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Sean P Mahabir - One of the best experts on this subject based on the ideXlab platform.
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safety and efficacy of a novel oral chewable combination tablet containing sarolaner moxidectin and pyrantel simparica trio against natural Flea infestations in client owned dogs in the usa
Parasites & Vectors, 2020Co-Authors: Kristina Kryda, Sean P Mahabir, Tammy Inskeep, Jady J RuggAbstract:One randomized, controlled clinical field study was conducted in 18 general veterinary practices throughout the USA to evaluate the safety and efficacy of a novel oral chewable combination tablet, Simparica Trio™, containing sarolaner, moxidectin and pyrantel for the treatment and prevention of Fleas on dogs. Client-owned dogs, from households of three or fewer dogs were eligible for enrollment. Four hundred and twenty-two dogs from 251 households were enrolled. Households were randomly assigned in a 2:1 ratio to treatment with either Simparica Trio™ at the minimum label dose of 1.2 mg/kg sarolaner, 24 µg/kg moxidectin and 5 mg/kg pyrantel (as pamoate salt) or afoxolaner (NexGard®, Boehringer-Ingelheim) at the label dose. One dog per household was selected as the primary dog for efficacy evaluations. Treatments were dispensed and dogs were dosed in their home environment on Day 0 and on approximately Day 30. Flea counts and examination for clinical signs of Flea Allergy Dermatitis (FAD) were performed at the initial visit the day before or on Day 0 prior to treatment and on Days 30 and 60. Additionally, all dogs were examined for general health at each visit and blood and urine were collected for clinical pathology at screening and Day 60. Simparica Trio™ reduced geometric mean live Flea counts by 99.0% by Day 30 and by 99.7% by Day 60. As a result of the rapid reduction in Flea infestations, clinical signs associated with FAD substantially improved following treatment. Simparica Trio™ was well-tolerated and a diverse range of concomitant medications were administered to dogs during the course of the study. Simparica Trio™ chewable tablets were well-accepted by dogs, with the majority of flavored chewable tablets (91.9%) voluntarily consumed by free choice without, or when offered in food. Simparica Trio™ administered orally once monthly for two consecutive treatments was safe and effective against natural Flea infestations and substantially improved clinical signs associated with FAD in client-owned dogs in a field study conducted in the USA.
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efficacy of a novel oral chewable tablet containing sarolaner moxidectin and pyrantel simparica trio against natural Flea and tick infestations on dogs presented as veterinary patients in europe
Parasites & Vectors, 2020Co-Authors: Csilla Becskei, Sean P Mahabir, Daphne Fias, Róbert FarkasAbstract:A novel chewable oral tablet containing sarolaner, moxidectin and pyrantel (Simparica Trio™) has recently been developed to provide persistent protection against Flea and tick infections for a month, treatment of hookworm and roundworm infections and prevention of heartworm and lungworm disease in dogs. Two field studies were conducted to evaluate the safety and efficacy of Simparica Trio™ against natural Flea and tick infestations on dogs in Europe. Dogs with natural Flea or tick infestations were allocated randomly to treatment on Day 0 with either Simparica Trio™ tablets (Flea study: n = 297; tick study: n = 189) to provide 1.2–2.4 mg/kg sarolaner, 24–48 µg/kg moxidectin and 5–10 mg/kg pyrantel (as pamoate salt) or with NexGard® Spectra (afoxolaner + milbemycin oxime) according to the label instructions (Flea study: n = 164; tick study: n = 91). Efficacy was calculated based on the mean percent reduction in live parasite counts compared to the respective pre-treatment counts on Days 14 and 30 in the Flea study and on Days 7, 14, 21 and 30 in the tick study. To count the Fleas, the dog’s entire coat was systematically combed using an extra fine-tooth Flea comb until all Fleas were removed. For the tick counts, the dog’s entire coat was searched manually. Resolution of the clinical signs of Flea Allergy Dermatitis (FAD) was assessed in Flea allergic dogs in the Flea study. Palatability was assessed in both studies. Simparica Trio™ was well tolerated in both studies. Efficacy against Fleas was ≥ 97.9% in the Simparica Trio™ group and ≥ 96.1% in the NexGard® Spectra group. Efficacy against ticks was ≥ 94.8% in the Simparica Trio™ group and ≥ 94.4% in the NexGard® Spectra group. Clinical signs of Flea Allergy Dermatitis improved following treatment with Simparica Trio™. Simparica Trio™ tablets were voluntarily and fully consumed on ≥ 78% of the 485 occasions they were offered. A single oral dose of Simparica Trio™ was safe and highly efficacious against naturally occurring Flea and tick infestations for 1 month on dogs. Clinical signs of FAD improved following treatment. Simparica Trio™ was voluntarily and readily consumed by most dogs.
