JOURNAL SCAN
Imepitoin, a New Drug to Manage and Control
Canine Idiopathic Epilepsy
Efficacy, safety, and tolerability of imepitoin in dogs with newly diagnosed epilepsy in a randomised controlled clinical study with long
term follow up. Chris Rundfeldt, Andrea Tipold, Wolfgang Löscher. BioMed Central Veterinary Research (2015) 11:288
Summarised by Dr Liesel van der Merwe, BVSC MMedVet (Med)
required at least one of: 2-10 generalised seizures within 3 months, 1
cluster seizure event or status event
within 7 days. Dogs were excluded
if there was evidence of intracranial
disease, more than 10 seizures or any
other AEDs used within 3 months of
randomisation.
What they found:
Why they did it:
Canine epilepsy is seen in about 0.5 – 5% of the general canine population and is found in a wide range of
breeds. Idiopathic epilepsy represents about 60 – 70%
of all cases. Current therapy is unsatisfactory with only
15% of patients becoming seizure free and 30% of patients not experiencing significant seizure reduction
with phenobarbitone or potassium bromide, the most
commonly used anti-epileptic drugs (AEDs).
Imeptitoin, originally developed for epilepsy and anxiety in humans, was withdrawn from further development for humans due to inter-individual pharmacological variability. Initial studies showed the drug was
well tolerated in dogs and had good effects as a monotherapy and add-on therapy. The aim of this study
was to confirm the safety and efficacy of imepitoin in
dogs with idiopathic epilepsy.
How they did it:
A multi-centre randomized double blind clinical field
study was aimed at demonstrating the superiority
of imepitoin at 30 mg/kg bid (HD) over 1mg/kg bid
(LD), the lowest effective dose. In Phase 1, 120 dogs
were randomly placed into the HD and LD groups and
treated for 12 weeks. Dogs which completed Phase 1
or exited Phase 1 early due to poor response to medication were started on Phase 2, open label follow up
at 30 mg/kg bid for another 12 weeks
The sample size was calculated at a minimum of 54
patients per group, which was necessary to pick up
a difference of 1 seizure/28 days. Inclusion criteria
127 dogs were included in the study
with 66 dogs in the high dose (HD)
group and 61 in the low dose (LD)
group.
Dogs from 60 different
breeds were included. 29 (45%) of
dogs in the HD group and 30 (50%) dogs in the LD
group completed the study (24 weeks). 100 animals
continued to open label treatment in Phase 2. The
HD group, despite randomisation, had a significantly
higher starting baseline mean seizure frequency. Seizure frequency dropped in both groups, but was more
pronou