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

Date
2008
Authors
Emsley R.
Berwaerts J.
Eerdekens M.
Kramer M.
Lane R.
Lim P.
Hough D.
Palumbo J.
Journal Title
Journal ISSN
Volume Title
Publisher
Abstract
Long-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.
Description
Keywords
olanzapine, paliperidone, adult, agitation, akathisia, akinesia, amenorrhea, anxiety, article, blepharospasm, bradkinesia, bradykinesia, chorea, controlled drug release, controlled study, depression, diabetes mellitus, dizziness, drug efficacy, drug metabolism, drug safety, drug tolerability, drug withdrawal, dyskinesia, dystonia, erectile dysfunction, extrapyramidal symptom, female, glabella, glabella reflex, glucose blood level, glucosuria, headache, human, hyperglycemia, hypersalivation, hypokinesia, insomnia, major clinical study, male, menstrual irregularity, muscle hypertonia, muscle rigidity, muscle spasm, muscle twitch, musculoskeletal stiffness, myoclonus, nausea, paerkinsonism, parkinsonism, priority journal, prolactin blood level, psychosis, rating scale, recommended drug dose, restless legs syndrome, rhinopharyngitis, schizophrenia, scoring system, side effect, sinus tachycardia, somnolence, suicide, tachycardia, tardive dyskinesia, treatment duration, treatment outcome, tremor, trismus, weight change, Acute Disease, Administration, Oral, Adult, Antipsychotic Agents, Clinical Trials as Topic, Delayed-Action Preparations, Female, Humans, Isoxazoles, Male, Middle Aged, Multicenter Studies as Topic, Psychiatric Status Rating Scales, Pyrimidines, Schizophrenia, Schizophrenic Psychology, Severity of Illness Index, Tablets, Time Factors, Treatment Outcome
Citation
International Clinical Psychopharmacology
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