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comparative speed of kill of sarolaner simparica and spinosad plus milbemycin oxime trifexis against induced infestations of ctenocephalides felis on dogs
Parasites & Vectors, 2016Co-Authors: Robert H Six, Melanie R Myers, William R Everett, Sean P MahabirAbstract:Fleas are a ubiquitous ectoparasite infesting dogs and cause direct discomfort, allergic reactions and are responsible for the transmission of several pathogens. The rapid speed of kill of a parasiticide is important to alleviate the direct deleterious effects of Fleas, reduce the impact of allergic responses, and break the Flea life cycle. In this study, the speed of kill of a novel orally administered isoxazoline parasiticide, sarolaner (Simparica™) against Fleas on dogs was evaluated and compared with spinosad in combination with milbemycin oxime (Trifexis®) for 5 weeks after a single oral dose. Twenty-four dogs were randomly allocated to treatment with a single oral dose per product label of sarolaner (2 to 4 mg/kg), spinosad/milbemycin oxime (30 to 60 mg/kg / 0.2 to 0.4 mg/kg), or placebo based on pretreatment Flea counts. Dogs were combed and live Fleas counted at 8, 12, and 24 h after treatment and subsequent re-infestations on Days 7, 14, 21, 28, and 35. Efficacy (reduction in live Flea counts) of each treatment was determined at each time point relative to counts for placebo dogs. There were no adverse reactions to treatment. A single oral dose of sarolaner provided ≥94.0 % efficacy (based on geometric means) within 8 h of treatment or subsequent weekly re-infestations of Fleas to Day 35. By 12 h, Fleas were eradicated from all dogs and they remained Flea free at 24 h. Significantly greater numbers of live Fleas were recovered from spinosad/milbemycin oxime-treated dogs at 8 h from Day 21 to Day 35 (P ≤ 0.0085), and at 12 and 24 h on Day 35 (P ≤ 0.0002). In this controlled laboratory evaluation, dogs treated with sarolaner had significantly fewer live Fleas than spinosad/milbemycin oxime- treated dogs at 8 h after re-infestation from Day 21 after a single oral dose. The rapid and consistent kill of Fleas after a single oral dose of sarolaner over 35 days indicates that this treatment should provide highly effective control of Flea infestations, relief for dogs afflicted with Flea Allergy Dermatitis, and also reduce the risk of transmission of Flea-borne pathogens.
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comparative speed of kill of sarolaner simparica and fluralaner bravecto against induced infestations of ctenocephalides felis on dogs
Parasites & Vectors, 2016Co-Authors: Robert H Six, Julian Liebenberg, Nicole Honsberger, Sean P MahabirAbstract:Fleas are the most common ectoparasite infesting dogs globally and cause direct discomfort, induce allergic reactions, and transmit pathogenic agents. Rapid speed of kill is an important characteristic for a parasiticide in order to alleviate the direct deleterious effects of Fleas, reduce the impact of allergic responses, and break the Flea life cycle. In this study, the speed of kill of a novel, orally administered isoxazoline parasiticide, sarolaner (Simparica™), against Fleas on dogs was evaluated and compared with fluralaner (Bravecto®) over a 3-month period. Based on pretreatment Flea counts, 24 dogs were randomly allocated to treatment with oral sarolaner at the label rate (2 to 4 mg/kg), once a month for 3 months, or oral fluralaner (25 to 50 mg/kg), once per label directions, or placebo. Dogs were combed and live Fleas counted at 8, 12, and 24 h after treatment and subsequent re-infestations on Days 14, 29, 44, 59, 74 and 90. Efficacy was determined at each time point relative to counts for placebo dogs. There were no adverse reactions to treatment. Three monthly doses of sarolaner provided ≥97.6 % efficacy (based on arithmetic means) within 8 h of treatment or subsequent weekly re-infestations of Fleas for 3 months. By 12 h, Fleas were eradicated from all dogs (100 % efficacy). Significantly greater numbers of live Fleas were recovered from fluralaner-treated dogs at 8 h on Days 74 and 90 (P ≤ 0.0043) when efficacy (based on arithmetic means) was only 80.7 and 72.6 %, respectively. In this controlled laboratory evaluation, sarolaner had a significantly faster speed of kill against Fleas than fluralaner at the end of its claimed treatment period. The rapid and consistent kill of Fleas within 8 to 12 h after monthly oral doses of sarolaner indicates that this treatment will provide rapid and highly effective control of Flea infestations, and suggests that it will provide relief for dogs suffering from Flea Allergy Dermatitis, and should reduce the risk of Flea-borne pathogen transmission.
