BIBLIOGRAPHIC REFERENCE TABLE FOR SODIUM VALPROATE IN CHILDHOOD EPILEPSY

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1 BIBLIOGRAPHIC REFERENCE TABLE FOR SODIUM VALPROATE IN CHILDHOOD EPILEPSY Bibliographic Marson AG et al. for (Review). The Cochrane 2000 De Silva M et al. Romised or for childhood. Lancet, 1996; 347: review romized controlled studies; studies may be double, single or unblinded Romised, prospective long-term clinical 1256 Children adults 167 Children aged 3-16 years Intervention Comparison Length efficacy tolerability when used as in people with partial onset (simple partial, complex partial or secondarily generalizing tonic-clonic ) or generalized efficacy toxicity carbamazpeine as in children with with efficacy toxicity carbamazpeine as 12 Time to withdrawal allocated (due to lack efficacy or intolerable adverse effects); time to (range 3-88) Time to first ; time to achieve a 1-year remission from all Data analysed using a stratified logrank analysis with results expressed as hazard ratios (HR) 95% confidence intervals (CIs) where a HR >1 indicates an event is more likely on. The main overall results (HR) : time to withdrawal 0.97 (95% CI ); 12 remission 0.87 (95% CI ); first 1.09 (95% CI ) Significant difference groups in the proportion children withdrawn from the romized drugs because unacceptable sideeffects (X 2 = 35.1, P=0.001). s in phenobarbitone group more likely to have the drug withdrawn than those in the other groups (X 2 = 33.9, p<0.001; odds ratio % CI ). No significant difference in the proportion Source External sources support - Wellcome Trust UK; Medical Resarch Council UK Ciba- Geigy, Parke- Davis Sani Results suggest no overall difference for the outcome described. The test for an interaction between type was nonsignificant for time to withdrawal 12- remission, but significant for. Overall outcome with all 4 drugs was good. Phenobarbitone showed an unacceptable incidence side-effects that necessitated withdrawal this. all

2 Verity CM et al. A in paediatric. Dev Med Child Neurol 195; 37(2): Thilothammanl N et al. Comparison Romised Romised double blind 260 Children aged 5-16 years 151 Children aged 4-12 years Intervention Comparison Length To assess the long-term efficacy side-effect priles in children with primary generalized (with or without secondary generalization) Double-blind romised, placebo Comparison phenytoin 3 years Efficacy (remission analyses at 6, ) tolerability s (mean 29 Seizure recurrence withdrawn other 3 groups. Overall analysis for the 167 children showed that by 3 years followup, 20% (95% CI 13-26) had remained free 73% had achieved a 1 year remission. Remission analyses produced no statistically significant difference between s at 6 (RR 0.98; p=0.91; 95% CI 73 to 1.32); a marginal but nonsignificant advantage for in 12 remission (RR 1.05; p=0.75; 95% CI 0.76 to 1.46) a larger but still statistically insignificant advantage for in 24 remission (RR 1.44; p=0.10; 95% CI ) Both drugs achieved a high degree control with 75% having at least % at least 2 years freedom from. 127 children followed up completely. During the study period, Source Sani Winthrop Internation al Clinical Epidemiol Little difference in overall efficacy drugs. Analysis failures showed there was little difference in failure rates drugs All 3 drugs equally effective in controlling

