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Paliperidone Extended-Release for the Treatment of Schizophrenia
Paliperidone, the major active metabolite of risperidone (9‐hydroxy‐risperidone), is a second‐generation antipsychotic that was recently approved by the United States Food and Drug Administration for treatment of acute schizophrenia and for maintenance treatment of schizophrenia. We performed a lite...
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Published in: | Pharmacotherapy 2008-10, Vol.28 (10), p.1283-1298 |
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description | Paliperidone, the major active metabolite of risperidone (9‐hydroxy‐risperidone), is a second‐generation antipsychotic that was recently approved by the United States Food and Drug Administration for treatment of acute schizophrenia and for maintenance treatment of schizophrenia. We performed a literature search of PreMEDLINE, MEDLINE, and International Pharmaceutical s from 1966‐October 2007 to review the available data on the pharmacology, pharmacokinetics, clinical evidence, and safety and tolerability profile of paliperidone extended‐release (ER). Articles from randomized controlled trials, s, and posters presented at national scientific meetings were included in this review. Paliperidone ER has been shown to be significantly more effective in improving schizophrenic symptoms according to the Positive and Negative Symptom Scale (PANSS), Clinical Global Impressions‐Severity Scale, and Personal and Social Performance Scale compared with placebo (p |
doi_str_mv | 10.1592/phco.28.10.1283 |
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We performed a literature search of PreMEDLINE, MEDLINE, and International Pharmaceutical s from 1966‐October 2007 to review the available data on the pharmacology, pharmacokinetics, clinical evidence, and safety and tolerability profile of paliperidone extended‐release (ER). Articles from randomized controlled trials, s, and posters presented at national scientific meetings were included in this review. Paliperidone ER has been shown to be significantly more effective in improving schizophrenic symptoms according to the Positive and Negative Symptom Scale (PANSS), Clinical Global Impressions‐Severity Scale, and Personal and Social Performance Scale compared with placebo (p<0.05). In addition, limited evidence suggests similar efficacy between paliperidone ER 6–12 mg/day and risperidone 4–6 mg/day. A 2‐week, double‐blind comparison with quetiapine demonstrated that paliperidone ER was significantly better than quetiapine in improving PANSS scores (p<0.001). Paliperidone ER appears to be well tolerated at the recommended starting dosage of 6 mg/day. The most commonly reported adverse effect was dose‐related extrapyramidal symptoms. Weight gain and metabolic disturbances were minimal. The cost of paliperidone ER appears to be slightly higher than that of other second‐generation antipsychotics. Paliperidone ER tablets may be a safe and effective treatment option for acute schizophrenia and maintenance treatment of schizophrenia compared with placebo. Because well‐designed comparative data are lacking, an additional benefit over other antipsychotics is yet to be determined.</description><identifier>ISSN: 0277-0008</identifier><identifier>EISSN: 1875-9114</identifier><identifier>DOI: 10.1592/phco.28.10.1283</identifier><identifier>PMID: 18823223</identifier><identifier>CODEN: PHPYDQ</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>9-OH risperidone ; acute ; Acute Disease ; Adult and adolescent clinical studies ; Antipsychotic Agents - adverse effects ; Antipsychotic Agents - pharmacology ; Antipsychotic Agents - therapeutic use ; Biological and medical sciences ; cost ; Delayed-Action Preparations ; Drug Interactions ; extended-release tablets ; Fees, Pharmaceutical ; Humans ; Isoxazoles - adverse effects ; Isoxazoles - pharmacology ; Isoxazoles - therapeutic use ; maintenance ; Medical sciences ; paliperidone ; Paliperidone Palmitate ; Pharmacology. Drug treatments ; Psychology. Psychoanalysis. Psychiatry ; Psychopathology. Psychiatry ; Psychoses ; Pyrimidines - adverse effects ; Pyrimidines - pharmacology ; Pyrimidines - therapeutic use ; safety ; Schizophrenia ; Schizophrenia - drug therapy ; tolerability</subject><ispartof>Pharmacotherapy, 2008-10, Vol.28 (10), p.1283-1298</ispartof><rights>2008 Pharmacotherapy Publications Inc.