Douglas Rugg - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of a combination of selamectin plus sarolaner for the treatment and prevention of Flea infestations and the treatment of ear mites in cats presented as veterinary patients in the united states
Veterinary Parasitology, 2019Co-Authors: Adriano F. Vatta, Vickie L King, Sara Chapin, Melanie R Myers, Jady J Rugg, Aleah Pullins, Douglas RuggAbstract:Abstract Two randomised, single-masked, multi-center field studies were conducted in the United States in cats presented as veterinary patients. The first study evaluated the efficacy and safety of a topically applied formulation of selamectin plus sarolaner (Revolution® Plus/Stronghold® Plus, Zoetis) against natural Flea infestations; the second study evaluated its efficacy against natural ear mite infestations. The product was administered topically by the cats’ owners at the dose range provided in the market product of 6.0–12.0 mg selamectin and 1.0–2.0 mg sarolaner per kg bodyweight. Imidacloprid plus moxidectin (Advantage® Multi for Cats, Bayer) was used as a positive control in both studies at the label dosage. In the Flea study, treatments were administered on Days 0, 30, and 60. Efficacy was calculated based on the mean percent reduction of live Flea counts on Days 30, 60, and 90 relative to the pre-treatment count. In the ear mite study, a single treatment was applied on Day 0 and efficacy was determined on Days 14 and 30 based on the presence or absence of ear mites. In both studies, patients were randomly allocated to treatments in the ratio of 2:1, selamectin plus sarolaner: imidacloprid plus moxidectin. In the two studies, 405 cats received treatment with selamectin plus sarolaner; of these, 256 cats received three monthly treatments in the Flea study. There were no serious adverse reactions to treatment with selamectin plus sarolaner; health issues noted were typical of the normal ailments or minor traumatic injuries expected in the general cat population and were similar in both treatment groups. Efficacy against Fleas based on geometric (arithmetic) means was 97.2% (95.9%), 99.5% (99.4%), and 99.8% (99.8%) in the selamectin plus sarolaner group and was 79.7% (70.5%), 91.4% (77.3%), and 95.5% (87.4%) in the imidacloprid plus moxidectin group on Days 30, 60, and 90, respectively. Flea counts for the selamectin plus sarolaner group were significantly lower than the counts for the imidacloprid plus moxidectin group at all time-points after treatment administration on Day 0 (P In the ear mite study, a single application of selamectin plus sarolaner resulted in the clearance of mites from 87.5% of cats within 14 days and 94.4% of cats within 30 days of treatment. The respective percentages of mite-free cats in the imidacloprid plus moxidectin group were 64.0% and 72.0%. There were significantly more cats with no mites noted in the selamectin plus sarolaner group than in the imidacloprid plus moxidectin group on Day 14 and Day 30 (P ≤ 0.018). Selamectin plus sarolaner (Revolution® Plus/Stronghold® Plus) administered topically at monthly intervals for three months was well tolerated and highly effective for the treatment and prevention of natural infestations of Fleas on cats presented as veterinary patients. Clinical signs of Flea Allergy Dermatitis improved in affected cats following treatment administration. A single topical treatment was also safe and highly effective for the treatment of ear mite infestations in naturally infested cats.
