Efficacy of a novel topical combination of esafoxolaner, eprinomectin and praziquantel against Amblyomma americanum in cats

Esafoxolaner, a purified enantiomer of afoxolaner with insecticidal and acaricidal properties, is combined with eprinomectin and praziquantel in NexGard® Combo, a novel topical endectoparasiticide product for cats. The efficacy of this novel formulation was assessed in two experimental studies against induced infestations with Amblyomma americanum, a tick species of major importance, highly prevalent in a large southeastern quarter of the United States. In each study, 10 cats were randomly allocated to a placebo control group and 10 cats to a novel formulation treated group. Infested cats were treated topically once at the minimum recommended dose. Both studies were designed to test curative efficacy on existing infestation, 72 h after treatment, and to test preventive efficacy, 72 h after subsequent weekly (Study #1) or fortnightly (Study #2) infestations for one month. For each infestation, all cats were infested with 50 unfed adult A. americanum. At each tick count, in both studies, at least 8 in 10 placebo control cats were infested with 13 (26%) or more live ticks, demonstrating adequate infestation throughout the studies. Curative efficacy of the novel formulation was 99% in both studies; preventive efficacy was 92% and 100% for at least one month.

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Efficacy of a novel topical combination of esafoxolaner, eprinomectin and praziquantel against Echinococcus multilocularis infections in cats

Parasite ◽

10.1051/parasite/2021025 ◽

2021 ◽

Vol 28 ◽

pp. 29

Author(s):

Joe Prullage ◽

Dwight Bowman ◽

Michael Ulrich ◽

Eric Tielemans

Keyword(s):

Echinococcus Multilocularis ◽

Experimental Studies ◽

The United States ◽

Treated Group ◽

Control Group ◽

Placebo Control ◽

The Novel ◽

Control Groups ◽

Geometric Means ◽

Placebo Control Group

NexGard® Combo, a novel topical endectoparasiticide formulation for cats combining esafoxolaner, eprinomectin and praziquantel, for the treatment of internal and external parasite infestations, including arthropods, nematodes and cestodes, was tested for efficacy against induced infections of Echinococcus multilocularis in cats, in two experimental studies. The two studies were performed in the United States with the same E. multilocularis isolate sourced locally. In each study, 20 cats were inoculated intra-gastrically with ~30,000 E. multilocularis protoscoleces three weeks before treatment, then ten cats were randomly allocated to a placebo control group or to the novel formulation treated group. Inoculated cats were treated topically once at the minimum recommended dose of the novel formulation, or with an identical volume of placebo. One week after treatment, cats were humanely euthanized for parasite recovery and count. The efficacy calculation was based on comparison of number of scoleces found in the control group and the novel formulation group. In the two control groups, E. multilocularis scoleces were found in five (range: 30–1025) and eight (range 2–345) cats, the geometric means inclusive of the ten cats per group were 8.9 and 28.8, respectively. In the two novel formulation-treated groups, none of the cats harbored any E. multilocularis scoleces, demonstrating 100% efficacy.

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Efficacy of a novel topical combination of esafoxolaner, eprinomectin and praziquantel against Rhipicephalus sanguineus in cats

Parasite ◽

10.1051/parasite/2021020 ◽

2021 ◽

Vol 28 ◽

pp. 24 ◽

Cited By ~ 3

Author(s):

Eric Tielemans ◽

Anthony Pfefferkorn ◽

Alta Viljoen

Keyword(s):

Experimental Study ◽

Tick Infestation ◽

Rhipicephalus Sanguineus ◽

Treated Group ◽

Recommended Dose ◽

Control Group ◽

Placebo Control ◽

Tick Count ◽

Placebo Control Group ◽

Preventive Efficacy

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Efficacy of a novel topical combination of esafoxolaner, eprinomectin and praziquantel against Ixodes ricinus and Ixodes scapularis in cats

Parasite ◽

10.1051/parasite/2021019 ◽

2021 ◽

Vol 28 ◽

pp. 23 ◽

Cited By ~ 3

Author(s):

Joe Prullage ◽

Anthony Pfefferkorn ◽

Martin Knaus ◽

Justin Frost ◽

Elizabeth Mitchell ◽

...

