Table 4 Details of numbers of dogs, pre- and post- treatment seizure frequency, period of treatment, doses of AED(s), seizure frequency reduction/response after the initiation of treatment and efficacy statements for each study
References | Tipold et al.[14] | EMEA pseudo-placebo[13] | ||
|---|---|---|---|---|
AED evaluated | Imepitoin | |||
2 nd AED | - | - | - | PB (11 dogs) or Primidone (6 dogs) |
3 rd AED | - | - | - | - |
4 th AED | - | - | - | - |
No of dogs | After exclusion: 64 | First part: 127 | 12 | 17 |
Before exclusion: 93 | Second part (follow up): 100 (from the 127) | |||
Period of treatment (months) | 5 | 6 | mean, 7.7 ± 0.7 | mean, 5.6 ± 0.7 |
Dose of AED(s) (mg/kg) | 10-30 PO BID | High dose group: 30 PO BID | 5 PO BID for 1 week and then increased to 10–30 PO BID | Imepitoin: mean, 7.7 ± 0.7; |
Low dose: 1 PO BID [during the follow up all the 100 (53 from the previous high dose group and 47 from the low-dose) dogs were treated with the high dose only] | PB: 6–23 PO SID; Primidone: 25–53 PO SID | |||
Pre-treatment SF (seizures/month) | 2.3 (recorded over a period of 1.5 m) | High dose group: mean, 2.9 | median, 1.6 (recorded over a period of approx. 9 m) | median, 1.9 (recorded over a period of mean 1.6 years) |
Low dose group: mean, 2 | ||||
Post-treatment SF (seizures/month) | 1.1 | High dose group: mean, 2.2 | median, 0.72 | median, 2 |
Low dose group: mean, 1.8 | ||||
(For the follow up study: NA) | ||||
No of dogs that were failures | - | Unclear | 3/12 (25%) | 6/17 (35%) |
No of dogs with >0% - <50% reduction in SF | - | Unclear | 4/12 (33%) | 4/17 (24%) |
No of dogs with ≥50% - <100% reduction in SF | After exclusion: 18/64 (28%) | Unclear | 4/12 (33%) | 6/17 (35%) |
Before exclusion: 22/93 (24%) | ||||
No of dogs with 100% reduction in SF | After exclusion: 30/64 (47%) | First Part: High dose group: 44/127 (35%); Low dose: 6/127 (5%) | 1/12 (8%) | 1/17 (6%) |
Before exclusion:31/93 (33%) | Follow-up: High-high dose group: 19/53 (35%) and Low-high dose group: 24/47 (50%) | |||
No of dogs with >30% reduction in SF | - | As above | 9/12 (75%) | 11/17 (65%) |
95% CI successfully treated cases | After exclusion: 64% - 86% | Follow-up: 25-46% and 36-63% (but only for the seizure free dogs) | 13% - 69% | 18% - 64% |
Before exclusion: 47% - 67% | ||||
Overall evidence for/against recommending the use of an AED | Good evidence for recommending the use of imepitoin as a monotherapy AED. | |||
Insufficient evidence for recommending the use of imepitoin as an adjunct AED. | ||||