</rights><rights>2008 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4089-cf15d83737c3dd8d30c9174d426cf427eef9ad5736daa1f773cf16178825488f3</citedby><cites>FETCH-LOGICAL-c4089-cf15d83737c3dd8d30c9174d426cf427eef9ad5736daa1f773cf16178825488f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20714270$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18823223$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Marino, Jehan</creatorcontrib><creatorcontrib>Caballero, Joshua</creatorcontrib><title>Paliperidone Extended-Release for the Treatment of Schizophrenia</title><title>Pharmacotherapy</title><addtitle>Pharmacotherapy</addtitle><description>Paliperidone, the major active metabolite of risperidone (9‐hydroxy‐risperidone), is a second‐generation antipsychotic that was recently approved by the United States Food and Drug Administration for treatment of acute schizophrenia and for maintenance treatment of schizophrenia. We performed a literature search of PreMEDLINE, MEDLINE, and International Pharmaceutical s from 1966‐October 2007 to review the available data on the pharmacology, pharmacokinetics, clinical evidence, and safety and tolerability profile of paliperidone extended‐release (ER). Articles from randomized controlled trials, s, and posters presented at national scientific meetings were included in this review. Paliperidone ER has been shown to be significantly more effective in improving schizophrenic symptoms according to the Positive and Negative Symptom Scale (PANSS), Clinical Global Impressions‐Severity Scale, and Personal and Social Performance Scale compared with placebo (p<0.05). In addition, limited evidence suggests similar efficacy between paliperidone ER 6–12 mg/day and risperidone 4–6 mg/day. A 2‐week, double‐blind comparison with quetiapine demonstrated that paliperidone ER was significantly better than quetiapine in improving PANSS scores (p<0.001). Paliperidone ER appears to be well tolerated at the recommended starting dosage of 6 mg/day. The most commonly reported adverse effect was dose‐related extrapyramidal symptoms. Weight gain and metabolic disturbances were minimal. The cost of paliperidone ER appears to be slightly higher than that of other second‐generation antipsychotics. Paliperidone ER tablets may be a safe and effective treatment option for acute schizophrenia and maintenance treatment of schizophrenia compared with placebo. Because well‐designed comparative data are lacking, an additional benefit over other antipsychotics is yet to be determined.</description><subject>9-OH risperidone</subject><subject>acute</subject><subject>Acute Disease</subject><subject>Adult and adolescent clinical studies</subject><subject>Antipsychotic Agents - adverse effects</subject><subject>Antipsychotic Agents - pharmacology</subject><subject>Antipsychotic Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>cost</subject><subject>Delayed-Action Preparations</subject><subject>Drug Interactions</subject><subject>extended-release tablets</subject><subject>Fees, Pharmaceutical</subject><subject>Humans</subject><subject>Isoxazoles - adverse effects</subject><subject>Isoxazoles - pharmacology</subject><subject>Isoxazoles - therapeutic use</subject><subject>maintenance</subject><subject>Medical sciences</subject><subject>paliperidone</subject><subject>Paliperidone Palmitate</subject><subject>Pharmacology. Drug treatments</subject><subject>Psychology. Psychoanalysis. Psychiatry</subject><subject>Psychopathology. Psychiatry</subject><subject>Psychoses</subject><subject>Pyrimidines - adverse effects</subject><subject>Pyrimidines - pharmacology</subject><subject>Pyrimidines - therapeutic use</subject><subject>safety</subject><subject>Schizophrenia</subject><subject>Schizophrenia - drug therapy</subject><subject>tolerability</subject><issn>0277-0008</issn><issn>1875-9114</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><recordid>eNqFkElPwzAQRi0EgrKcuaFcOKb1ksTOjUXQAhVULIKbZeyxEkiTyA6i5dfjkgqOnEYjvTfLh9AhwUOS5nTUFroZUjFc9VSwDTQggqdxTkiyiQaYch5jjMUO2vX-DWNKsoRuox0iBGWUsgE6mamqbMGVpqkhulh0UBsw8T1UoDxEtnFRV0D06EB1c6i7qLHRgy7Kr6YtHNSl2kdbVlUeDtZ1Dz1dXjyeT-Lp3fjq_HQa6wSLPNaWpEYwzrhmxgjDsM4JT0xCM20TygFsrkzKWWaUIpZzFoyM8HBomghh2R4a9XO1a7x3YGXryrlyS0mwXGUhV1lIKn76kEUwjnqj_Xidg_nj188H4HgNKK9VZZ2qdel_OYo5CZfhwCU991lWsPxvr5xNTu9Zngct7rXSd7D41ZR7l1nIIZXPt2OZPk9frtMbLs_YNzoRhuI</recordid><startdate>200810</startdate><enddate>200810</enddate><creator>Marino, Jehan</creator><creator>Caballero, Joshua</creator><general>Blackwell Publishing Ltd</general><general>Pharmacotherapy</general><scope>BSCLL</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>200810</creationdate><title>Paliperidone Extended-Release for the Treatment of Schizophrenia</title><author>Marino, Jehan ; Caballero, Joshua</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4089-cf15d83737c3dd8d30c9174d426cf427eef9ad5736daa1f773cf16178825488f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>9-OH risperidone</topic><topic>acute</topic><topic>Acute