Field efficacy and safety of Felpreva® (tigolaner, emodepside and praziquantel) spot-on for the treatment of natural ear mite infestations (Otodectes cynotis) and notoedric mange (Notoedres cati) in cats.

The miticide efficacy of a single treatment with Felpreva® (tigolaner, emodepside and praziquantel) spot-on solution for cats was evaluated in two European field studies. One study was conducted in cats naturally infested with Otodectes cynotis. The other study was conducted in cats naturally infested with Notoedres cati. In both studies, the presence of viable mites was confirmed prior to treatment (Day -1/Day 0) and re-evaluated on Day 14 (O. cynotis study) and on Day 28 (both studies). Efficacy was calculated based on the number of viable mites found after treatment. In the O. cynotis study, the primary criterion was the percentage of mite-free cats after treatment with Felpreva® compared to a sarolaner/selamectin combination (Stronghold® Plus, Zoetis) as a positive control. In the N. cati study, the primary criterion was the difference between arithmetic mean mite counts of cats treated with Felpreva® and cats treated with a placebo formulation (solketal). Secondary criteria in both studies were changes in clinical lesion scores after treatment. In both studies, all Felpreva®-treated cats were mite-free (100% parasitological cure) on Day 28, 4 weeks after treatment. Signs of mange on Day 28 were clinically improved in all O. cynotis-infested cats (100%) and clinically cured in all N. cati-infested cats (100%). There were no records of any adverse events or application site reactions in Felpreva®-treated cats.

Efficacy of Felpreva®, a new spot-on formulation containing tigolaner, emodepside and praziquantel, applied as a single application to cats artificially infested with ear mites (Otodectes cynotis).

The efficacy of Felpreva® (Vetoquinol), a new spot-on application containing the novel acaricide and insecticide tigolaner in combination with emodepside and praziquantel, was evaluated in cats artificially infested with ear mites (Otodectes cynotis). A total of three pivotal dose confirmation studies were conducted, two of them designed as non-interference studies. Cats were artificially infested with O. cynotis mites and randomly allocated into groups of 8 cats based on pre-treatment mite counts. Cats were treated once on Day 0, either with Felpreva® (14.5 â€‹mg/kg tigolaner, 3 â€‹mg/kg emodepside and 12 â€‹mg/kg praziquantel) or with placebo. Studies with a non-interference design included two additional groups of cats, treated with Profender® spot-on solution (Vetoquinol) (3 â€‹mg/kg emodepside and 12 â€‹mg/kg praziquantel) and tigolaner as a mono product (14.5 â€‹mg/kg tigolaner). Efficacy was evaluated on Day 28/Day 30 based on total live mite counts after ear flushing. Efficacy was claimed when: (i) at least six control cats per group were adequately infested with mites; (ii) calculated efficacy was ≥ 90% based on geometric mean mite counts; and (iii) the difference in mite counts between Felpreva®-treated cats and control cats was statistically significant (P â€‹≤ â€‹0.05). In two of the three studies, Felpreva®-treated cats were mite-free (100% efficacy) on Day 28/Day 30 and almost full efficacy (99.6%) was seen in the third study. The difference in mite counts between Felpreva®-treated cats and control cats was significant (P â€‹< â€‹0.0001) in all three studies. All control cats were adequately infested in all three studies. The efficacy of Felpreva® against ear mite (Otodectes cynotis) infection in cats was confirmed.

Immediate and long-term efficacy of Felpreva®, a new spot-on formulation containing tigolaner, emodepside and praziquantel, applied as a single application to cats artificially infested with the cat flea Ctenocephalides felis.

