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Asian Subgroup Analysis of the REMISSIO Study: A Long-Term Efficacy and Safety Study of Paliperidone Palmitate 3-month Formulation in Patients with Stable Schizophrenia in a Naturalistic Clinical Setting
OBJECTIVE: To evaluate the long-term efficacy and safety of three-monthly paliperidone palmitate (PP3M) in Asian patients with stable schizophrenia in a naturalistic setting. METHODS: Asian patients recruited between May 2016 and March 2018 from the prospective, single-arm, non-randomized, open-labe...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Korean College of Neuropsychopharmacology
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9329113/ https://www.ncbi.nlm.nih.gov/pubmed/35879027 http://dx.doi.org/10.9758/cpn.2022.20.3.427 |
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author | Chung, Young-Chul Yang, Yen Kuang Sulaiman, Ahmad Hatim Bergmans, Paul Tan, Wilson |
author_facet | Chung, Young-Chul Yang, Yen Kuang Sulaiman, Ahmad Hatim Bergmans, Paul Tan, Wilson |
author_sort | Chung, Young-Chul |
collection | PubMed |
description | OBJECTIVE: To evaluate the long-term efficacy and safety of three-monthly paliperidone palmitate (PP3M) in Asian patients with stable schizophrenia in a naturalistic setting. METHODS: Asian patients recruited between May 2016 and March 2018 from the prospective, single-arm, non-randomized, open-label, multi-national REMISSIO study were analyzed. Patients received PP3M over 12 months following ≥ 4 months of treatment with one-monthly paliperidone palmitate. The primary efficacy endpoint was the proportion of patients who achieved symptomatic remission. Other endpoints were changes in Positive and Negative Syndrome Scale (PANSS) and Personal and Social Performance (PSP) total scores, hospitalization rates, and safety. RESULTS: A total of 71 patients (23.3%) were Asian (South Korea 33, Malaysia 21, Taiwan 17); 95.8% of patients completed the study. At LOCF, 71% of Asian patients achieved symptomatic remission compared to the overall population (n = 172/303, 56.8%). Improvements in mean (standard deviation) PANSS and PSP total scores from baseline to LOCF in Asian patients and overall population were clinically significant. A lower proportion of Asian patients had ≥ 1 psychiatric hospitalization after PP3M treatment (n = 1/70, 1.4%) than during the 12 months before (n = 12/70, 17.1%); compared with patients in the overall population after (n = 8/303, 2.6%) and before PP3M treatment (n = 37/303, 12.2%). The overall incidence of treatment-emergent adverse events across Asian patients was 62.9% compared to 53.1% in the overall population. Safety findings were consistent with the known safety profile of PP3M. CONCLUSION: Our findings confirm existing evidence on the efficacy and tolerability of PP3M in Asian patients with stable schizophrenia over 12 months of treatment. |
format | Online Article Text |
id | pubmed-9329113 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Korean College of Neuropsychopharmacology |
record_format | MEDLINE/PubMed |
spelling | pubmed-93291132022-08-31 Asian Subgroup Analysis of the REMISSIO Study: A Long-Term Efficacy and Safety Study of Paliperidone Palmitate 3-month Formulation in Patients with Stable Schizophrenia in a Naturalistic Clinical Setting Chung, Young-Chul Yang, Yen Kuang Sulaiman, Ahmad Hatim Bergmans, Paul Tan, Wilson Clin Psychopharmacol Neurosci Original Article OBJECTIVE: To evaluate the long-term efficacy and safety of three-monthly paliperidone palmitate (PP3M) in Asian patients with stable schizophrenia in a naturalistic setting. METHODS: Asian patients recruited between May 2016 and March 2018 from the prospective, single-arm, non-randomized, open-label, multi-national REMISSIO study were analyzed. Patients received PP3M over 12 months following ≥ 4 months of treatment with one-monthly paliperidone palmitate. The primary efficacy endpoint was the proportion of patients who achieved symptomatic remission. Other endpoints were changes in Positive and Negative Syndrome Scale (PANSS) and Personal and Social Performance (PSP) total scores, hospitalization rates, and safety. RESULTS: A total of 71 patients (23.3%) were Asian (South Korea 33, Malaysia 21, Taiwan 17); 95.8% of patients completed the study. At LOCF, 71% of Asian patients achieved symptomatic remission compared to the overall population (n = 172/303, 56.8%). Improvements in mean (standard deviation) PANSS and PSP total scores from baseline to LOCF in Asian patients and overall population were clinically significant. A lower proportion of Asian patients had ≥ 1 psychiatric hospitalization after PP3M treatment (n = 1/70, 1.4%) than during the 12 months before (n = 12/70, 17.1%); compared with patients in the overall population after (n = 8/303, 2.6%) and before PP3M treatment (n = 37/303, 12.2%). The overall incidence of treatment-emergent adverse events across Asian patients was 62.9% compared to 53.1% in the overall population. Safety findings were consistent with the known safety profile of PP3M. CONCLUSION: Our findings confirm existing evidence on the efficacy and tolerability of PP3M in Asian patients with stable schizophrenia over 12 months of treatment. Korean College of Neuropsychopharmacology 2022-08-31 2022-08-31 /pmc/articles/PMC9329113/ /pubmed/35879027 http://dx.doi.org/10.9758/cpn.2022.20.3.427 Text en Copyright© 2022, Korean College of Neuropsychopharmacology https://creativecommons.org/licenses/by-nc/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0 (https://creativecommons.org/licenses/by-nc/4.0/) ) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article Chung, Young-Chul Yang, Yen Kuang Sulaiman, Ahmad Hatim Bergmans, Paul Tan, Wilson Asian Subgroup Analysis of the REMISSIO Study: A Long-Term Efficacy and Safety Study of Paliperidone Palmitate 3-month Formulation in Patients with Stable Schizophrenia in a Naturalistic Clinical Setting |
title | Asian Subgroup Analysis of the REMISSIO Study: A Long-Term Efficacy and Safety Study of Paliperidone Palmitate 3-month Formulation in Patients with Stable Schizophrenia in a Naturalistic Clinical Setting |
title_full | Asian Subgroup Analysis of the REMISSIO Study: A Long-Term Efficacy and Safety Study of Paliperidone Palmitate 3-month Formulation in Patients with Stable Schizophrenia in a Naturalistic Clinical Setting |
title_fullStr | Asian Subgroup Analysis of the REMISSIO Study: A Long-Term Efficacy and Safety Study of Paliperidone Palmitate 3-month Formulation in Patients with Stable Schizophrenia in a Naturalistic Clinical Setting |
title_full_unstemmed | Asian Subgroup Analysis of the REMISSIO Study: A Long-Term Efficacy and Safety Study of Paliperidone Palmitate 3-month Formulation in Patients with Stable Schizophrenia in a Naturalistic Clinical Setting |
title_short | Asian Subgroup Analysis of the REMISSIO Study: A Long-Term Efficacy and Safety Study of Paliperidone Palmitate 3-month Formulation in Patients with Stable Schizophrenia in a Naturalistic Clinical Setting |
title_sort | asian subgroup analysis of the remissio study: a long-term efficacy and safety study of paliperidone palmitate 3-month formulation in patients with stable schizophrenia in a naturalistic clinical setting |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9329113/ https://www.ncbi.nlm.nih.gov/pubmed/35879027 http://dx.doi.org/10.9758/cpn.2022.20.3.427 |
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