Disease</topic><topic>Adult and adolescent clinical studies</topic><topic>Antipsychotic Agents - adverse effects</topic><topic>Antipsychotic Agents - pharmacology</topic><topic>Antipsychotic Agents - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>cost</topic><topic>Delayed-Action Preparations</topic><topic>Drug Interactions</topic><topic>extended-release tablets</topic><topic>Fees, Pharmaceutical</topic><topic>Humans</topic><topic>Isoxazoles - adverse effects</topic><topic>Isoxazoles - pharmacology</topic><topic>Isoxazoles - therapeutic use</topic><topic>maintenance</topic><topic>Medical sciences</topic><topic>paliperidone</topic><topic>Paliperidone Palmitate</topic><topic>Pharmacology. Drug treatments</topic><topic>Psychology. Psychoanalysis. Psychiatry</topic><topic>Psychopathology. Psychiatry</topic><topic>Psychoses</topic><topic>Pyrimidines - adverse effects</topic><topic>Pyrimidines - pharmacology</topic><topic>Pyrimidines - therapeutic use</topic><topic>safety</topic><topic>Schizophrenia</topic><topic>Schizophrenia - drug therapy</topic><topic>tolerability</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Marino, Jehan</creatorcontrib><creatorcontrib>Caballero, Joshua</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Pharmacotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Marino, Jehan</au><au>Caballero, Joshua</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Paliperidone Extended-Release for the Treatment of Schizophrenia</atitle><jtitle>Pharmacotherapy</jtitle><addtitle>Pharmacotherapy</addtitle><date>2008-10</date><risdate>2008</risdate><volume>28</volume><issue>10</issue><spage>1283</spage><epage>1298</epage><pages>1283-1298</pages><issn>0277-0008</issn><eissn>1875-9114</eissn><coden>PHPYDQ</coden><abstract>Paliperidone, the major active metabolite of risperidone (9‐hydroxy‐risperidone), is a second‐generation antipsychotic that was recently approved by the United States Food and Drug Administration for treatment of acute schizophrenia and for maintenance treatment of schizophrenia. We performed a literature search of PreMEDLINE, MEDLINE, and International Pharmaceutical s from 1966‐October 2007 to review the available data on the pharmacology, pharmacokinetics, clinical evidence, and safety and tolerability profile of paliperidone extended‐release (ER). Articles from randomized controlled trials, s, and posters presented at national scientific meetings were included in this review. Paliperidone ER has been shown to be significantly more effective in improving schizophrenic symptoms according to the Positive and Negative Symptom Scale (PANSS), Clinical Global Impressions‐Severity Scale, and Personal and Social Performance Scale compared with placebo (p<0.05). In addition, limited evidence suggests similar efficacy between paliperidone ER 6–12 mg/day and risperidone 4–6 mg/day. A 2‐week, double‐blind comparison with quetiapine demonstrated that paliperidone ER was significantly better than quetiapine in improving PANSS scores (p<0.001). Paliperidone ER appears to be well tolerated at the recommended starting dosage of 6 mg/day. The most commonly reported adverse effect was dose‐related extrapyramidal symptoms. Weight gain and metabolic disturbances were minimal. The cost of paliperidone ER appears to be slightly higher than that of other second‐generation antipsychotics. Paliperidone ER tablets may be a safe and effective treatment option for acute schizophrenia and maintenance treatment of schizophrenia compared with placebo. Because well‐designed comparative data are lacking, an additional benefit over other antipsychotics is yet to be determined.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>18823223</pmid><doi>10.1592/phco.28.10.1283</doi><tpages>16</tpages></addata></record> |
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subjects | 9-OH risperidone acute Acute Disease Adult and adolescent clinical studies Antipsychotic Agents - adverse effects Antipsychotic Agents - pharmacology Antipsychotic Agents - therapeutic use Biological and medical sciences cost Delayed-Action Preparations Drug Interactions extended-release tablets Fees, Pharmaceutical Humans Isoxazoles - adverse effects Isoxazoles - pharmacology Isoxazoles - therapeutic use maintenance Medical sciences paliperidone Paliperidone Palmitate Pharmacology. Drug treatments Psychology. Psychoanalysis. Psychiatry Psychopathology. Psychiatry Psychoses Pyrimidines - adverse effects Pyrimidines - pharmacology Pyrimidines - therapeutic use safety Schizophrenia Schizophrenia - drug therapy tolerability |
title | Paliperidone Extended-Release for the Treatment of Schizophrenia |
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