There are a number of anti-epileptic drugs available for the treatment of partial onset seizures in patients with epilepsy. This study is a systematic review of the published literature on anti-epileptic drugs and is designed to compare the relative effectiveness and tolerability of a selection of them with retigabine. The drugs chosen for this comparison were lacosamide, pregabalin, tiagabine, zonisamide and eslicarbazepine. They were chosen because they belong to the newer generation of drugs for epilepsy (as does retigabine) and they have a similar license as well as having published data from studies that were conducted in similar patient populations with similar methods. GSK commissioned YHEC (York Health Economic Consortium) to carry out this review and analysis. YHEC identified relevant studies from international databases. These studies had compared one of the chosen anti-epileptic drugs with placebo. The results were pooled and combined in order to summarize the data for individual drugs as well to compare the results for different drugs with each other and with retigabine. Since none of the individual clinical studies compared one active drug with another, this systematic review is an indirect comparison of these drugs, using an established and recognised methodology which has well understood limitations.
Study Type
OBSERVATIONAL
Enrollment
6,498
oral - all doses
oral - all doses
oral - all doses
oral - all doses
oral - all doses
Responder Rate
Proportion of patients who respond to treatment (50% reduction in seizure frequency from baseline)
Time frame: Duration of studies included in the systematic review up to 28 weeks of double blind period
Median Seizure reduction
Median percent reduction in seizure frequency from baseline
Time frame: Duration of studies included in the systematic review up to 28 weeks of double blind period
Seizure severity
Seizure severity (any definitions acceptable)
Time frame: Duration of studies included in the systematic review up to 28 weeks of double blind period
Time to onset of treatment effect
Time to onset of treatment effect
Time frame: Duration of studies included in the systematic review up to 28 weeks of double blind period
Seizure free patients
Proportion of patients who are seizure free (and time period over which this was measured)
Time frame: Duration of studies included in the systematic review up to 28 weeks of double blind period
Changes in HRQoL
Changes in HRQoL
Time frame: Duration of studies included in the systematic review up to 28 weeks of double blind period
All drop outs
Proportion of patients who drop out of the studies for any reason
Time frame: Duration of studies included in the systematic review up to 28 weeks of double blind period
Drop outs due to AE
Proportion of patients who drop out of the studies (as a result of adverse events i.e. tolerability)
Time frame: Duration of studies included in the systematic review up to 28 weeks of double blind period
Adverse events
Percentage of patients reporting 5 key adverse events identified by the Cochrane Epilepsy Group as common and important adverse effects of antiepileptic drugs: ataxia, dizziness, fatigue, nausea or somnolence
Time frame: Duration of studies included in the systematic review up to 28 weeks of double blind period
Mortality
Mortality
Time frame: Duration of studies included in the systematic review up to 28 weeks of double blind period
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