Keyword(s):

Ixodes Ricinus ◽

Ixodes Scapularis ◽

Experimental Studies ◽

Control Group ◽

Placebo Control ◽

The Novel ◽

Topical Formulation ◽

Arithmetic Means ◽

Pre Treatment ◽

Robust Evidence

Esafoxolaner is a purified enantiomer of afoxolaner with insecticidal and acaricidal properties. It is combined with eprinomectin and praziquantel in a novel topical endectoparasiticide formulation for cats. The efficacy of this novel formulation was evaluated in three Ixodes ricinus and two Ixodes scapularis experimental studies, with comparable designs. In each study, cats were randomly allocated, based on a pre-treatment tick infestation and count, to a placebo control group or a group treated with the minimum recommended dose of the novel formulation. Cats were infested two days before treatment and weekly thereafter. Immediate efficacy was evaluated 48 h after treatment; persistent efficacy was evaluated 48 h after new weekly infestations for at least one month after the treatment (in one of the studies, the first two weeks of persistent efficacy against I. ricinus were not tested). Efficacy was calculated at each timepoint by comparison of arithmetic means of live ticks found in the control and the treated groups. In the three studies targeting I. ricinus, immediate and persistent efficacies ranged between 91% and 100% for five weeks. In the two studies targeting I. scapularis, immediate and persistent efficacies ranged between 95% and 100%, and 98% and 100% for one month, respectively. These studies provide robust evidence of efficacy of the novel topical formulation of esafoxolaner, eprinomectin and praziquantel against experimental I. ricinus and I. scapularis infestations for at least one month in cats.

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Efficacy of a novel topical combination of esafoxolaner, eprinomectin and praziquantel against adult cat flea Ctenocephalides felis and flea egg production in cats

Parasite ◽

10.1051/parasite/2021017 ◽

2021 ◽

Vol 28 ◽

pp. 21 ◽

Cited By ~ 2

Author(s):

Eric Tielemans ◽

Prescillia Buellet ◽

David Young ◽

Alta Viljoen ◽

Julian Liebenberg ◽

...

Keyword(s):

Egg Production ◽

Experimental Studies ◽

Ctenocephalides Felis ◽

Control Group ◽

Placebo Control ◽

Immature Stages ◽

The Novel ◽

Cat Flea ◽

Larval Hatching ◽

Adult Cat

Esafoxolaner, a purified enantiomer of afoxolaner with insecticidal and acaricidal properties, is combined with eprinomectin and praziquantel in NexGard® Combo, a novel topical endectoparasiticide formulation for cats. The efficacy of this novel formulation against adult and immature stages of Ctenocephalides felis fleas was tested in four experimental studies. Two studies were designed to test adulticide efficacy, one to test inhibition of immature stages, and one to test both adulticide efficacy and inhibition of immature stages. In each study, cats were randomly allocated to a placebo control group or to a novel formulation group treated once at the minimum recommended dose. Cats were experimentally infested weekly for one to two months with unfed C. felis originating from North America or Europe. For adulticide efficacy evaluations, live fleas were counted 24 h after treatment and after subsequent weekly infestations. For immature stages, flea eggs were collected and counted weekly for evaluation of egg production inhibition and incubated for larval hatching evaluation. In the three studies testing adult fleas, curative efficacies, 24 h after treatment, were 92.1%, 98.3% and 99.7%; preventive weekly efficacies, 24 h after weekly infestations, remained higher than 95.5% for at least one month. In the two studies testing immature stages, egg production and larval hatching was significantly reduced for at least one month. These studies provide robust evidence of efficacy of the novel formulation against experimental adult flea infestations and for the prevention of environmental contamination by immature flea stages, for at least one month.

