Role of 3-monthly long-acting injectable paliperidone in the maintenance of schizophrenia

Claudio Brasso, Silvio Bellino, Paola Bozzatello, Cristiana Montemagni, Paola Rocca Department of Neurosciences “Rita Levi Montalcini”, University of Turin, Turin, Italy Aims: Paliperidone palmitate 3-month (PP3M) represents a new long-acting injectable antipsychotic therapeuti...

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Autores principales:	Brasso C, Bellino S, Bozzatello P, Montemagni C, Rocca P
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2017
Materias:	PP3M paliperidone palmitate long-acting antipsychotics schizophrenia efficacy safety Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/d415268b471b4f449e3ef95504a3d5bb
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spelling	oai:doaj.org-article:d415268b471b4f449e3ef95504a3d5bb2021-12-02T00:21:39ZRole of 3-monthly long-acting injectable paliperidone in the maintenance of schizophrenia1178-2021https://doaj.org/article/d415268b471b4f449e3ef95504a3d5bb2017-11-01T00:00:00Zhttps://www.dovepress.com/role-of-3-monthly-long-acting-injectable-paliperidone-in-the-maintenan-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Claudio Brasso, Silvio Bellino, Paola Bozzatello, Cristiana Montemagni, Paola Rocca Department of Neurosciences “Rita Levi Montalcini”, University of Turin, Turin, Italy Aims: Paliperidone palmitate 3-month (PP3M) represents a new long-acting injectable antipsychotic therapeutic option. This review aims: 1) to summarize available data relating to efficacy, safety, tolerability and costs of PP3M; 2) to describe hospitalization rate, occupational status, treatment preference, satisfaction, adherence and caregiver burden of patients with schizophrenia who participate in PP3M clinical trials; 3) to examine ethical implications, pros and cons of PP3M use and 4) to propose study designs to further assess PP3M.Methods: On August 21, 2017, a search on PubMed about PPM3, without any filter restriction, was conducted and all available records were analyzed. Records written in a language other than English were excluded.Results: Twenty-two records were included in this review: 6 reviews, 1 report, 4 pharmacokinetic studies, 2 cost-effectiveness analyses, 1 open-label clinical trial, 2 randomized controlled trials (RCTs), 5 studies based on these 2 RCTs and 1 observational study.Discussion: According to these last 9 studies, when compared with placebo, PP3M showed a longer time to relapse and good safety and tolerability profiles. Furthermore, when compared with paliperidone palmitate 1 month (PP1M), PP3M treatment showed: 1) non-inferiority in terms of efficacy, safety, tolerability, rate of hospitalization, symptomatic and functional remission, treatment preference and variations of the occupational status; 2) a longer time to relapse after treatment discontinuation and 3) a similar reduction of the caregiver burden.Conclusion: PP3M is the only 3-monthly long-acting injectable antipsychotic available on the market. This makes it a unique option of treatment, which could be chosen both in early and advanced phases of illness. Nonetheless, longer naturalistic follow-up studies, two-arm head-to-head superiority trials and mirror studies, based on real-world samples of patients, are needed to further assess long-term safety and advantages of this new option of treatment and to define patients’ sub-populations that would most beneficiate from it. Keywords: PP3M, paliperidone palmitate, LAI, antipsychotic, clinical assessment, advantages and disadvantagesBrasso CBellino SBozzatello PMontemagni CRocca PDove Medical PressarticlePP3Mpaliperidone palmitatelong-acting antipsychoticsschizophreniaefficacysafetyNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 13, Pp 2767-2779 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	PP3M paliperidone palmitate long-acting antipsychotics schizophrenia efficacy safety Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	PP3M paliperidone palmitate long-acting antipsychotics schizophrenia efficacy safety Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Brasso C Bellino S Bozzatello P Montemagni C Rocca P Role of 3-monthly long-acting injectable paliperidone in the maintenance of schizophrenia
description	Claudio Brasso, Silvio Bellino, Paola Bozzatello, Cristiana Montemagni, Paola Rocca Department of Neurosciences “Rita Levi Montalcini”, University of Turin, Turin, Italy Aims: Paliperidone palmitate 3-month (PP3M) represents a new long-acting injectable antipsychotic therapeutic option. This review aims: 1) to summarize available data relating to efficacy, safety, tolerability and costs of PP3M; 2) to describe hospitalization rate, occupational status, treatment preference, satisfaction, adherence and caregiver burden of patients with schizophrenia who participate in PP3M clinical trials; 3) to examine ethical implications, pros and cons of PP3M use and 4) to propose study designs to further assess PP3M.Methods: On August 21, 2017, a search on PubMed about PPM3, without any filter restriction, was conducted and all available records were analyzed. Records written in a language other than English were excluded.Results: Twenty-two records were included in this review: 6 reviews, 1 report, 4 pharmacokinetic studies, 2 cost-effectiveness analyses, 1 open-label clinical trial, 2 randomized controlled trials (RCTs), 5 studies based on these 2 RCTs and 1 observational study.Discussion: According to these last 9 studies, when compared with placebo, PP3M showed a longer time to relapse and good safety and tolerability profiles. Furthermore, when compared with paliperidone palmitate 1 month (PP1M), PP3M treatment showed: 1) non-inferiority in terms of efficacy, safety, tolerability, rate of hospitalization, symptomatic and functional remission, treatment preference and variations of the occupational status; 2) a longer time to relapse after treatment discontinuation and 3) a similar reduction of the caregiver burden.Conclusion: PP3M is the only 3-monthly long-acting injectable antipsychotic available on the market. This makes it a unique option of treatment, which could be chosen both in early and advanced phases of illness. Nonetheless, longer naturalistic follow-up studies, two-arm head-to-head superiority trials and mirror studies, based on real-world samples of patients, are needed to further assess long-term safety and advantages of this new option of treatment and to define patients’ sub-populations that would most beneficiate from it. Keywords: PP3M, paliperidone palmitate, LAI, antipsychotic, clinical assessment, advantages and disadvantages
format	article
author	Brasso C Bellino S Bozzatello P Montemagni C Rocca P
author_facet	Brasso C Bellino S Bozzatello P Montemagni C Rocca P
author_sort	Brasso C
title	Role of 3-monthly long-acting injectable paliperidone in the maintenance of schizophrenia
title_short	Role of 3-monthly long-acting injectable paliperidone in the maintenance of schizophrenia
title_full	Role of 3-monthly long-acting injectable paliperidone in the maintenance of schizophrenia
title_fullStr	Role of 3-monthly long-acting injectable paliperidone in the maintenance of schizophrenia
title_full_unstemmed	Role of 3-monthly long-acting injectable paliperidone in the maintenance of schizophrenia
title_sort	role of 3-monthly long-acting injectable paliperidone in the maintenance of schizophrenia
publisher	Dove Medical Press
publishDate	2017
url	https://doaj.org/article/d415268b471b4f449e3ef95504a3d5bb
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Role of 3-monthly long-acting injectable paliperidone in the maintenance of schizophrenia

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