Effectiveness of imepitoin for the control of anxiety and fear associated with noise phobia in dogs


Abstract

Background: Noise phobia is a common behavior problem in dogs for which there are limited treatment options.

Objective: To evaluate the efficacy and safety of imepitoin in comparison to placebo for the control of anxiety and fear associated with noise phobia in dogs.

Animals: Two hundred thirty-eight client-owned dogs with noise phobia were recruited in veterinary clinics.

Methods: This placebo-controlled, randomized, double-blinded, clinical trial used a predictable noise event as eliciting context, the traditional New Year''s Eve fireworks in Germany and the Netherlands. Owners began treatment 2 days before the anticipated noise event with administration of either imepitoin 30 mg/kg body weight Q12h or placebo for 3 consecutive days. On New Year''s Eve, owners noted their observations of their dog''s fear and anxiety behavior at 1600, 2200, 0020, and 0100 hours and scored the overall treatment effect on the following day.

Results: In the 16-item owner report of fear and anxiety signs, fear and anxiety behaviors were significantly reduced under imepitoin treatment compared to placebo (delta -6.1 scoring points; P < .0001). A significantly higher proportion of owners reported a good or excellent overall treatment effect in the imepitoin group compared to placebo (odds ratio 4.689; 95% CI, 2.79-7.89; P < .0001).

Conclusion: Imepitoin effectively controls fear and anxiety associated with noise phobia in dogs.

Keywords: anxiolytic; clinical trial; firework; imepitoin; noise aversion; noise phobia; noise sensitivity.

Conflict of interest statement

This publication followed the GPP3 guidelines. O. Engle, R. Klee, B. Francke, and H‐W. Muller are employees of Boehringer Ingelheim Vetmedica GmbH, Germany, the marketing authorization holder of Pexion, containing imepitoin as active principle. O. Engle is holder of a patent related to imepitoin. D. Mills acted as consultant for Boehringer Ingelheim.

Figures

Figure 1
Figure 1
Study design and schedule of events
Figure 2
Figure 2
Flowchart of exclusions from the analyzed populations. From all dogs randomized into the study, dogs that received at least 1 dose of study medication were included in the safety analysis. Cases were excluded from primary efficacy population (Full Analysis Set, FAS) if there were not sufficient data to evaluate the end points (eg, termination of study before New Year''s Eve). Excluding cases with protocol deviations formed additional per protocol sets (PPS). As per FDA guidance, also clinical sites with less than 4 evaluable cases had to be excluded, setting up the per protocol population for FDA (US‐PPP)
Figure 3
Figure 3
Histogram of owner''s rating of overall treatment effect. There was a significantly higher proportion of owners reporting a good or excellent treatment effect in the imepitoin group compared to the placebo (P?<?.0001) with an odds ratio of 4.7 (95% confidence interval, 2.79‐7.89)
Figure 4
Figure 4
Evolution of anxiety score over time at baseline and on New Year''s Eve. Anxiety behaviors were significantly reduced under imepitoin treatment compared to placebo (P?<?.0001)
Figure 5
Figure 5
Ataxia was the most frequently reported adverse event in the imepitoin group. It was reported as occurring on the day of treatment initiation and resolving spontaneously under continuation of treatment in most cases on the same or the next day. Resolution decreased in an exponential fashion, with ~50% resolution within 24?hours after first drug administration. Data depicted as frequency of number of cases
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