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Subcutaneous Injection of Nitroglycerin at the Radial Artery Puncture Site Reduces the Risk of Early Radial Artery Occlusion After Transradial Coronary Catheterization

Circulation Cardiovascular Interventions ◽

10.1161/circinterventions.118.006571 ◽

2018 ◽

Vol 11 (7) ◽

Cited By ~ 12

Author(s):

Yequn Chen ◽

Zhiquan Ke ◽

Jiaxin Xiao ◽

Mengyue Lin ◽

Xiru Huang ◽

...

Keyword(s):

Radial Artery ◽

Subcutaneous Injection ◽

Treated Group ◽

Artery Occlusion ◽

Control Group ◽

Placebo Control ◽

Puncture Site ◽

Coronary Catheterization ◽

Placebo Control Group ◽

Radial Artery Occlusion

Background: Transradial coronary catheterization is widely used as a diagnostic or interventional procedure for coronary disease. However, it can lead to adverse complications, such as radial artery occlusion. We sought to determine whether preprocedural injection of nitroglycerin at the radial artery puncture site reduces radial artery occlusion. Methods and Results: A total of 188 patients undergoing transradial coronary catheterization were randomized in a single-blind fashion to receive subcutaneous injection of 0.5 mL 0.1% nitroglycerin or a placebo at the radial artery puncture site. The participants underwent ultrasound examinations of the radial artery before and at 24 hours after the procedure. Of the 188 patients enrolled, 182 completed the study, as the procedure failed in 2 participants in the nitroglycerin-treated group and 4 in the placebo group. Baseline demographic and clinical characteristics were similar between 2 groups. Comparing the radial artery diameters before and after the operation, there was a statistically significant increase in the nitroglycerin-treated group (2.48±0.45 versus 2.45±0.46 mm; P =0.003) but a decrease in the placebo control group (2.41±0.50 versus 2.46±0.49 mm; P <0.001). Importantly, the incidence of radial arterial occlusion was substantially lower in the nitroglycerin-treated group than in the placebo control group (5.4% versus 14.4%; P =0.04). There was not significant difference in other complications (forearm hematoma and radial artery pseudoaneurysm, respectively), and there was no incidence of cause hypotension or an intolerable headache. Conclusions: Subcutaneous injection of nitroglycerin at the radial artery puncture site dilates the radial artery and reduces the incidence of early radial artery occlusion post-catheterization. Clinical Trial Registration: URL: https://www.chictr.org.cn . Unique identifier: ChiCTR-IPR-15006559.

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Comparative preventive efficacy of ProHeart® 12, Heartgard® Plus and Interceptor® Plus against a macrocyclic lactone-resistant strain (JYD-34) of heartworm (Dirofilaria immitis) in dogs

Parasites & Vectors ◽

10.1186/s13071-021-04708-3 ◽

2021 ◽

Vol 14 (1) ◽

Author(s):

Tom L. McTier ◽

Susan Holzmer ◽

Kristina Kryda ◽

Sean Mahabir ◽

John W. McCall ◽

...

Keyword(s):