Five studies (two dose determination, two dose confirmation, and one speed of flea kill study) were conducted to assess the immediate (therapeutic) efficacy and long-term persistent (preventive) efficacy of a single spot-on application containing the novel acaricide and insecticide tigolaner in combination with emodepside and praziquantel (Felpreva®, Vetoquinol S.A. Lure, France) applied to cats artificially infested with Ctenocephalides felis. Eight cats per group were randomly allocated to 0, 1×, 1.3× and 2× of the minimum dose (14.5 â€‹mg/kg body weight) of tigolaner (dose determination studies) or randomly allocated to 0 and 1× of the dosage (dose confirmation studies). Onset of efficacy was assessed in a speed of flea kill study on an existing flea infestation 8, 12 and 24 â€‹h after treatment and reassessed after monthly flea reinfestation until 13 weeks post-treatment. Efficacy was calculated according to the Abbott formula using arithmetic means. Efficacy was claimed when (i) control groups were adequately infested (flea retention ≥ 50%) at each time-point in the studies; (ii) flea counts in treated groups were significantly lower (P â€‹≤ â€‹0.05) than flea counts in control groups; and (iii) calculated efficacy was ≥ 90% (speed of flea kill study) and ≥ 95% (dose determination and dose confirmation studies). Tigolaner at 14.5 â€‹mg/kg body weight was 100% effective against fleas on Day 1 (immediate, therapeutic efficacy) in both, dose determination and dose confirmation studies. The long-term persistent efficacy in week 13 ranged between 96.3% and 100%. Fleas were rapidly killed within 12 â€‹h after treatment (100% flea reduction, immediate efficacy). New flea infestations were successfully prevented for 8 weeks (98.9-100% flea reduction) within 8 â€‹h after reinfestation, and at week 13 (96.3% flea reduction) within 24 â€‹h after reinfestation.

Determination of the effect of collars containing 10% w/w imidacloprid and 4.5% w/w flumethrin (Seresto®) on the incidence of Leishmania and other canine vector-borne pathogen infections in Greece.

BACKGROUND: The objective of this field study was to assess the effect of treating a considerable portion of a dog population naturally exposed to canine vector-borne pathogens (CVBPs) in endemic areas with a 10% w/w imidacloprid/4.5% w/w flumethrin collar (Seresto®) on the transmission of CVBPs and the resulting incidence of infection. METHODS: A total of 479 dogs from two sites were enrolled in the study. Collars were placed on all dogs continuously for 21 months, with replacement of the collar every 7 months. All dogs were examined, including body weight and blood/conjunctival swab collections, every 7 months. Serum samples were analysed for the presence of antibodies against Leishmania infantum, Ehrlichia canis and Anaplasma phagocytophilum. PCR assays were also performed on blood samples and conjunctival swab collected from the dogs for the presence of L. infantum, and on blood samples only for the presence of Ehrlichia spp. and Anaplasma spp. Sand flies were collected, identified to species level and molecularly tested for L. infantum throughout two vector activity seasons. RESULTS: The results showed that the Seresto collar was safe with continuous use. At study inclusion, 419, 370 and 453 dogs tested negative for L. infantum, Ehrlichia spp. and Anaplasma spp., respectively (353 dogs tested negative for any pathogen). Overall, 90.2% of the dogs were protected from L. infantum infection on both sites combined. The entomological survey confirmed the presence of competent vectors of L. infantum at all monitored locations, namely the sand flies Phlebotomus neglectus and Phlebotomus tobbi, both of which are regarded as the most important competent vectors in the Mediterranean basin. All captured sand flies tested negative for L. infantum. Protection against ticks and fleas was high, with only two dogs showing a low number of ticks and seven dogs having low numbers of fleas at single evaluation time points. Across the entire study population, a number of dogs became infected with tick-transmitted pathogens, but prevention of transmission was 93% for E. canis and 87.2% for Anaplasma spp. when all cases from both sites were combined. CONCLUSIONS: The Seresto® (10% w/w imidacloprid/4.5% w/w flumethrin) collar significantly reduced the risk of CVBP transmission when compared to previously observed incidences of CVBP infections in two highly endemic areas under field conditions.

Multicenter randomized, and blinded European field study evaluating the efficacy and safety of Felpreva®, a novel spot-on formulation containing emodepside, praziquantel and tigolaner, in treating cats naturally infested with fleas and/or ticks.

