PT - JOURNAL ARTICLE AU - A Shukralla AU - C Tudur-Smith AU - A G Marson TI - 054 Can randomised controlled trial data from non-epilepsy indications be included in meta-analysis for AEDs used in epilepsy? An analysis of adverse event data AID - 10.1136/jnnp-2011-301993.96 DP - 2012 Mar 01 TA - Journal of Neurology, Neurosurgery & Psychiatry PG - e1--e1 VI - 83 IP - 3 4099 - http://jnnp.bmj.com/content/83/3/e1.220.short 4100 - http://jnnp.bmj.com/content/83/3/e1.220.full SO - J Neurol Neurosurg Psychiatry2012 Mar 01; 83 AB - Aim To determine if adverse event (AE) outcomes from RCTs of AEDs across non-epilepsy indications (neuropathy & migraine) can be meta-analysed with data from epilepsy trialsMethod We searched for RCTs meeting inclusion criteria. AEDs included were topiramate, gabapentin, valproate, oxcarbazepine, lacosamide and others. Extracted data were analysed using RevMan 5.0. AEs analysed were; dizziness, ataxia, headache, fatigue, nausea, somnolence, AE withdrawals and any AE. Effect size summary statistics were calculated using the Mantel-Haenszel method. Statistical heterogeneity was assessed using a random effects model generating an I2 statistic.Results Hundred and six RCTs met inclusion criteria. When dizziness was analysed, test between indications showed no heterogeneity (I2=0%) for gabapentin, topiramate, lacosamide and lamotrigine. However, heterogeneity was significant (I2=59%) for oxcarbazepine. When fatigue was the AE outcome, there was no heterogeneity (I2=0%) when we analysed data for gabapentin, lamotrigine, lacosamide, oxcarbazepine and topiramate. When somnolence was the AE outcome, heterogeneity was insignificant for oxcarbazepine (I2=8%), lacosamide (I2=0%) and topiramate (I2=0%), but significant for gabapentin (I2=56%) and lamotrigine (I2=60%). In instances where there was significant heterogeneity, the size of relative risk was greater in the non-epilepsy indicationsConclusion AEs of AEDs from non-epilepsy trials could be used in meta-analysis due to low statistical heterogeneity for some interventions and outcomes. Nevertheless this was not the case in all AEDs or outcomes. Effect sizes were larger in the non-epilepsy indications overall.