Efficacy and safety of enflicoxib for treatment of canine osteoarthritis: A 6-week randomised, controlled, blind, multicentre clinical trial
Salichs, M. et al (2021) Efficacy and safety of enflicoxib for treatment of canine osteoarthritis: a 6-week randomised, controlled, blind, multicentre clinical trial. Veterinary Record
The aim of this prospective randomised controlled trial was to confirm the safety and efficacy of enflicoxib for the treatment of naturally occurring osteoarthritis (OA) in dogs. The study, which was carried out at 28 veterinary practices located throughout Spain and France, was funded by Ecuphar, manufacturers of enflicoxib and two of the authors work for Ecuphar.
Dogs with clinical signs of pain and lameness for at least three weeks and radiographic evidence of OA in at least one joint were eligible for inclusion. The study period lasted for six months. Dogs were randomly allocated to one of four treatment groups: enflicoxib at either 4 or 2 mg/kg; placebo, or mavacoxib 2 mg/kg. Enflicoxib and placebo were administered weekly from day 0 to day 35, mavacoxib was administered on day 0 and day 14 with that group receiving placebo on days 7, 21, 28 and 35 to ensure blinding.
The severity of the clinical signs of OA were assessed by both the veterinarian and owner at weekly intervals. The veterinarian assessment used weighted numerical rating scales that assessed posture whilst standing, lameness at walk, lameness at trot, and pain at palpation/manipulation of the affected joint. The scores for each of these parameters were combined to give a clinical sum score (CSS). The owner evaluation used the Canine Brief Pain Inventory, a two-part instrument consisting of the pain severity score (PSS) and the pain interference score (PIS).
For the veterinarian assessment, dogs were classed as responders if the CSS score decreased in any of the follow-up visits, with the primary efficacy endpoint being the percentage of CSS responders at the end of the study. For the owner assessment, a dog was classified as a responder if it had a decrease ≥1 in PSS, and ≥2 in PIS in any visit compared to baseline. The secondary efficacy endpoint was the percentage of CBPI responders at the end of the study. Safety was evaluated by recording adverse events (AEs) throughout the study.
A total of 242 dogs were enrolled in the study. On day 42, enflicoxib at 4 mg/kg showed the highest percentage of responders as assessed by veterinarians (68%) and owners (84%), followed by mavacoxib (62% and 83%) and enflicoxib at 2 mg/kg (57% and 80%). All treatments reached statistical significance versus placebo at day 42. Analysis of a subset of dogs with severe OA (initial CCS ≥8) showed dogs in the enflicoxib at 4mg/kg and mavacoxib groups had a significantly higher percentage of responders compared to placebo from day 14 onwards. There were no significant differences in the frequency of adverse reactions among the different groups.
Limitations of the study include the short duration of the study, and the subjective nature of both veterinarian and owner assessments.
This study provides some evidence on the safety and efficacy of enflicoxib, a new NSAID, for the treatment of naturally occurring osteoarthritis. Further studies of longer duration are encouraged.
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