Long-term and acute safety of a novel orally administered combination drug product containing milbemycin oxime and lotilaner (Credelio
Canine
Credelio® Plus
Lotilaner
Milbemycin oxime
Safety
Journal
Parasites & vectors
ISSN: 1756-3305
Titre abrégé: Parasit Vectors
Pays: England
ID NLM: 101462774
Informations de publication
Date de publication:
28 May 2021
28 May 2021
Historique:
received:
03
02
2021
accepted:
03
05
2021
entrez:
28
5
2021
pubmed:
29
5
2021
medline:
27
10
2021
Statut:
epublish
Résumé
The combination of milbemycin oxime (MO) and lotilaner (Credelio The objectives of these studies were to determine the long-term and acute safety of MO and lotilaner flavored chewable tablets in healthy dogs. All three studies were randomized, blinded, parallel-group design studies in healthy Beagle dogs. In each of the two long-term studies, 32 dogs were randomized among four groups to untreated controls or to treated groups at target doses of 1X, 3X, or 5X. Treatment was administered on seven (adult dogs) or nine (juvenile dogs) occasions with dosing every 4 weeks. In the acute study, 48 dogs were randomized among four groups to untreated controls or to treated groups at 1X, 3X, or 6X. In all three studies, the control group was administered placebo tablets. All dogs were fed 30 to 45 min prior to treatment and the assessment of safety was based on health observations, complete physical/neurological examinations, and food consumption. For the long-term safety studies, safety assessments also included clinical pathology evaluations (hematology, clinical chemistry and urinalysis), body weight, pharmacokinetic blood collections, and macroscopic and microscopic examinations of collected tissues. MO and lotilaner did not induce any treatment-related adverse effects based on health observations, physical/neurological examinations, or food consumption in the long-term or acute studies. Additionally, in the long-term studies, MO and lotilaner did not induce any treatment-related effects on clinical pathology, body weight, and macroscopic and microscopic examinations. These three studies demonstrate that Credelio
Sections du résumé
BACKGROUND
BACKGROUND
The combination of milbemycin oxime (MO) and lotilaner (Credelio
METHODS
METHODS
The objectives of these studies were to determine the long-term and acute safety of MO and lotilaner flavored chewable tablets in healthy dogs. All three studies were randomized, blinded, parallel-group design studies in healthy Beagle dogs. In each of the two long-term studies, 32 dogs were randomized among four groups to untreated controls or to treated groups at target doses of 1X, 3X, or 5X. Treatment was administered on seven (adult dogs) or nine (juvenile dogs) occasions with dosing every 4 weeks. In the acute study, 48 dogs were randomized among four groups to untreated controls or to treated groups at 1X, 3X, or 6X. In all three studies, the control group was administered placebo tablets. All dogs were fed 30 to 45 min prior to treatment and the assessment of safety was based on health observations, complete physical/neurological examinations, and food consumption. For the long-term safety studies, safety assessments also included clinical pathology evaluations (hematology, clinical chemistry and urinalysis), body weight, pharmacokinetic blood collections, and macroscopic and microscopic examinations of collected tissues.
RESULTS
RESULTS
MO and lotilaner did not induce any treatment-related adverse effects based on health observations, physical/neurological examinations, or food consumption in the long-term or acute studies. Additionally, in the long-term studies, MO and lotilaner did not induce any treatment-related effects on clinical pathology, body weight, and macroscopic and microscopic examinations.
CONCLUSIONS
CONCLUSIONS
These three studies demonstrate that Credelio
Identifiants
pubmed: 34044853
doi: 10.1186/s13071-021-04760-z
pii: 10.1186/s13071-021-04760-z
pmc: PMC8161958
doi:
Substances chimiques
Drug Combinations
0
Insecticides
0
lotilaner
0
Macrolides
0
milbemycin oxime
0502PUN0GT
Oxazoles
0
Thiophenes
0
Types de publication
Journal Article
Randomized Controlled Trial, Veterinary
Langues
eng
Sous-ensembles de citation
IM
Pagination
285Commentaires et corrections
Type : CommentIn
Références
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