Objective: Toassesstheefficacy,safetyandtolerabilityofsodiumvalproate(800mg/die) compared withplaceboinmedication-overuseheadachepatientswithahistoryofmigraine without aura. Methods: This isamulticenter,randomized,double-blind,placebo-controlledstudyenrolled medication-overuse headachepatientsfora3-monthtreatmentperiodwithsodiumvalproate (800 mg/day)orplaceboaftera6dayoutpatientdetoxification regimen,followedbya3-month follow-up. Primaryoutcomewasdefined bytheproportionofpatientsachieving Z50% reduction inthenumberofdayswithheadachepermonth(responders)fromthebaselineto the last4weeksofthe3-monthtreatment.Multivariatelogisticregressionmodelswereusedon the primaryendpoint,adjustingforage,sex,diseaseduration,comorbidityandsurgery.The last-observation-carried-forward methodwasusedtoadjustformissingvalues. Results: Nine sitesenrolled130patientsand,aftera6-daydetoxification phase,randomized 88 eligiblepatients.The3-monthresponderratewashigherinthesodiumvalproate(45.0%) than intheplaceboarm(23.8%)withanabsolutedifferenceofabout20%(p=0.0431). Sodium valproate hadsafetyandtolerabilityprofiles comparabletoplacebo. Conclusions: The presentstudysupportstheefficacy andsafetyofsodiumvalproateinthe treatment ofmedicationoveruseheadachewithhistoryofmigraineafterdetoxification.
Sodium valproate in migraine without aura and medication overuse headache: A randomized controlled trial.
SARCHIELLI, Paola;CAPRONI, STEFANO;CORBELLI, ILENIA;CALABRESI, PAOLO;
2014
Abstract
Objective: Toassesstheefficacy,safetyandtolerabilityofsodiumvalproate(800mg/die) compared withplaceboinmedication-overuseheadachepatientswithahistoryofmigraine without aura. Methods: This isamulticenter,randomized,double-blind,placebo-controlledstudyenrolled medication-overuse headachepatientsfora3-monthtreatmentperiodwithsodiumvalproate (800 mg/day)orplaceboaftera6dayoutpatientdetoxification regimen,followedbya3-month follow-up. Primaryoutcomewasdefined bytheproportionofpatientsachieving Z50% reduction inthenumberofdayswithheadachepermonth(responders)fromthebaselineto the last4weeksofthe3-monthtreatment.Multivariatelogisticregressionmodelswereusedon the primaryendpoint,adjustingforage,sex,diseaseduration,comorbidityandsurgery.The last-observation-carried-forward methodwasusedtoadjustformissingvalues. Results: Nine sitesenrolled130patientsand,aftera6-daydetoxification phase,randomized 88 eligiblepatients.The3-monthresponderratewashigherinthesodiumvalproate(45.0%) than intheplaceboarm(23.8%)withanabsolutedifferenceofabout20%(p=0.0431). Sodium valproate hadsafetyandtolerabilityprofiles comparabletoplacebo. Conclusions: The presentstudysupportstheefficacy andsafetyofsodiumvalproateinthe treatment ofmedicationoveruseheadachewithhistoryofmigraineafterdetoxification.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