3 phenytoin with : romised study. Indian Pediatr 1996; 33(7): Callaghan N et al. A prospective study between, phenytoin as in previously untreated recently with. J Neurol Neurosurg Psychiatry 1985; 48: Prospective, romised study 180 Adults children Intervention Comparison Length controlled study in with toniclonic Romised, phenytoin in previously untreated recently with ) assessment sideeffects, phenytoin Upto 48 (median ) Response to 16 (95%CI 19-45) in phenobarbitone group, 14 (95% CI 16-41) 10 (95% CI 10-34) in the group developed at least one attack convulsion. Of these, 32/40 because their serum AED levels low or they irregular in taking the drug. More than one side-effects was observed in 32% children on 40% on phenytoin 19% on this difference was statistically significant (p<0.05) Generalised tonic clinic (without focal features) all 3 drugs improved control. Poor response was similar for all 3 drugs. Ratio for excellent to good control varied this difference is statistically significant when phenytoin is compared with for excellent control (p<0.01) Partial with or without secondary attacks all 3 drugs less effective for partial. No Source ogy Network; Boots Pharmace uticals; Reckitt Colman; Rhone- Poulenc Labaz Geigy, Warner- Lambert. Sideeffects minimal with followed by phenobarbitone. Though sideeffects more frequent with most them disappeared on adjusting drug dosage. All 3 drugs highly effective in the control but less effective for partial. Excellent or good control was achieved with therapeutic levels but with subtherapeutic levels phenytoin

4 Tudur Smith C et al. Phenytoin for partial onset (Review) The Cochrane 2001 Steinhf BJ et al. The LAM- SAFE Study: Lamotrigine or in focal epilepsies in adults. Seizure 2005; 14(8): Coppola G et al. Lamotrigine valproic acid as first-line review romised, controlled s in adults children with partial epeilspy Open label romised Romised, open-label parallel group design 669 Children adults 239 Adults 12 years over 38 Children aged 3 to 13 years Intervention Comparison Length To review the best evidence comparing phenytoin when used as in people with partial onset or with or without other types s with focal idiopathic epilepsies s with typical absence Comparison phenytoin with Those with epilepsies (n=63) romised to receive either lamotrigine or Lamotrigine with 12 Time to withdrawal ; time to 12 time to 6 post romisati on 24 weeks Primary outcome measure was the number -free during study weeks Up to 12 Primary outcome measure significant difference m Data analysed using stratified logrank analysis with results expressed as HR 95% CI; HR>1 indicates an event is more likely on phenytoin. Results only apply to tonic-clonic. Time to withdrawal allocated 1.10 (95% CI 0.79 to 1.54); time to 12 remission 1.04 (95% CI 0.78 to 1.38); time to 6 remission 0.89 (95% CI 0.71 to 1.11); 0.92 (95% CI 0.74 to 1.14) In the group, 83.3% the (25/30) became free compared to 60.6% lamotrigine (20/33). During study weeks (not statistically significant) After 1, 10 (52.6%) taking VA 1 (5.3%) taking Source External sources support Medical Research Council UK; NHS R+D UK Glaxo Smith Kline None No overall difference two drugs No particular difference 3 tested antiepileptic drugs suggest that the 3 agents are equal in their effectiveness Both valproic acid lamotrigine can be efficacious in

5 in typical absence : an open-label, romised, parallel group study. Epilepsia, 2004; 45(9): Intervention Comparison Length romised to receive lamotrigine or freedom LTG free (p=0.004). At 3, freedom was seen in 12 (63.1%) taking VA in 7 (36.8%) on LTG (difference failing to reach statistical significance p=0.19). At % VA 52.6% LTG free (p=0.51) Source absence although shows a much faster onset action Posner EB et al. Ethosuximide, or lamotrigine for absence in children (Review) The Cochrane 2005 Wheless JW et al. Topiramate, : comparison on. J Child Neurol 2004; 19(2): review romised parallel group or add-on s in children Romised, 613 ( whom 119 children or adolescent s) Adults children (6-16 years) efficacy topiramate with as first line therapy in with Topiramate with Variable since was continued until the exited or until 6 after the last patient was enrolled Efficacy tolerability/s afety For the paediatric subsection efficacy analyses showed no statistically significant differences between topiramate or. Fewer in the topiramate groups discontinued due to adverse effects compared to No sources support supplied Johnson Johnson Pharmace utical Research Developm ent 5 small s found which 4 poor methodological quality. Insufficient number. No results For the paediatric subsection efficacy analyses showed no statistically significant differences between topiramate or.