PDF(Pubmed)
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.
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.
摘要：
背景：关键的随机化，失明,阳性对照,多中心,进行了欧洲现场研究，以评估口服给予自然感染跳蚤和/或蜱的客户拥有的狗的新型lotilaner和milbemycin肟（Credelio®Plus）组合片剂的有效性和安全性。
方法：在本领域研究中，在第0天,有跳蚤或蜱出没的狗的家庭被纳入研究,以提供蜱或跳蚤出没队列的数据.家庭以2：1的比例随机接受组合研究产品(IP，CredelioPlus®片剂）或对照产品（CP：NexgardSpectra®片剂）。狗每4周一次接受IP（跳蚤队列n=135；tick队列：n=147）或CP（跳蚤队列：n=67；tick队列：n=74），共3次，剂量率为20.0-41.5mg/kg体重lotilaner和0.75-1.53mg/kg体重米尔比霉素肟（IP）或推荐（CP）。通过将在每个评估的治疗后时间点的个体狗跳蚤和蜱计数与它们各自的基线(治疗前)侵染进行比较来计算减少百分比。在进行跳蚤计数的当天，在跳蚤过敏的狗中评估了跳蚤过敏性皮炎（FAD）的临床体征的消退。
结果：连续3个月治疗后，CredelioPlus®对Ctenocephalidesfelis的跳蚤有效性为100％，C.犬科动物和Pulexirritans。在相同的时间范围内，CredelioPlus®的滴答效果对蓖麻Ixodes为99.3％，对血根虫（s.l.）为100％。连续三个月治疗后，CP的跳蚤有效性对C.felis为100％，C.犬类和P.irritans。在相同的时间范围内，CP的滴答效力对蓖麻的为99.8％，对血门的为100％。根据本领域研究中所有治疗犬的安全性评估,CredelioPlus®具有良好的耐受性。在两个治疗组中,总FAD评分从基线降低。
结论：这项关键的欧洲领域研究表明，对自然感染跳蚤和/或蜱的狗口服洛替兰纳和米尔贝霉素肟（CredelioPlus®）的组合具有优异的有效性和安全性。
方法：在本领域研究中，在第0天,有跳蚤或蜱出没的狗的家庭被纳入研究,以提供蜱或跳蚤出没队列的数据.家庭以2：1的比例随机接受组合研究产品(IP，CredelioPlus®片剂）或对照产品（CP：NexgardSpectra®片剂）。狗每4周一次接受IP（跳蚤队列n=135；tick队列：n=147）或CP（跳蚤队列：n=67；tick队列：n=74），共3次，剂量率为20.0-41.5mg/kg体重lotilaner和0.75-1.53mg/kg体重米尔比霉素肟（IP）或推荐（CP）。通过将在每个评估的治疗后时间点的个体狗跳蚤和蜱计数与它们各自的基线(治疗前)侵染进行比较来计算减少百分比。在进行跳蚤计数的当天，在跳蚤过敏的狗中评估了跳蚤过敏性皮炎（FAD）的临床体征的消退。
结果：连续3个月治疗后，CredelioPlus®对Ctenocephalidesfelis的跳蚤有效性为100％，C.犬科动物和Pulexirritans。在相同的时间范围内，CredelioPlus®的滴答效果对蓖麻Ixodes为99.3％，对血根虫（s.l.）为100％。连续三个月治疗后，CP的跳蚤有效性对C.felis为100％，C.犬类和P.irritans。在相同的时间范围内，CP的滴答效力对蓖麻的为99.8％，对血门的为100％。根据本领域研究中所有治疗犬的安全性评估,CredelioPlus®具有良好的耐受性。在两个治疗组中,总FAD评分从基线降低。
结论：这项关键的欧洲领域研究表明，对自然感染跳蚤和/或蜱的狗口服洛替兰纳和米尔贝霉素肟（CredelioPlus®）的组合具有优异的有效性和安全性。