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efficacy of a new topical formulation of selamectin plus sarolaner for the control of Fleas and ticks infesting cats in japan
Veterinary Parasitology, 2019Co-Authors: Wakako Yonetake, Andrew Hodge, Masaya Naito, Steven Maeder, Takeshi Fujii, Douglas RuggAbstract:Abstract The efficacy of a single application of a new topical formulation containing selamectin plus sarolaner (Revolution® Plus / Stronghold® Plus, Zoetis) was evaluated against Fleas and ticks infesting cats enrolled as veterinary patients in two field studies conducted in Japan and against Haemaphysalis longicornis ticks on cats in a laboratory study. In the laboratory study, sixteen cats were ranked based on pre-treatment tick counts and allocated randomly to treatment on Day 0 with either selamectin plus sarolaner or placebo. Cats were infested with adult H. longicornis on Days −2, 5, 12, 19, 26 and 33. Efficacy relative to placebo was based on live attached tick counts conducted 48 h after treatment and subsequent re-infestations. Selamectin plus sarolaner reduced live, attached H. longicornis counts by 96.4% within 48 h of treatment, and by ≥91.7% within 48 h of weekly re-infestation for 35 days, based on arithmetic means. In the field studies, 67 client-owned cats harboring six or more live Fleas and 63 cats harboring four or more live attached ticks were enrolled to evaluate selamectin plus sarolaner for efficacy and safety compared with a registered product. Cats were allocated randomly to treatment with selamectin plus sarolaner or fipronil plus (S)-methoprene based on order of presentation. Treatment was administered once on Day 0 and efficacy was assessed by parasite counts conducted on Days 14 and 30 compared to the pre-treatment count. In the Flea field study, live Flea counts on Days 14 and 30 were reduced by 99.5% and 99.9% in the selamectin plus sarolaner group, and by 97.6% and 98.6% in the fipronil plus (S)-methoprene group, based on least squares mean percentage reductions. Clinical signs typically associated with Flea Allergy Dermatitis improved following treatment. In the tick field study, live tick counts on Days 14 and 30 were reduced by 97.5% and 97.7% in the selamectin plus sarolaner group, and by 91.5% and 93.4% in the fipronil plus (S)-methoprene group, based on least squares mean percentage reductions. Selamectin plus sarolaner was determined to be non-inferior to fipronil plus (S)-methoprene in both field studies. There were no treatment-related adverse events in any study. A single topical dose of Revolution® Plus / Stronghold® Plus providing a minimum dosage of 6.0 mg/kg selamectin and 1.0 mg/kg sarolaner was confirmed to be effective against H. longicornis ticks on cats for one month and safe and effective in the treatment of Fleas and ticks on cats enrolled as veterinary patients in Japan.
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efficacy and safety of a new spot on formulation of selamectin plus sarolaner in the treatment of naturally occurring Flea and tick infestations in cats presented as veterinary patients in europe
Veterinary Parasitology, 2017Co-Authors: Thomas Geurden, Csilla Becskei, Róbert Farkas, Douglas RuggAbstract:Abstract Two randomised, blinded, multi-centre field studies were conducted in Europe (Germany, Italy, France, Hungary) to demonstrate the efficacy and safety of three monthly applications of a new spot-on formulation of selamectin plus sarolaner (Stronghold® Plus, Zoetis) against natural Flea or tick infestations in cats presented as veterinary patients. The spot-on formulation was administered at the commercial dose range of 6.0–12.0 mg selamectin and 1.0–2.0 mg sarolaner per kg bodyweight. In the Flea study, the improvement in clinical signs associated with Flea Allergy Dermatitis (FAD) was also monitored. Imidacloprid plus moxidectin (Advocate® for Cats, Bayer) and fipronil (Frontline® Spot on, Merial) were used as positive control products in the Flea and tick studies, respectively. Treatments were administered on Days 0, 30 and 60. Efficacy was calculated based on the mean percent reduction of live parasite counts on post-treatment days 14, 30, 60 and 90 versus the pre-treatment count on Day 0. Non-inferiority of selamectin/sarolaner to the control products was assessed at each time-point using a non-inferiority margin of 15% at the one-sided 0.025 significance level. Cats were enrolled in a 2:1 ratio (selamectin/sarolaner:comparator). In the Flea study, 277 cats were assessed for efficacy and safety, and an additional 170 cats were assessed for safety only. On days 14, 30, 60 and 90, efficacy against Fleas was 97.4%, 97.3%, 98.8% and 99.4% in the selamectin/sarolaner-treated group and was 90.0%, 83.6%, 87.7% and 96.3% in the imidacloprid/moxidectin-treated group, respectively. Selamectin/sarolaner was non-inferior to imidacloprid/moxidectin at all time-points. For the 16 cats identified as having FAD at enrolment, clinical signs related to FAD improved following treatment administration. In the tick study, 200 cats were assessed for efficacy and safety, and a further 70 cats were assessed for safety only. Four tick species were identified. Overall efficacy against ticks was 96.7%, 92.6%, 98.8% and 99.5% in the selamectin/sarolaner-treated group and was 90.2%, 74.6%, 83.0% and 93.4% in the fipronil-treated group on Days 14, 30, 60 and 90, respectively. Selamectin/sarolaner was non-inferior to fipronil at all time-points, and was superior on Days 30 and 60. There were no serious treatment-related adverse events in any study. Thus, the new spot-on formulation of selamectin plus sarolaner administered at monthly intervals was safe and highly effective against natural infestations of Fleas and ticks on cats, and improved clinical signs of FAD.
