| アブストラクト | INTRODUCTION: Paliperidone Palmitate is the only antipsychotic that has been developed in three different intramuscular long-acting injectable (LAI) dosing regimen: monthly (PP1M), quarterly (PP3M), and from 2020 also twice-yearly (PP6M). The latter was approved for the maintenance treatment of adults with schizophrenia and clinically stabilized with PP1M or PP3M. AREAS COVERED: Data from studies evaluating efficacy in the maintenance treatment of schizophrenia with PP6M are reviewed. Since no post-marketing safety studies are currently available, data from spontaneous reporting system databases, FAERS and Eudravigilance, are analyzed and the reported treatment-emergent adverse events of PP6M are discussed. EXPERT OPINION: The efficacy of PP6M is comparable to that of PP3M in terms of relapses prevention in patients with schizophrenia previously stabilized on PP3M or PP1M. Also, the maintenance of clinical efficacy in the long term has been demonstrated. Data from pharmacovigilance analyses, as well as from phase 3 studies, show that PP6M is generally well tolerated, consistently with PP3M safety data. PP6M allows a longer dosing interval than any other LAI antipsychotics, potentially reducing nonadherence and disease relapses. In future, an increase in the prescription rates of PP6M is expected and real-world efficacy and tolerability studies will be conducted. |
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| ジャーナル名 | Expert review of neurotherapeutics |
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| 投稿日 | 2024/3/6 |
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| 投稿者 | Cirnigliaro, Giovanna; Battini, Vera; Castiglioni, Michele; Renne, Marica; Mosini, Giulia; Cheli, Stefania; Carnovale, Carla; Dell'Osso, Bernardo |
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| 組織名 | Department of Biomedical and Clinical Sciences (DIBIC), Department of Psychiatry,;ASST Fatebenefratelli-Sacco, University of Milan, Milan, Italy.;Pharmacovigilance & Clinical Research, International Centre for Pesticides and;Health Risk Prevention, Department of Biomedical and Clinical Sciences (DIBIC),;ASST Fatebenefratelli-Sacco University Hospital, Universita degli Studi di;Milano, Milan, Italy.;Department of Psychiatry and Behavioral Sciences, Bipolar Disorders Clinic,;Stanford Medical School, Stanford University, Stanford, CA, USA.;CRC "Aldo Ravelli" for Neurotechnology & Experimental Brain Therapeutics,;University of Milan, Milan, Italy.;Centro per lo studio dei meccanismi molecolari alla base delle patologie;neuro-psico-geriatriche, Universita degli Studi di Milano, Milan, Italy. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38445396/ |
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