Treatment of Patients with Recently Exacerbated Schizophrenia with Paliperidone Palmitate: A Pilot Study of Efficacy and Tolerability

Wagner F Gattaz,1 Ricardo Saracco-Alvarez,2 Claudiane Salles Daltio,3 Martinus T Van de Bilt,1 Jose Julian Ortegón,4 Sergio J Villaseñor-Bayardo,5 Mario Louzã,6 Helio Elkis,6 Bernardo Soares,7 Patricia Cabrera Jaramillo,7 Fabio Lawson,7 Leonardo Díaz-Galvi...

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Autores principales:	Gattaz WF, Saracco-Alvarez R, Daltio CS, Van de Bilt MT, Ortegón JJ, Villaseñor-Bayardo SJ, Louzã M, Elkis H, Soares B, Cabrera Jaramillo P, Lawson F, Díaz-Galvis L
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2020
Materias:	paliperidone palmitate recent onset acute phase schizophrenia Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/9d40cfb2bba94dbc9350b56f534bb09b
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id	oai:doaj.org-article:9d40cfb2bba94dbc9350b56f534bb09b
record_format	dspace
institution	DOAJ
collection	DOAJ
language	EN
topic	paliperidone palmitate recent onset acute phase schizophrenia Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	paliperidone palmitate recent onset acute phase schizophrenia Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Gattaz WF Saracco-Alvarez R Daltio CS Van de Bilt MT Ortegón JJ Villaseñor-Bayardo SJ Louzã M Elkis H Soares B Cabrera Jaramillo P Lawson F Díaz-Galvis L Treatment of Patients with Recently Exacerbated Schizophrenia with Paliperidone Palmitate: A Pilot Study of Efficacy and Tolerability
description	Wagner F Gattaz,1 Ricardo Saracco-Alvarez,2 Claudiane Salles Daltio,3 Martinus T Van de Bilt,1 Jose Julian Ortegón,4 Sergio J Villaseñor-Bayardo,5 Mario Louzã,6 Helio Elkis,6 Bernardo Soares,7 Patricia Cabrera Jaramillo,7 Fabio Lawson,7 Leonardo Díaz-Galvis8 1Laboratory of Neuroscience (LIM27), Instituto de Psiquiatria do Hospital das Clinicas da Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil; 2Instituto Nacional de Psiquiatría Ramón de la Fuentel, México D.F., México; 3Proesq - Unifesp Schizophrenia Program - Federal University of São Paulo, São Paulo, Brazil; 4Centro de Investigaciones del Sistema Nervioso, Grupo Cisne, Bogotá, Colombia; 5University of Guadalajara, Mexico, Hospital Civil de Guadalajara, “Fray Antonio Alcalde”, Guadalajara, Mexico; 6Instituto de Psiquiatria do HCFMUSP, São Paulo, Brazil; 7Medical Affairs, Janssen, Brazil; 8Medical Affairs, Janssen Canada, Toronto, ON, CanadaCorrespondence: Leonardo Díaz-GalvisDepartment of Medical Affairs, Janssen Inc, 19 Green Belt Dr, Toronto, ON M3C 1L9, CanadaTel +1 416 382 5020Email jldiaz01@its.jnj.comBackground: Paliperidone palmitate is a long-acting, second-generation antipsychotic (SGA) indicated for the treatment of acute exacerbations and maintenance treatment of adults with schizophrenia. This study addressed the response to paliperidone palmitate in Latin American patients with acute symptoms and recently diagnosed schizophrenia.Objective: Explore the efficacy and tolerability of paliperidone palmitate administered once a month for 4 months in patients with acute phase and recent diagnosis (within 1– 6 years) of schizophrenia in 3 Latin American countries.Methods: This was a non-randomized, open-label, multicenter study with paliperidone palmitate injected intramuscularly in the deltoid muscle at an initial loading dose of 150 mg eq. (234 mg) on day 1 and 100 mg eq. (156 mg) on day 8 (± 4 days). The recommended maintenance dose was 75 mg eq. (117 mg) from day 36 to day 92. Efficacy was evaluated with PANSS and CGI-S. The last observation carried forward (LOCF) was used for efficacy analysis for imputation of missing data; no adjustments were made for multiplicity. Adverse events were evaluated during treatment.Results: The patient retention rate was 84.0% (144 patients received study drug; 121 finished the study). The percentage of patients with a reduction of at least 30% in PANSS total score compared to baseline gradually increased during the study, and at the end, 78.4% of patients showed response. The PANSS total score and CGI-S scores decreased significantly from baseline to LOCF endpoint (P < 0.0001 for both); significant reduction in PANSS total score was observed at day 8 and persisted to the end of the study. Most common adverse events were muscle rigidity (11.8%), akathisia (11.1%), injection-site pain (7.6%), weight gain (7.6%), and insomnia (7.6%).Conclusion: Paliperidone palmitate was efficacious in Latin American patients studied with an acute exacerbation and recent diagnosis of schizophrenia, and no new safety signals were identified.Keywords: paliperidone palmitate, recent onset, acute phase, schizophrenia
format	article
author	Gattaz WF Saracco-Alvarez R Daltio CS Van de Bilt MT Ortegón JJ Villaseñor-Bayardo SJ Louzã M Elkis H Soares B Cabrera Jaramillo P Lawson F Díaz-Galvis L
author_facet	Gattaz WF Saracco-Alvarez R Daltio CS Van de Bilt MT Ortegón JJ Villaseñor-Bayardo SJ Louzã M Elkis H Soares B Cabrera Jaramillo P Lawson F Díaz-Galvis L
author_sort	Gattaz WF