Róbert Farkas - One of the best experts on this subject based on the ideXlab platform.
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efficacy of a novel oral chewable tablet containing sarolaner moxidectin and pyrantel simparica trio against natural Flea and tick infestations on dogs presented as veterinary patients in europe
Parasites & Vectors, 2020Co-Authors: Csilla Becskei, Sean P Mahabir, Daphne Fias, Róbert FarkasAbstract:A novel chewable oral tablet containing sarolaner, moxidectin and pyrantel (Simparica Trio™) has recently been developed to provide persistent protection against Flea and tick infections for a month, treatment of hookworm and roundworm infections and prevention of heartworm and lungworm disease in dogs. Two field studies were conducted to evaluate the safety and efficacy of Simparica Trio™ against natural Flea and tick infestations on dogs in Europe. Dogs with natural Flea or tick infestations were allocated randomly to treatment on Day 0 with either Simparica Trio™ tablets (Flea study: n = 297; tick study: n = 189) to provide 1.2–2.4 mg/kg sarolaner, 24–48 µg/kg moxidectin and 5–10 mg/kg pyrantel (as pamoate salt) or with NexGard® Spectra (afoxolaner + milbemycin oxime) according to the label instructions (Flea study: n = 164; tick study: n = 91). Efficacy was calculated based on the mean percent reduction in live parasite counts compared to the respective pre-treatment counts on Days 14 and 30 in the Flea study and on Days 7, 14, 21 and 30 in the tick study. To count the Fleas, the dog’s entire coat was systematically combed using an extra fine-tooth Flea comb until all Fleas were removed. For the tick counts, the dog’s entire coat was searched manually. Resolution of the clinical signs of Flea Allergy Dermatitis (FAD) was assessed in Flea allergic dogs in the Flea study. Palatability was assessed in both studies. Simparica Trio™ was well tolerated in both studies. Efficacy against Fleas was ≥ 97.9% in the Simparica Trio™ group and ≥ 96.1% in the NexGard® Spectra group. Efficacy against ticks was ≥ 94.8% in the Simparica Trio™ group and ≥ 94.4% in the NexGard® Spectra group. Clinical signs of Flea Allergy Dermatitis improved following treatment with Simparica Trio™. Simparica Trio™ tablets were voluntarily and fully consumed on ≥ 78% of the 485 occasions they were offered. A single oral dose of Simparica Trio™ was safe and highly efficacious against naturally occurring Flea and tick infestations for 1 month on dogs. Clinical signs of FAD improved following treatment. Simparica Trio™ was voluntarily and readily consumed by most dogs.
