Onset of efficacy and tolerability following the initiation dosing of long-acting paliperidone palmitate post-hoc analyses of a randomized, double-blind clinical trial 英文参考文献.docVIP

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Onset of efficacy and tolerability following the initiation dosing of long-acting paliperidone palmitate post-hoc analyses of a randomized, double-blind clinical trial 英文参考文献.doc

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Onset of efficacy and tolerability following the initiation dosing of long-acting paliperidone palmitate post-hoc analyses of a randomized, double-blind clinical trial 英文参考文献

Bossieetal.BMCPsychiatry2011,11:79 /1471-244X/11/79 RESEARCH ARTICLE OpenAccess Onsetofefficacyandtolerabilityfollowingthe initiationdosingoflong-actingpaliperidone palmitate:post-hocanalysesofarandomized, double-blindclinicaltrial CynthiaABossie1*?,JenniferKSliwa1?,Yi-WenMa2?,Dong-JingFu1?andLarryAlphs1? Abstract Background:Paliperidonepalmitateisalong-actinginjectableatypicalantipsychoticfortheacuteand maintenancetreatmentofadultswithschizophrenia.Therecommendedinitiationdosingregimenis234mgon Day1and156mgonDay8viaintramuscular(deltoid)injection;followedby39to234mgonce-monthly thereafter(deltoidorgluteal).Thesepost-hocanalysesaddressedtwocommonlyencounteredclinicalissues regardingtheinitiationdosing:thetimetoonsetofefficacyandtheassociatedtolerability. Methods:Ina13-weekdouble-blindtrial,652subjectswithschizophreniawererandomizedtopaliperidone palmitate39,156,or234mg(correspondingto25,100,or150mgequivalentsofpaliperidone,respectively)or placebo(NCT.Subjectsrandomizedtopaliperidonepalmitatereceived234mgonDay1,followedby theirrandomizedfixeddoseonDay8,andmonthlythereafter,withnooralantipsychoticsupplementation.The onsetofefficacywasdefinedasthefirsttimepointwherethepaliperidonepalmitategroupshowedsignificant improvementinthePositiveandNegativeSyndromeScale(PANSS)scorecomparedtoplacebo(Analysisof Covariance[ANCOVA]modelsandLastObservationCarriedForward[LOCF]methodologywithoutadjustingfor multiplicity)usingdatafromtheDays4,8,22,and36assessments.Adverseevent(AE)ratesandrelativerisks(RR) with95%confidenceintervals(CI)versusplaceboweredetermined. Results:Paliperidonepalmitate234mgonDay1wasassociatedwithgreaterimprovementthanplaceboonLeast Squares(LS)meanPANSStotalscoreatDay8(p=0.037).AftertheDay8injectionof156mg,therewas continuedPANSSimprovementatDay22(p≤0.007vs.placebo)andDay36(p0.001).Takentogetherwith resultsinthe39mgand234mgDay8arms,thesefindingssuggestatrendtowardsadose-dependentresponse. DuringDays1to7,AEsreportedin≥2%ofpaliperidonepalmitatesubjects(2