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Efficacy

The efficacy of SILEO® (dexmedetomidine oromucosal gel) have been proven in several placebo-controlled studies.

 

Efficacy

New Year’s Eve Study1

Efficacy was evaluated in two studies conducted on New Year’s Eve in Europe* to explore treatment effect under the actual conditions of use with an authentic noise stimulus: fireworks. These studies (randomised, multi-center, double-blind, placebo-controlled) evaluated the effect of SILEO in client-owned dogs with noise aversion. The first study found that 125 mcg/m2 was the lowest effective dose. The second study confirmed efficacy at 125 mcg/m2. Pet owners were allowed to administer up to 5 doses, with a minimum of 2 hours between doses, on an as needed basis.

SILEO had excellent or good treatment effect in 72% of dogs
Placebo had excellent or good treatment effect in 37% of dogs
The difference between the two groups was statistically significant at p<0.0001, in favour of SILEO

*Finland and Germany were selected because New Year’s Eve fireworks last throughout the night.

chart study 

Assessment of Signs and Extent of Fear and Anxiety

Pet owners were also asked to assess which signs of fear and anxiety their dogs exhibited, as well as the severity of those signs before and after each treatment.

Mean sum of behaviour scores over the treatment period was significantly different in favour of SILEO (p=0.0069)
Dogs treated with SILEO displayed less panting, trembling and trying to hide than those treated with control

Sums of behaviour scores

  

Summary

►  SILEO treatment effects were measurable, relevant and statistically significant (p<0.0001)
75% of SILEO-treated dogs scored an “excellent” or “good effect”
48% percent of placebo-treated dogs scored “no effect” or “worse"
Severity and frequency of signs was significantly lower in SILEO-treated dogs (p=0.0069) SILEO-treated dogs displayed less trembling, hiding and panting
Calming effect of SILEO was independent of sedation

  

Conclusion

The administration of 125 mcg/m2 of SILEO, as needed, up to five times with a minimum interval of two hours between doses is effective for the treatment of noise aversion in dogs.

 

 

References
1. Korpivaara et al. Dexmedetomidine oromucosal gel for alleviation of canine acute anxiety and fear associated with noise – a confirmatory clinical study.

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