks. One month after initiation of treatment, 68 of the dogs had no more clinical signs associated with nasal mite infection.

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