The present field study evaluated the safety and 3-month preventive efficacy of a novel spot-on endectocide containing emodepside 2.04% w/v, praziquantel 8.14% w/v and tigolaner 9.79% w/v (Felpreva®, Vetoquinol) when administered at the intended commercial dose of 0.15 ml/kg body weight to privately owned cats infested by fleas (Ctenocephalides felis) and/or ticks (Ixodes ricinus, Ixodes hexagonus, Rhipicephalus spp.). The efficacy of Felpreva® to reduce the clinical signs associated with flea allergy dermatitis was also evaluated. A total of 326 cats, i.e. 120 and 206 infested by ticks and fleas respectively, from 16 different sites located in Hungary and Portugal were included on Day 0 and allocated in two Groups at a ratio of 2:1 (T1:T2). Cats of T1 were treated with Felpreva®, while cats of T2 were dosed with a commercial Control Product (Bravecto®, MSD Animal Health) licensed for the same indications. Of the 120 tick-infested cats, 79 and 41 were treated with Felpreva® and Bravecto® respectively, while of the 206 flea-infested cats, 139 were treated with Felpreva® and 67 with Bravecto®. Cats were physically examined on Days 7, 28, 56, 75 and 90; when present, fleas and ticks were counted and collected. Efficacy evaluation was based on the mean percent reduction of live parasite counts for each of five visits versus the pre-treatment count. Percent reductions of live flea and tick counts over all post-baseline periods were 99.74% (T1) versus 98.56% (T2) and 97.50% (T1) versus 98.65% (T2), respectively. Non-inferiority for the Felpreva® compared with the Bravecto® treated group was statistically demonstrated for both fleas and ticks. Three adverse events were observed and considered unlikely related to the treatment. These results show that the new topical combination product Felpreva® is safe and highly efficacious in treating flea and tick infections in cats for at least three months (90 days) with a single administration. In 16 cats that were identified with flea allergy dermatitis, the clinical signs of flea allergy dermatitis improved following treatment in both groups.

Multicenter randomized, and blinded European field study evaluating the efficacy and safety of Felpreva®, a novel spot-on formulation containing tigolaner, emodepside and praziquantel, in treating cats with mixed infection with intestinal nematodes, cestodes and/or lungworms.

This paper describes a multicentric field study which has evaluated the safety and efficacy of a novel spot on formulation containing emodepside 2.04% w/v, praziquantel 8.14% w/v and tigolaner 9.79% w/v (Felpreva®, Vetoquinol) when administered at the intended commercial dose of 0.15 ml/kg body weight to privately owned cats infected with major intestinal nematodes (Toxocara cati, Toxascaris leonina, Ancylostoma tubaeforme, Uncinaria stenocephala) and/or cestodes (Dipylidium caninum, Taenia taeniaeformis) and/or lungworms (Aelurostrongylus abstrusus, Troglostrongylus brevior). A total of 219 cats from 26 veterinary clinics located in Albania, Greece, Hungary, Italy and Portugal were included in the study. Feces from the cats were examined on a single occasion between Study Day -7 and Day 0 (baseline) and post-treatment (i) twice between Day 7 and Day 14 (± 2) (for intestinal helminths) or (ii) twice between Day 21 (± 2) and Day 28 (± 2) (for lungworms). Cats were allocated into two groups at a ratio of 2:1 (Felpreva®: Profender®, i.e. a commercial control product containing emodepside and praziquantel). Cats infected with intestinal helminths were treated once on Day 0 (i) with Felpreva® (Group 1) or (ii) with Profender® (Group 2). Animals infected with lungworms received a second treatment with Profender® on Day 14 (± 2) regardless of group allocation. Faecal egg or larval count reduction for Felpreva® was 97.47% for intestinal nematodes and 96.80% for lungworms. No cats infected with cestodes at baseline resulted positive after treatment with Felpreva®. However, the low number of cats (n = 10) did not allow for a statistical analysis to be performed. Non-inferiority of Felpreva® compared to Profender® was statistically demonstrated for all target intestinal and respiratory parasites. No adverse events nor application site reactions were observed. These results show that the new topical combination product Felpreva® is highly safe and efficacious in treating infections caused by major species of feline intestinal nematodes, cestodes and lungworms under field conditions.

Efficacy of two topical combinations containing emodepside plus praziquantel, and emodepside plus praziquantel plus tigolaner, for the treatment of troglostrongylosis in experimentally infected cats.

