Efficacy of olanzapine long-acting injection in patients with acutely exacerbated schizophrenia an insight from effect size comparison with historical oral data.docVIP

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Efficacy of olanzapine long-acting injection in patients with acutely exacerbated schizophrenia an insight from effect size comparison with historical oral data.doc

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Efficacy of olanzapine long-acting injection in patients with acutely exacerbated schizophrenia an insight from effect size comparison with historical oral data

Detkeetal.BMCPsychiatry2012,12:51 /1471-244X/12/51 RESEARCH ARTICLE OpenAccess Efficacyofolanzapinelong-actinginjectionin patientswithacutelyexacerbatedschizophrenia: aninsightfromeffectsizecomparisonwith historicaloraldata HollandCDetke1*,FangyiZhao1andMichaelMWitte2 Abstract Background:Totreatacuteschizophrenia,along-actinginjectableantipsychoticneedsarapidonsetofactionand therapeuticprofilesimilartothatoforalagents.Thepresentpost-hocanalysescomparedresultsfroma randomized,double-blind,placebo-controlledtrialofolanzapinelong-actinginjection(LAI)foracuteschizophrenia withthoseobservedinsimilarlydesignedtrialsoforalolanzapine. Methods:Six-weekresultsfromtheolanzapineLAIstudy(N=404)werecomparedwiththoseof3oralstudies (study1:olanzapinevs.haloperidolvs.placebo[N=335];study2:olanzapinevs.haloperidolvs.low-dose olanzapine[N=431];study3:olanzapinevs.placebovs.low-doseolanzapine[N=152]).Allpatientshadbaseline BriefPsychiatricRatingScale(BPRS)scores≥24(0–6scale).Six-weekeffectsizeswerecalculated.Efficacyonset, pharmacokinetics,discontinuations,weightgain,andextrapyramidalsymptomswerealsoassessed. Results:At6weeks,meanBPRSscoresdecreasedby14to15pointsforolanzapineLAI(405mg/4weeks,210or 300mg/2weeks),by8to16fororalolanzapine(10±2.5or15±2.5mg/day),andby12to13forhaloperidol (15±5mg/day).Forthosesamedosegroups,effectsizesvs.placebofortheBPRSwere0.7to0.8forolanzapine LAI,0.5to0.7fororalolanzapine,and0.6forhaloperidol.Thefirststatisticallysignificantseparationfromplaceboon theBPRSoccurredat3daysfortheolanzapineLAIgroupsandat1weekfororalolanzapineandhaloperidol (15±5mg/day)inoralstudy1althoughaslateasweek6forthe10-mg/dayolanzapinedoseinoralstudy3. Olanzapineconcentrationsweresimilaracrossstudies.Weightgain≥7%ofbaselineoccurredinupto35%of olanzapineLAIandoralpatientsversusupto12%ofhaloperidolandplacebopatients.Extrapyramidalsymptoms werelowestintheolanzapineLAIgroupsandsignificantlygreaterinthehaloperidolgroups.Nopost-injection delirium/sedationsyndromeeventsoccurredintheolanzap