title	Treatment of Patients with Recently Exacerbated Schizophrenia with Paliperidone Palmitate: A Pilot Study of Efficacy and Tolerability
title_short	Treatment of Patients with Recently Exacerbated Schizophrenia with Paliperidone Palmitate: A Pilot Study of Efficacy and Tolerability
title_full	Treatment of Patients with Recently Exacerbated Schizophrenia with Paliperidone Palmitate: A Pilot Study of Efficacy and Tolerability
title_fullStr	Treatment of Patients with Recently Exacerbated Schizophrenia with Paliperidone Palmitate: A Pilot Study of Efficacy and Tolerability
title_full_unstemmed	Treatment of Patients with Recently Exacerbated Schizophrenia with Paliperidone Palmitate: A Pilot Study of Efficacy and Tolerability
title_sort	treatment of patients with recently exacerbated schizophrenia with paliperidone palmitate: a pilot study of efficacy and tolerability
publisher	Dove Medical Press
publishDate	2020
url	https://doaj.org/article/9d40cfb2bba94dbc9350b56f534bb09b
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spelling	oai:doaj.org-article:9d40cfb2bba94dbc9350b56f534bb09b2021-12-02T10:09:46ZTreatment of Patients with Recently Exacerbated Schizophrenia with Paliperidone Palmitate: A Pilot Study of Efficacy and Tolerability1178-2021https://doaj.org/article/9d40cfb2bba94dbc9350b56f534bb09b2020-09-01T00:00:00Zhttps://www.dovepress.com/treatment-of-patients-with-recently-exacerbated-schizophrenia-with-pal-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Wagner F Gattaz,1 Ricardo Saracco-Alvarez,2 Claudiane Salles Daltio,3 Martinus T Van de Bilt,1 Jose Julian Ortegón,4 Sergio J Villaseñor-Bayardo,5 Mario Louzã,6 Helio Elkis,6 Bernardo Soares,7 Patricia Cabrera Jaramillo,7 Fabio Lawson,7 Leonardo Díaz-Galvis8 1Laboratory of Neuroscience (LIM27), Instituto de Psiquiatria do Hospital das Clinicas da Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil; 2Instituto Nacional de Psiquiatría Ramón de la Fuentel, México D.F., México; 3Proesq - Unifesp Schizophrenia Program - Federal University of São Paulo, São Paulo, Brazil; 4Centro de Investigaciones del Sistema Nervioso, Grupo Cisne, Bogotá, Colombia; 5University of Guadalajara, Mexico, Hospital Civil de Guadalajara, “Fray Antonio Alcalde”, Guadalajara, Mexico; 6Instituto de Psiquiatria do HCFMUSP, São Paulo, Brazil; 7Medical Affairs, Janssen, Brazil; 8Medical Affairs, Janssen Canada, Toronto, ON, CanadaCorrespondence: Leonardo Díaz-GalvisDepartment of Medical Affairs, Janssen Inc, 19 Green Belt Dr, Toronto, ON M3C 1L9, CanadaTel +1 416 382 5020Email jldiaz01@its.jnj.comBackground: Paliperidone palmitate is a long-acting, second-generation antipsychotic (SGA) indicated for the treatment of acute exacerbations and maintenance treatment of adults with schizophrenia. This study addressed the response to paliperidone palmitate in Latin American patients with acute symptoms and recently diagnosed schizophrenia.Objective: Explore the efficacy and tolerability of paliperidone palmitate administered once a month for 4 months in patients with acute phase and recent diagnosis (within 1– 6 years) of schizophrenia in 3 Latin American countries.Methods: This was a non-randomized, open-label, multicenter study with paliperidone palmitate injected intramuscularly in the deltoid muscle at an initial loading dose of 150 mg eq. (234 mg) on day 1 and 100 mg eq. (156 mg) on day 8 (± 4 days). The recommended maintenance dose was 75 mg eq. (117 mg) from day 36 to day 92. Efficacy was evaluated with PANSS and CGI-S. The last observation carried forward (LOCF) was used for efficacy analysis for imputation of missing data; no adjustments were made for multiplicity. Adverse events were evaluated during treatment.Results: The patient retention rate was 84.0% (144 patients received study drug; 121 finished the study). The percentage of patients with a reduction of at least 30% in PANSS total score compared to baseline gradually increased during the study, and at the end, 78.4% of patients showed response. The PANSS total score and CGI-S scores decreased significantly from baseline to LOCF endpoint (P < 0.0001 for both); significant reduction in PANSS total score was observed at day 8 and persisted to the end of the study. Most common adverse events were muscle rigidity (11.8%), akathisia (11.1%), injection-site pain (7.6%), weight gain (7.6%), and insomnia (7.6%).Conclusion: Paliperidone palmitate was efficacious in Latin American patients studied with an acute exacerbation and recent diagnosis of schizophrenia, and no new safety signals were identified.Keywords: paliperidone palmitate, recent onset, acute phase, schizophreniaGattaz WFSaracco-Alvarez RDaltio CSVan de Bilt MTOrtegón JJVillaseñor-Bayardo SJLouzã MElkis HSoares BCabrera Jaramillo PLawson FDíaz-Galvis LDove Medical Pressarticlepaliperidone palmitaterecent onsetacute phaseschizophreniaNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 16, Pp 2063-2072 (2020)

Treatment of Patients with Recently Exacerbated Schizophrenia with Paliperidone Palmitate: A Pilot Study of Efficacy and Tolerability

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