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efficacy and safety of a new spot on formulation of selamectin plus sarolaner in the treatment of naturally occurring Flea and tick infestations in cats presented as veterinary patients in europe
Veterinary Parasitology, 2017Co-Authors: Thomas Geurden, Csilla Becskei, Róbert Farkas, Douglas RuggAbstract:Abstract Two randomised, blinded, multi-centre field studies were conducted in Europe (Germany, Italy, France, Hungary) to demonstrate the efficacy and safety of three monthly applications of a new spot-on formulation of selamectin plus sarolaner (Stronghold® Plus, Zoetis) against natural Flea or tick infestations in cats presented as veterinary patients. The spot-on formulation was administered at the commercial dose range of 6.0–12.0 mg selamectin and 1.0–2.0 mg sarolaner per kg bodyweight. In the Flea study, the improvement in clinical signs associated with Flea Allergy Dermatitis (FAD) was also monitored. Imidacloprid plus moxidectin (Advocate® for Cats, Bayer) and fipronil (Frontline® Spot on, Merial) were used as positive control products in the Flea and tick studies, respectively. Treatments were administered on Days 0, 30 and 60. Efficacy was calculated based on the mean percent reduction of live parasite counts on post-treatment days 14, 30, 60 and 90 versus the pre-treatment count on Day 0. Non-inferiority of selamectin/sarolaner to the control products was assessed at each time-point using a non-inferiority margin of 15% at the one-sided 0.025 significance level. Cats were enrolled in a 2:1 ratio (selamectin/sarolaner:comparator). In the Flea study, 277 cats were assessed for efficacy and safety, and an additional 170 cats were assessed for safety only. On days 14, 30, 60 and 90, efficacy against Fleas was 97.4%, 97.3%, 98.8% and 99.4% in the selamectin/sarolaner-treated group and was 90.0%, 83.6%, 87.7% and 96.3% in the imidacloprid/moxidectin-treated group, respectively. Selamectin/sarolaner was non-inferior to imidacloprid/moxidectin at all time-points. For the 16 cats identified as having FAD at enrolment, clinical signs related to FAD improved following treatment administration. In the tick study, 200 cats were assessed for efficacy and safety, and a further 70 cats were assessed for safety only. Four tick species were identified. Overall efficacy against ticks was 96.7%, 92.6%, 98.8% and 99.5% in the selamectin/sarolaner-treated group and was 90.2%, 74.6%, 83.0% and 93.4% in the fipronil-treated group on Days 14, 30, 60 and 90, respectively. Selamectin/sarolaner was non-inferior to fipronil at all time-points, and was superior on Days 30 and 60. There were no serious treatment-related adverse events in any study. Thus, the new spot-on formulation of selamectin plus sarolaner administered at monthly intervals was safe and highly effective against natural infestations of Fleas and ticks on cats, and improved clinical signs of FAD.
Jady J Rugg - One of the best experts on this subject based on the ideXlab platform.
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safety and efficacy of a novel oral chewable combination tablet containing sarolaner moxidectin and pyrantel simparica trio against natural Flea infestations in client owned dogs in the usa
Parasites & Vectors, 2020Co-Authors: Kristina Kryda, Sean P Mahabir, Tammy Inskeep, Jady J RuggAbstract:One randomized, controlled clinical field study was conducted in 18 general veterinary practices throughout the USA to evaluate the safety and efficacy of a novel oral chewable combination tablet, Simparica Trio™, containing sarolaner, moxidectin and pyrantel for the treatment and prevention of Fleas on dogs. Client-owned dogs, from households of three or fewer dogs were eligible for enrollment. Four hundred and twenty-two dogs from 251 households were enrolled. Households were randomly assigned in a 2:1 ratio to treatment with either Simparica Trio™ at the minimum label dose of 1.2 mg/kg sarolaner, 24 µg/kg moxidectin and 5 mg/kg pyrantel (as pamoate salt) or afoxolaner (NexGard®, Boehringer-Ingelheim) at the label dose. One dog per household was selected as the primary dog for efficacy evaluations. Treatments were dispensed and dogs were dosed in their home environment on Day 0 and on approximately Day 30. Flea counts and examination for clinical signs of Flea Allergy Dermatitis (FAD) were performed at the initial visit the day before or on Day 0 prior to treatment and on Days 30 and 60. Additionally, all dogs were examined for general health at each visit and blood and urine were collected for clinical pathology at screening and Day 60. Simparica Trio™ reduced geometric mean live Flea counts by 99.0% by Day 30 and by 99.7% by Day 60. As a result of the rapid reduction in Flea infestations, clinical signs associated with FAD substantially improved following treatment. Simparica Trio™ was well-tolerated and a diverse range of concomitant medications were administered to dogs during the course of the study. Simparica Trio™ chewable tablets were well-accepted by dogs, with the majority of flavored chewable tablets (91.9%) voluntarily consumed by free choice without, or when offered in food. Simparica Trio™ administered orally once monthly for two consecutive treatments was safe and effective against natural Flea infestations and substantially improved clinical signs associated with FAD in client-owned dogs in a field study conducted in the USA.
