Efficacy and safety of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: Pooled data from three 52-week open-label studies

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dc.contributor.authorEmsley R.
dc.contributor.authorBerwaerts J.
dc.contributor.authorEerdekens M.
dc.contributor.authorKramer M.
dc.contributor.authorLane R.
dc.contributor.authorLim P.
dc.contributor.authorHough D.
dc.contributor.authorPalumbo J.
dc.date.accessioned2011-05-15T15:59:17Z
dc.date.available2011-05-15T15:59:17Z
dc.date.issued2008
dc.description.abstractLong-term efficacy and safety of paliperidone extended-release tablets (3-12 mg/day) were evaluated in pooled data from 52-week open-label extension (OLE) phases of three 6-week, placebo-controlled, double-blind (DB) trials involving 1083 schizophrenia patients. Forty-seven percent of patients completed the OLE phase. Outcome measures included Positive and Negative Syndrome Scale and Personal and Social Performance scale scores. Improvements observed on both scales in active treatment groups during the DB phases were maintained during the OLE phase. Most commonly (≥ 10% patients) reported adverse events (AEs) were insomnia, headache, and akathisia. One or more serious AEs were reported by 16% of patients; two patients had a treatment-emergent AE that resulted in death (suicide). Extrapyramidal symptom-related AEs were reported by 25% of patients. Median maximum movement disorder rating scale scores indicated no severity change during the OLE. Mean (± SD) increase in body weight from OLE baseline to end point was 1.1 ± 5.47 kg across treatment groups and there were no clinically meaningful changes for plasma glucose, insulin or lipid levels. This analysis shows that paliperidone extended-release can maintain improvements in symptoms and functioning and is generally well tolerated for up to 52 weeks in schizophrenia patients. © 2008 Wolters Kluwer Health | Lippincott Williams & Wilkins.
dc.description.versionArticle
dc.identifier.citationInternational Clinical Psychopharmacology
dc.identifier.citation23
dc.identifier.citation6
dc.identifier.issn2681315
dc.identifier.other10.1097/YIC.0b013e328314e1f3
dc.identifier.urihttp://hdl.handle.net/10019.1/11096
dc.subjectolanzapine
dc.subjectpaliperidone
dc.subjectadult
dc.subjectagitation
dc.subjectakathisia
dc.subjectakinesia
dc.subjectamenorrhea
dc.subjectanxiety
dc.subjectarticle
dc.subjectblepharospasm
dc.subjectbradkinesia
dc.subjectbradykinesia
dc.subjectchorea
dc.subjectcontrolled drug release
dc.subjectcontrolled study
dc.subjectdepression
dc.subjectdiabetes mellitus
dc.subjectdizziness
dc.subjectdrug efficacy
dc.subjectdrug metabolism
dc.subjectdrug safety
dc.subjectdrug tolerability
dc.subjectdrug withdrawal
dc.subjectdyskinesia
dc.subjectdystonia
dc.subjecterectile dysfunction
dc.subjectextrapyramidal symptom
dc.subjectfemale
dc.subjectglabella
dc.subjectglabella reflex
dc.subjectglucose blood level
dc.subjectglucosuria
dc.subjectheadache
dc.subjecthuman
dc.subjecthyperglycemia
dc.subjecthypersalivation
dc.subjecthypokinesia
dc.subjectinsomnia
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectmenstrual irregularity
dc.subjectmuscle hypertonia
dc.subjectmuscle rigidity
dc.subjectmuscle spasm
dc.subjectmuscle twitch
dc.subjectmusculoskeletal stiffness
dc.subjectmyoclonus
dc.subjectnausea
dc.subjectpaerkinsonism
dc.subjectparkinsonism
dc.subjectpriority journal
dc.subjectprolactin blood level
dc.subjectpsychosis
dc.subjectrating scale
dc.subjectrecommended drug dose
dc.subjectrestless legs syndrome
dc.subjectrhinopharyngitis
dc.subjectschizophrenia
dc.subjectscoring system
dc.subjectside effect
dc.subjectsinus tachycardia
dc.subjectsomnolence
dc.subjectsuicide
dc.subjecttachycardia
dc.subjecttardive dyskinesia
dc.subjecttreatment duration
dc.subjecttreatment outcome
dc.subjecttremor
dc.subjecttrismus
dc.subjectweight change
dc.subjectAcute Disease
dc.subjectAdministration, Oral
dc.subjectAdult
dc.subjectAntipsychotic Agents
dc.subjectClinical Trials as Topic
dc.subjectDelayed-Action Preparations
dc.subjectFemale
dc.subjectHumans
dc.subjectIsoxazoles
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectMulticenter Studies as Topic
dc.subjectPsychiatric Status Rating Scales
dc.subjectPyrimidines
dc.subjectSchizophrenia
dc.subjectSchizophrenic Psychology
dc.subjectSeverity of Illness Index
dc.subjectTablets
dc.subjectTime Factors
dc.subjectTreatment Outcome
dc.titleEfficacy and safety of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: Pooled data from three 52-week open-label studies
dc.typeArticle
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