Feline troglostrongylosis caused by Troglostrongylus brevior is increasingly reported in European countries. Although the disease can be severe and potentially life-threatening, especially in kittens and young cats, effective treatment options are still limited. Two administrations of emodepside 2 weeks apart have shown promising results for the treatment of T. brevior infection in single cases and in a field trial. Therefore, the present study has been conducted to evaluate the efficacy of two spot-on combinations containing emodepside (i.e. 2.14% w/v emodepside and 8.58% w/v praziquantel - Profender®, and 2.04% w/v emodepside, 8.14% w/v praziquantel and 9.79% w/v tigolaner - Felpreva®) in the treatment of troglostrongylosis under experimental conditions. Twenty-four cats were experimentally infected with T. brevior and randomly assigned to one of three groups of eight cats each, i.e. (i) Group 1 (G1) left untreated, (ii) Group 2 (G2) receiving Profender® on Days 28 and 44, and (iii) Group 3 (G3) receiving Felpreva® on Day 28 and Profender® on Day 44. Doses corresponded to the minimum effective dose of 0.140 and 0.148 ml/kg body weight, for Profender® and Felpreva®, respectively. The primary efficacy criterion was the number of viable adult T. brevior counted at necropsy conducted between Days 69 and 72. The fecal shedding of first-stage larvae (L1) was also assessed. L1 of T. brevior were detected in samples from all cats within 20 days post-infection. At necropsy, 4 of 8 G1 cats harbored adult T. brevior, while no adult T. brevior worms or other development stages were recovered from any of the G2 and G3 cats. The primary efficacy criterion was not evaluated as the worm counts in G1 did not meet VICH guideline requirements. After the first treatment (Day 28), most G2 and G3 cats were negative at the Baermann examination. After the second treatment (Day 44), L1 were found in two cats from G2 on Day 49 and in one G3 cat on Day 51. No adverse events occurred in G2 and G3 cats. These results indicate that two applications of emodepside spot-on given 2 weeks apart represent a safe and efficacious treatment regime against troglostrongylosis.

Efficacy of a spot-on combination containing 10% w/v imidacloprid and 1% w/v moxidectin for the treatment of troglostrongylosis in experimentally infected cats.

BACKGROUND: Parasitic bronchopneumonia in domestic cats in Europe, which can manifest with moderate to severe clinical signs, is frequently caused by Troglostrongylus brevior. Data on epizootiological and clinical relevance of cat troglostrongylosis have been published in the last decade but treatment options are still limited. Promising effectiveness data have been generated from clinical cases and field trials for a spot-on formulation containing 1% w/v moxidectin and 10% w/v imidacloprid (Advocate®, Elanco Animal Health). Therefore, two studies have been conducted to confirm under experimental conditions the efficacy of moxidectin 1% contained in Advocate® for the treatment of cat troglostrongylosis. METHODS: Sixteen and 20 cats experimentally infected with T. brevior were included in two separate studies, i.e., Study 1 and 2, respectively. Cats were infected with T. brevior third-stage larvae via gastric tube. In both studies cats were randomized to untreated (control, Group 1) and treatment (Group 2) groups. In Study 1 and Study 2, the two groups comprised eight and 10 cats each. Treated cats received Advocate® spot-on twice at a 4-week interval. The primary efficacy criterion was the number of viable adult T. brevior counted at necropsy. Throughout the trial, the fecal shedding of first-stage larvae (L1) was assessed in treated and untreated control cats. RESULTS: The experimental model was successful in both studies, as all cats started shedding T. brevior L1 within 25 days post-infection. At necropsy, T. brevior adults were found in 4/8 and 4/10 cats of the control groups in Study 1 and 2, respectively, while none of the treated cats harbored adult worms. The necropsy worm counts in controls did not meet relevant guideline requirements for adequacy of infection, with fewer than six infected cats in the control groups, thus limiting conclusions on treatment efficacy. The fact that 6/8 and 8/10 control cats in Study 1 and 2, respectively, shed L1 up to necropsy while larval shedding ceased in all treated animals after the first treatment provides supporting evidence on the level of efficacy. No remarkable adverse events were recorded in the two studies. CONCLUSION: These results indicate that Advocate® spot-on is a safe and effective option for treating cats infected by T. brevior.