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Evaluation of Pexion® (Imepitoin) for Treatment of Storm Anxiety in Dogs: a Randomised, Double-Blind, Placebo-Controlled Trial

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Evaluation of Pexion® (Imepitoin) for Treatment of Storm Anxiety in Dogs: a Randomised, Double-Blind, Placebo-Controlled Trial Received: 20 July 2020 Revised: 7 October 2020 Accepted: 3 December 2020 DOI: 10.1002/vetr.18 ORIGINAL RESEARCH Evaluation of Pexion® (imepitoin) for treatment of storm anxiety in dogs: A randomised, double-blind, placebo-controlled trial Irina Perdew1 Carrie Emke1 Brianna Johnson1 Vaidehi Dixit2 Yukun Song2 Emily H. Griffith2 Philip Watson3 Margaret E. Gruen1 1 Department of Clinical Sciences, North Abstract Carolina State University College of Background: While often grouped with other noise aversions, fearful Veterinary Medicine, Raleigh, North Carolina, USA behaviour during storms is considered more complex than noise aversion 2 Department of Statistics, North Carolina alone. The objective here was to assess the effect of imepitoin for the treat- State University College of Sciences, Raleigh, ment of storm anxiety in dogs. North Carolina, USA Methods: In this double-blind, placebo-controlled randomised study, eligible 3 Ingelheim am Rhein, Boehringer-Ingelheim dogs completed a baseline then were randomised to receive either imepitoin Vetmedica GmbH, Ludwigshafen am Rhein, (n = 30; 30 mg/kg BID) or placebo (n = 15) for 28 days. During storms, owners Germany rated their dog’s intensity for 16 behaviours using a Likert scale. Weekly, own- Correspondence ers rated intensity and frequency of these behaviours. Summary scores were Margaret E. Gruen, Department of Clinical compared to baseline and between groups. Sciences, North Carolina State University Results and Conclusions: Imepitoin was significantly superior to placebo in College of Veterinary Medicine, 1060 William Moore Drive, Raleigh NC 27607, USA. storm logs and weekly surveys for weeks 2 and 4, and in the end-of-study sur- Email: [email protected] vey. Mild/moderate adverse events were reported in 26 patients (24 active: two placebo); the most frequent adverse event was ataxia. Owners of dogs in the imepitoin group, compared to placebo, were significantly more likely to report that treatment reduced their dogs fear and anxiety during storms (p < 0.001) and other noise events (p < 0.001). Twice daily administration of imepitoin decreased anxiety scores in dogs with storm anxiety. Future work may evaluate optimal dosage regimens. INTRODUCTION storm’s occurrence. Here, we refer to this condition as ‘storm anxiety’ to address recent shifts in terminology Noise aversion is a common behavioural disorder in and include dogs who do not meet the criteria for a dogs, with affected dogs showing signs of fear and phobic response,1,4,5 but show signs of fear and anx- anxiety in response to noise stimuli. Common signs iety during storms. Meteorological changes including associated with noise aversion include hypersali- shifts in barometric pressure, wind, static electricity vation, panting, hiding, vocalising and attempts to and illumination levels have all been suggested as escape; these signs may be severe enough to result additional triggers for dogs with storm anxiety.6 The in self-harm.1 Theprevalenceofdogswithfearful contribution of each of these factors is difficult to responses to noise has been reported as up to 25– delineate; however, their possible influence means 50%, making it among the most common canine that storm anxiety must be considered separately behavioural disorders.2 When severe, this condition from other noise aversions and is nearly impossible is termed ‘phobia’, denoting a profound, non-graded to model using noise alone. Storm anxiety may be the and extreme response.1,3 Fear of thunder has been only noise-associated condition a dog is affected with, considered a subset of noise aversion; in this defini- or they may have aversions to other noise stimuli. A tion, the sound of the thunder is the fear-inducing recent survey study found a high correlation between stimulus. This has often been referred to as storm fear of thunder and certain other noises; specifically, phobia or thunderstorm phobia. However, storms a majority of dogs with fear of thunder showed fear of encompass more than just the noise of thunder, and fireworks (92.9%) and gunshots (73.8%) with a lower dogs who show signs of fear and anxiety associated percentage showing fear to other noises like vacuums, with storms often show signs well in advance of a sirens, etc. (53.5%). Dogs with fear of fireworks did This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. © 2021 The Authors. Veterinary Record published by John Wiley & Sons Ltd on behalf of British Veterinary Association Vet Rec. 2021;e18. wileyonlinelibrary.com/journal/vetr 1of9 https://doi.org/10.1002/vetr.18 2of9 Veterinary Record not always show fear of thunder (71.8%) suggesting in dogs; these included dogs with fears of noises in that these two stimuli have individual characteristics addition to other behavioural concerns. They found triggering signs of fear in dogs.7 that imepitoin