Resistant Strain ◽

Dirofilaria Immitis ◽

Macrocyclic Lactone ◽

Geometric Mean ◽

Treated Group ◽

Control Group ◽

Placebo Control ◽

Worm Count ◽

Preventive Efficacy ◽

The Mean

Abstract Background The current studies compared ProHeart® 12, Heartgard® Plus and Interceptor® Plus for preventive efficacy against JYD-34, a macrocyclic lactone (ML)-resistant strain of Dirofilaria immitis in dogs. Methods In two studies, each using 24 adult beagles, dogs were allocated to four treatment groups (n = 6): placebo-treated control; ProHeart 12 as per label (0.5 mg/kg moxidectin); Heartgard Plus (HGP) as per label (minimum 6 µg/kg ivermectin); and Interceptor Plus (INP) as per label (minimum 0.5 mg/kg milbemycin oxime). In both studies, ProHeart 12 was administered as a single subcutaneous dose on day 0, and HGP and INP were administered orally on days 0, 30, 60, 90, 120 and 150. In Studies 1 and 2, dogs were inoculated with 50 third-stage heartworm larvae (JYD-34 strain) on days −30 and 165, respectively. In Study 2, treatment for both HGP and INP was continued on days 180, 210, 240, 270, 300 and 330. Adult heartworm recoveries were performed on day 185 in Study 1 and on day 360 in Study 2. Results In Studies 1 and 2, all placebo-treated dogs developed adult heartworm infections (geometric mean, 29.9 and 34.9 worms/dog, respectively). A single dose of ProHeart 12 was 100% effective in preventing the development of adult JYD-34 heartworms when treatment was initiated 30 days after heartworm inoculation, while six consecutive monthly doses of HGP and INP were only 10.5% and 14.6% effective, respectively. The mean worm count for the ProHeart 12-treated group was significantly lower (P < 0.0001) than that for the placebo control, HGP- and INP-treated groups. In Study 2, the dogs treated with ProHeart 12 had an efficacy of 98.3%. All dogs treated with HGP and INP for 12 consecutive months had adult heartworms with efficacies of 37.7% and 34.9%, respectively. The mean worm count for the ProHeart 12-treated dogs was significantly lower (P < 0.0001) than those for the control group, HGP- and INP-treated groups. Conclusions A single administration of ProHeart 12 was 98–100% effective in preventing the development of the ML-resistant JYD-34 heartworm strain and was significantly better than multiple consecutive monthly doses of either Heartgard Plus or Interceptor Plus in both studies. Graphic Abstract

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ESTIMATING EFFECTS OF SYSTEMATIC TREATMENT ON RENAL FAILURE AND DEATH WITHOUT A PARALLEL PLACEBO CONTROL GROUP

Nephrology ◽

10.1046/j.1440-1797.2000.abs122.x ◽

2000 ◽

Vol 5 (3) ◽

pp. A97-A97

Author(s):

Hoy We ◽

Baker P ◽

Wang Z ◽

Cass A ◽

Mathews Jd ◽

...

Keyword(s):

Renal Failure ◽

Control Group ◽

Placebo Control ◽

Systematic Treatment ◽

Placebo Control Group

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Protective Effectiveness of Long-Lasting Permethrin Impregnated Clothing Against Tick Bites in an Endemic Lyme Disease Setting: A Randomized Control Trial Among Outdoor Workers

Journal of Medical Entomology ◽

10.1093/jme/tjaa061 ◽

2020 ◽

Vol 57 (5) ◽

pp. 1532-1538

Author(s):

Cedar Mitchell ◽

Megan Dyer ◽

Feng-Chang Lin ◽

Natalie Bowman ◽

Thomas Mather ◽

...

Keyword(s):

United States ◽

Rhode Island ◽

The United States ◽

Amblyomma Americanum ◽

Adverse Outcomes ◽

Control Group ◽

Tick Bites ◽

Outdoor Workers ◽

Significant Difference ◽

Protective Effectiveness

Abstract Tick-borne diseases are a growing threat to public health in the United States, especially among outdoor workers who experience high occupational exposure to ticks. Long-lasting permethrin-impregnated clothing has demonstrated high initial protection against bites from blacklegged ticks, Ixodes scapularis Say (Acari: Ixodidae), in laboratory settings, and sustained protection against bites from the lone star tick, Amblyomma americanum (L.) (Acari: Ixodidae), in field tests. However, long-lasting permethrin impregnation of clothing has not been field tested among outdoor workers who are frequently exposed to blacklegged ticks. We conducted a 2-yr randomized, placebo-controlled, double-blinded trial among 82 outdoor workers in Rhode Island and southern Massachusetts. Participants in the treatment arm wore factory-impregnated permethrin clothing, and the control group wore sham-treated clothing. Outdoor working hours, tick encounters, and bites were recorded weekly to assess protective effectiveness of long-lasting permethrin-impregnated garments. Factory-impregnated clothing significantly reduced tick bites by 65% in the first study year and by 50% in the second year for a 2-yr protective effect of 58%. No significant difference in other tick bite prevention method utilization occurred between treatment and control groups, and no treatment-related adverse outcomes were reported. Factory permethrin impregnation of clothing is safe and effective for the prevention of tick bites among outdoor workers whose primary exposure is to blacklegged ticks in the northeastern United States.

