hepurposeofthisreportwastoupdatethe2006InternationalLeagueAgainstEpilepsy(ILAE)reportandidentifythelevelofevidenceforlong-termefficacyoreffectivenessforantiepilepticdrugs(AEDs)asinitialmonotherapyforpatientswithnewlydiagnosedoruntreatedepilepsy.AllapplicablearticlesfromJuly2005untilMarch2012wereidentified,evaluated,andcombinedwiththepreviousysis(Glauseretal.,2006)toprovideacomprehensiveupdate.
Thepriorysismethodologywasutilizedwiththreemodifications:(1)thedetectablenoninferiorityboundaryapproachwasdroppedandbothfailedsuperioritystudiesandprespecifiednoninferioritystudieswereyzedusinganoninferiorityapproach,(2)thedefinitionofanadequatecomparatorwasclarifiedandnowincludesanabsoluteminimumpointestimateforefficacy/effectiveness,and(3)therelationshiptablebetweenclinicaltrialratings,levelofevidence,andconclusionsnolongerincludesarecommendationcolumntoreinforcethatthisreviewofefficacy/evidenceforspecificseizuretypesdoesnotimplytreatmentrecommendations.
Thisevidencereviewcontainsoneclarification:ThecommissionhasdeterminedthatclassIsuperioritystudiescanbedesignedtodetectuptoa20?solute(ratherthanrelative)differenceinthepointestimateofefficacy/effectivenessbetweenstudytreatmentandcomparatorusinganintent-to-treatysis.SinceJuly,2005,threeclassIrandomizedcontrolledtrials(RCT)and11classIIIRCTshebeenpublished.Thecombinedysis(1940-2012)nowincludesatotalof64RCTs(7withclassIevidence,2withclassIIevidence)and11meta-yses.
Newefficacy/effectivenessfindingsincludethefollowing:levetiracetamandzonisamidehelevelAevidenceinswithpartialonsetseizuresandbothethosuximideandvalproicacidhelevelAevidenceinchildrenwithchildhoodabsenceepilepsy.
Therearenomajorchangesinthelevelofevidenceforanyothersubgroup.LevetiracetamandzonisamidejoincarbamazepineandphenytoinwithlevelAefficacy/effectivenessevidenceasinitialmonotherapyforswithpartialonsetseizures.AlthoughethosuximideandvalproicacidnowhelevelAefficacy/effectivenessevidenceasinitialmonotherapyforchildrenwithabsenceseizures,therecontinuestobeanalarminglackofwelldesigned,properlyconductedepilepsyRCTsforpatientswithgeneralizedseizures/epilepsiesandinchildreningeneral.
Thesefindingsreinforcetheneedformulticenter,multinationaleffortstodesign,conduct,andyzefutureclinicallyrelevantadequatelydesignedRCTs.Whenselectingapatient'sAED,allrelevantvariablesandnotjustefficacyandeffectivenessshouldbeconsidered.
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