Effects of paliperidone extended release on the symptoms and functioning of schizophrenia.docVIP

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Effects of paliperidone extended release on the symptoms and functioning of schizophrenia.doc

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Huangetal.BMCClinicalPharmacology2012,12:1 /1472-6904/12/1 RESEARCH ARTICLE OpenAccess Effectsofpaliperidoneextendedreleaseonthe symptomsandfunctioningofschizophrenia Min-WeiHuang1,2,Tsung-TsairYang3,Po-RenTen4,Po-WenSu5,Bo-JianWu6,Chin-HongChan7,Tsuo-HungLan7, I-ChaoLiu3,Wei-ChehChiu8,Chun-YingLi1,Kuo-ShengCheng1,9 andYu-ChiYeh8* Abstract Background:Weaimedtoexplorerelationsbetweensymptomaticremissionandfunctionalityevaluationin schizophreniapatientstreatedwithpaliperidoneextended-release(ER),asseeninanormalday-to-daypractice, usingflexibledosingregimensofpaliperidoneER.Weexploredsymptomaticremissionrateinpatientstreated withflexiblydosedpaliperidoneERby8itemsofPositiveandNegativeSyndromeScale(PANSS)andchangeof PersonalandSocialPerformance(PSP)scale. Method:Thiswasa12-weekmulticenter,open-label,prospectiveclinicalstudyconductedinin-patientandout- patientpopulations.Flexibledosingintherange3-12mg/daywasusedthroughoutthestudy.Allsubjects attendedclinicvisitsonweeks0,4,8,and12asusualclinicalpracticeforthe12-weekobservationperiod.Data weresummarizedwithrespecttodemographicandbaselinecharacteristics,efficacymeasurementwithPANSS scale,PSP,andsocialfunctioningscore,andsafetyobservations.Descriptivestatisticswereperformedtoidentify theretentionrateateachvisitaswellasthesymptomaticremissionrate.Summarystatisticsofaveragedosesthe subjectsreceivedwerebasedonallsubjectsparticipatinginthestudy. Results:Atotalof480patientswereenrolled.Amongthem,426patients(88.8%)hadevaluationatweek4and 350(72.9%)completedthe12-weekevaluation.Patientswithatleastmoderateseverityofschizophreniawere evaluatedas“mild”orbetteronPANSSscalebyall8itemsafter12weeksoftreatmentwithpaliperidoneER.There wassignificantimprovementinpatients’functionalityasmeasuredbyPSPimprovementandscorechanges. Concerningtheotherefficacyparameters,PANSStotalscale,PSPtotalscale,andsocialfunctioningtotalscaleat theendofstudyallindicatedstatisticallysignificantimprovementbycomparisonwithbaseline.Thesafetyprofile alsodemonst