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efficacy and safety of a combination of selamectin plus sarolaner for the treatment and prevention of Flea infestations and the treatment of ear mites in cats presented as veterinary patients in the united states
Veterinary Parasitology, 2019Co-Authors: Adriano F. Vatta, Vickie L King, Sara Chapin, Melanie R Myers, Jady J Rugg, Aleah Pullins, Douglas RuggAbstract:Abstract Two randomised, single-masked, multi-center field studies were conducted in the United States in cats presented as veterinary patients. The first study evaluated the efficacy and safety of a topically applied formulation of selamectin plus sarolaner (Revolution® Plus/Stronghold® Plus, Zoetis) against natural Flea infestations; the second study evaluated its efficacy against natural ear mite infestations. The product was administered topically by the cats’ owners at the dose range provided in the market product of 6.0–12.0 mg selamectin and 1.0–2.0 mg sarolaner per kg bodyweight. Imidacloprid plus moxidectin (Advantage® Multi for Cats, Bayer) was used as a positive control in both studies at the label dosage. In the Flea study, treatments were administered on Days 0, 30, and 60. Efficacy was calculated based on the mean percent reduction of live Flea counts on Days 30, 60, and 90 relative to the pre-treatment count. In the ear mite study, a single treatment was applied on Day 0 and efficacy was determined on Days 14 and 30 based on the presence or absence of ear mites. In both studies, patients were randomly allocated to treatments in the ratio of 2:1, selamectin plus sarolaner: imidacloprid plus moxidectin. In the two studies, 405 cats received treatment with selamectin plus sarolaner; of these, 256 cats received three monthly treatments in the Flea study. There were no serious adverse reactions to treatment with selamectin plus sarolaner; health issues noted were typical of the normal ailments or minor traumatic injuries expected in the general cat population and were similar in both treatment groups. Efficacy against Fleas based on geometric (arithmetic) means was 97.2% (95.9%), 99.5% (99.4%), and 99.8% (99.8%) in the selamectin plus sarolaner group and was 79.7% (70.5%), 91.4% (77.3%), and 95.5% (87.4%) in the imidacloprid plus moxidectin group on Days 30, 60, and 90, respectively. Flea counts for the selamectin plus sarolaner group were significantly lower than the counts for the imidacloprid plus moxidectin group at all time-points after treatment administration on Day 0 (P In the ear mite study, a single application of selamectin plus sarolaner resulted in the clearance of mites from 87.5% of cats within 14 days and 94.4% of cats within 30 days of treatment. The respective percentages of mite-free cats in the imidacloprid plus moxidectin group were 64.0% and 72.0%. There were significantly more cats with no mites noted in the selamectin plus sarolaner group than in the imidacloprid plus moxidectin group on Day 14 and Day 30 (P ≤ 0.018). Selamectin plus sarolaner (Revolution® Plus/Stronghold® Plus) administered topically at monthly intervals for three months was well tolerated and highly effective for the treatment and prevention of natural infestations of Fleas on cats presented as veterinary patients. Clinical signs of Flea Allergy Dermatitis improved in affected cats following treatment administration. A single topical treatment was also safe and highly effective for the treatment of ear mite infestations in naturally infested cats.
Csilla Becskei - One of the best experts on this subject based on the ideXlab platform.