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Efficacy and Safety of Ejiao (Asini Corii Colla) in Women With Blood Deficient Symptoms: A Randomized, Double-Blind, and Placebo-Controlled Clinical Trial

Frontiers in Pharmacology ◽

10.3389/fphar.2021.718154 ◽

2021 ◽

Vol 12 ◽

Author(s):

Li Zhang ◽

Zhongju Xu ◽

Tao Jiang ◽

Jialu Zhang ◽

Pinxian Huang ◽

...

Keyword(s):

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Blood Cell ◽

Control Group ◽

Placebo Control ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

Double Blind ◽

Placebo Control Group ◽

Sf 36

Equus asinus L [Equidae; Asini Corii Colla] (donkey-hide gelatin, Ejiao), a well-known traditional Chinese medicine, has been widely used to nourish the blood, especially for women. The aim of this study was to assess the efficacy and safety of Ejiao in blood-deficient patients. A total of 210 participants were recruited and randomly allocated into the placebo control group and Ejiao-treated group (6 g/day). The primary outcomes on the efficacy of Ejiao included traditional Chinese medicine symptom scores, blood indicators, and SF-36. The secondary outcomes were changes in fireness and safety evaluation. Results showed that Ejiao treatment for 8 weeks had significantly improved dizziness symptoms. Among the tested 24 blood biochemical parameters, the hematocrit and red blood cell numbers decreased in the placebo control group, but decreased significantly less in the Ejiao treatment group. The white blood cell and neutrophil counts increased in the Ejiao group but were within the normal range. In addition, the quality of life improved as the scores in SF-36 domains were significantly higher in the Ejiao group. At the same time, there was no significant change in the fire–heat symptoms score or other safety parameters. Considering all these, our study showed that Ejiao has a promising effect in women suffering from blood deficiency without obvious adverse effects.

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Efficacy of a novel topical combination of esafoxolaner, eprinomectin and praziquantel against fleas in cats, under field conditions

Parasite ◽

10.1051/parasite/2021018 ◽

2021 ◽

Vol 28 ◽

pp. 22 ◽

Cited By ~ 2

Author(s):

Eric Tielemans ◽

Tomoko Otsuki ◽

Tara Cheesman ◽

Fiona Selmes ◽

Anthony Pfefferkorn ◽

...

Keyword(s):

United States ◽

Field Studies ◽

The United States ◽

Positive Control ◽

Control Group ◽

The Novel ◽

Domestic Cats ◽

Label Dose ◽

Treatment Tolerance ◽

Significant Health

Esafoxolaner is a purified afoxolaner enantiomer with insecticidal and acaricidal properties. It is combined with eprinomectin and praziquantel, nematodicidal and cestodicidal compounds, in a novel topical endectoparasiticide formulation for cats. This novel formulation was tested in four field studies, in the United States, Europe, Japan and Australia. In all studies, naturally flea-infested domestic cats were treated with the novel formulation at the label dose and conditions of use. The main objective, identical in the four studies, was to assess efficacy on fleas, based on comparison of mean number of fleas found on infested cats before and one month after treatment. Tolerance to the product was also evaluated in the four studies. Otherwise, the studies had some differences in their design and secondary objectives, for example testing for a reduction in flea infestation-related cutaneous signs, testing of one treatment or of three monthly treatments, and use of a positive control group. In the four studies, a total of 307 cats were treated with the novel formulation. The reduction of fleas one month after treatment was 97.7%, 98.8%, 100% and 99.7% in the United States, Europe, Japan and Australia, respectively. There were no significant health abnormalities attributed to treatment in any of the studies.

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