given twice daily, in conjunction with Treatment for dogs with noise aversion involves a a behavioural modification programme was effective combination of environmental and behavioural mod- in the reduction of fear and anxiety scores. This case ification and pharmacologic therapy. Two drugs have series provided evidence to support further investiga- recently been approved for the treatment of noise tion of imepitoin for the treatment of fear and anxi- aversion in dogs,8,9 yet none is labelled for the treat- ety disorders in dogs, including storm anxiety. Given ment of storm anxiety specifically. Indeed, only one its anxiolytic properties and the ability to use imepi- medication combination, clomipramine and alprazo- toin long term, our objective in this study was to assess lam, has been evaluated specifically for the treatment the efficacy of imepitoin specifically for treatment of of storm anxiety (referred to as storm phobia) in client- storm anxiety in dogs. We hypothesised that imepi- owned dogs.6 Existing treatments for storm anxiety toin would decrease the clinical signs of anxiety in often include selective serotonin reuptake inhibitors, dogs with a history of storm anxiety as compared to such as fluoxetine, with an additional episodic treat- placebo. ment administered prior to or during a storm.1,10 This presents a feasibility concern for many owners of dogs with storm anxiety, particularly if a storm is unex- MATERIALS AND METHODS pected. In some parts of the globe, such as the south- ern region of the United States, storms occur with All dogs enrolled in the study were client-owned and some regularity during the ‘storm season’ that extends remained with their owners for the duration of the from early spring through late fall. An effective treat- study. Owners provided written informed consent; all ment that could be used daily during this period, and procedures were carried out with approval from the episodically outside of it (or in other regions), would North Carolina State University Institutional Animal fill a gap in our currently available drugs. Care and Use Committee (Protocol #18-053-O). Imepitoin is a partial gamma aminobutyric acid Subjects were recruited via flyers and advertise- (GABA)-A agonist in the benzodiazepine class that ments on social media and through emails to area has been approved as a treatment for noise aversion veterinarians. Interested owners completed an online in dogs in the United States and European Union. pre-screening questionnaire for preliminary assess- In a randomised, placebo-controlled trial, imepitoin ment of eligibility. To be eligible, dogs had to be was found to be effective in decreasing signs of noise between 1 and 12 years of age, and weigh between aversion (to fireworks) in dogs.8 It is approved at a 2 and 50 kg (4.4–110 lb). Dogs were further required dosage of 30 mg/kg twice daily to be given 2 days to have been living with their owner for at least 1 prior to a noise event and continuing through the end year, have a stable history of storm anxiety (for at of the event. In laboratory-based studies, imepitoin least 1 year) and have a qualifying score (≥ 30) for also showed efficacy in a noise-induced model of fear intensity on the Lincoln Sound Sensitivity Scale.19 To and anxiety in dogs, using thunder track as the noise complete the Lincoln Sound Sensitivity scale, owners stimulus,11 but has not been previously evaluated for rate their dog’s frequency and intensity of signs for 16 clinical cases. As a class of psychoactive drugs, ben- behaviours along a scale from 0 to 3 (frequency) and zodiazepines have also long been used alone or as 1 to 5 (intensity) where lower scores indicate less fre- adjunctive medications for the treatment of anxiety quent or severe behaviour. Dogs were excluded if they conditions, including storm anxiety, in dogs.6,12,13 In had a history of aggressive behaviour, significant sys- a retrospective study on the use of diazepam for anx- temic disease (cardiovascular, hepatic, renal, etc.), or iety conditions in dogs, all owners who administered were taking other psychoactive medications; owners diazepam for storm anxiety reported the treatment were excluded if they had a major life event (move, to be at least somewhat effective for their dogs14;in new baby, etc.) planned during the period of the a prospective study, alprazolam (in conjunction with study. If owners had been using adjunctive treatments clomipramine) was associated with a 52% decrease (pheromones, pressure wraps, etc.) or behavioural in signs of storm anxiety.6 A limitation of the use modification, these were allowed to continue as long of benzodiazepines is the risk of adverse effects – as they had been in use for at least 4 weeks and dogs such as ataxia, behavioural disinhibition and idiosyn- still met entry criteria for their Lincoln Sound Sensitiv- cratic excitatory reactions – and the development of ity Score (LSSS) scores; no new adjunctive treatments tolerance.14 As a low affinity partial agonist, imepitoin or behavioural modifications were allowed during the may decrease the potential for the development of tol- study period.
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