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efficacy of a novel oral chewable tablet containing sarolaner moxidectin and pyrantel simparica trio against natural Flea and tick infestations on dogs presented as veterinary patients in europe
Parasites & Vectors, 2020Co-Authors: Csilla Becskei, Sean P Mahabir, Daphne Fias, Róbert FarkasAbstract:A novel chewable oral tablet containing sarolaner, moxidectin and pyrantel (Simparica Trio™) has recently been developed to provide persistent protection against Flea and tick infections for a month, treatment of hookworm and roundworm infections and prevention of heartworm and lungworm disease in dogs. Two field studies were conducted to evaluate the safety and efficacy of Simparica Trio™ against natural Flea and tick infestations on dogs in Europe. Dogs with natural Flea or tick infestations were allocated randomly to treatment on Day 0 with either Simparica Trio™ tablets (Flea study: n = 297; tick study: n = 189) to provide 1.2–2.4 mg/kg sarolaner, 24–48 µg/kg moxidectin and 5–10 mg/kg pyrantel (as pamoate salt) or with NexGard® Spectra (afoxolaner + milbemycin oxime) according to the label instructions (Flea study: n = 164; tick study: n = 91). Efficacy was calculated based on the mean percent reduction in live parasite counts compared to the respective pre-treatment counts on Days 14 and 30 in the Flea study and on Days 7, 14, 21 and 30 in the tick study. To count the Fleas, the dog’s entire coat was systematically combed using an extra fine-tooth Flea comb until all Fleas were removed. For the tick counts, the dog’s entire coat was searched manually. Resolution of the clinical signs of Flea Allergy Dermatitis (FAD) was assessed in Flea allergic dogs in the Flea study. Palatability was assessed in both studies. Simparica Trio™ was well tolerated in both studies. Efficacy against Fleas was ≥ 97.9% in the Simparica Trio™ group and ≥ 96.1% in the NexGard® Spectra group. Efficacy against ticks was ≥ 94.8% in the Simparica Trio™ group and ≥ 94.4% in the NexGard® Spectra group. Clinical signs of Flea Allergy Dermatitis improved following treatment with Simparica Trio™. Simparica Trio™ tablets were voluntarily and fully consumed on ≥ 78% of the 485 occasions they were offered. A single oral dose of Simparica Trio™ was safe and highly efficacious against naturally occurring Flea and tick infestations for 1 month on dogs. Clinical signs of FAD improved following treatment. Simparica Trio™ was voluntarily and readily consumed by most dogs.
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efficacy and safety of a new spot on formulation of selamectin plus sarolaner in the treatment of naturally occurring Flea and tick infestations in cats presented as veterinary patients in europe
Veterinary Parasitology, 2017Co-Authors: Thomas Geurden, Csilla Becskei, Róbert Farkas, Douglas RuggAbstract:Abstract Two randomised, blinded, multi-centre field studies were conducted in Europe (Germany, Italy, France, Hungary) to demonstrate the efficacy and safety of three monthly applications of a new spot-on formulation of selamectin plus sarolaner (Stronghold® Plus, Zoetis) against natural Flea or tick infestations in cats presented as veterinary patients. The spot-on formulation was administered at the commercial dose range of 6.0–12.0 mg selamectin and 1.0–2.0 mg sarolaner per kg bodyweight. In the Flea study, the improvement in clinical signs associated with Flea Allergy Dermatitis (FAD) was also monitored. Imidacloprid plus moxidectin (Advocate® for Cats, Bayer) and fipronil (Frontline® Spot on, Merial) were used as positive control products in the Flea and tick studies, respectively. Treatments were administered on Days 0, 30 and 60. Efficacy was calculated based on the mean percent reduction of live parasite counts on post-treatment days 14, 30, 60 and 90 versus the pre-treatment count on Day 0. Non-inferiority of selamectin/sarolaner to the control products was assessed at each time-point using a non-inferiority margin of 15% at the one-sided 0.025 significance level. Cats were enrolled in a 2:1 ratio (selamectin/sarolaner:comparator). In the Flea study, 277 cats were assessed for efficacy and safety, and an additional 170 cats were assessed for safety only. On days 14, 30, 60 and 90, efficacy against Fleas was 97.4%, 97.3%, 98.8% and 99.4% in the selamectin/sarolaner-treated group and was 90.0%, 83.6%, 87.7% and 96.3% in the imidacloprid/moxidectin-treated group, respectively. Selamectin/sarolaner was non-inferior to imidacloprid/moxidectin at all time-points. For the 16 cats identified as having FAD at enrolment, clinical signs related to FAD improved following treatment administration. In the tick study, 200 cats were assessed for efficacy and safety, and a further 70 cats were assessed for safety only. Four tick species were identified. Overall efficacy against ticks was 96.7%, 92.6%, 98.8% and 99.5% in the selamectin/sarolaner-treated group and was 90.2%, 74.6%, 83.0% and 93.4% in the fipronil-treated group on Days 14, 30, 60 and 90, respectively. Selamectin/sarolaner was non-inferior to fipronil at all time-points, and was superior on Days 30 and 60. There were no serious treatment-related adverse events in any study. Thus, the new spot-on formulation of selamectin plus sarolaner administered at monthly intervals was safe and highly effective against natural infestations of Fleas and ticks on cats, and improved clinical signs of FAD.