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Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies

OBJECTIVE: To analyze the efficacy and safety of paliperidone palmitate 3-monthly (PP3M) in Latin American patients with schizophrenia vs. rest-of-world (ROW). METHODS: We analyzed data from two multinational, double-blind (DB), randomized, controlled phase 3 studies including patients with schizoph...

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Autores principales: Savitz, Adam J., Xu, Haiyan, Gopal, Srihari, Nuamah, Isaac, Mathews, Maju, Soares, Bernardo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Associação Brasileira de Psiquiatria 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6899357/
https://www.ncbi.nlm.nih.gov/pubmed/30994855
http://dx.doi.org/10.1590/1516-4446-2018-0153
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author Savitz, Adam J.
Xu, Haiyan
Gopal, Srihari
Nuamah, Isaac
Mathews, Maju
Soares, Bernardo
author_facet Savitz, Adam J.
Xu, Haiyan
Gopal, Srihari
Nuamah, Isaac
Mathews, Maju
Soares, Bernardo
author_sort Savitz, Adam J.
collection PubMed
description OBJECTIVE: To analyze the efficacy and safety of paliperidone palmitate 3-monthly (PP3M) in Latin American patients with schizophrenia vs. rest-of-world (ROW). METHODS: We analyzed data from two multinational, double-blind (DB), randomized, controlled phase 3 studies including patients with schizophrenia (DSM-IV-TR) previously stabilized on PP1M/PP3M (open-label [OL] phase). Patients were randomized to PP3M or PP1M (noninferiority study A) and PP3M or placebo (study B) in DB phase. The subgroup analysis included Latin American (Argentina, Brazil, Colombia, Mexico) patients. Primary efficacy endpoints were relapse-free rates (study A) and time-to-relapse (study B). RESULTS: In study A, 63/71 (88.7%) and in study B 38/43 (88.4%) Latin American patients completed the DB phase. In study A, relapse-free percentage was similar in Latin America (PP3M: 97%, PP1M: 100%) and ROW (PP3M: 91%, PP1M: 89%). In study B, median time-to-relapse was not estimable in the Latin American subgroup for either placebo or PP3M groups, nor for the ROW PP3M group; the median time-to-relapse in the ROW placebo group was 395 days. Caregiver burden improved in patients switching from oral antipsychotics (OL baseline) to PP3M/PP1M in DB phase (Involvement Evaluation Questionnaire score mean ± SD change, -9.4±15.16; p < 0.001). Treatment emergent adverse events with PP3M during DB phase were similar in Latin America (study A: 24/34 [70.6%]; study B: 15/21 [71.4%]) and ROW (study A: 318/470 [67.7%]; study B: 84/139 [60.4%]) subgroups. CONCLUSION: PP3M was efficacious and showed no new safety concerns in patients with schizophrenia from Latin America, corroborating ROW findings. CLINICAL TRIAL REGISTRATION: NCT01515423, NCT01529515
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spelling pubmed-68993572019-12-30 Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies Savitz, Adam J. Xu, Haiyan Gopal, Srihari Nuamah, Isaac Mathews, Maju Soares, Bernardo Braz J Psychiatry Original Article OBJECTIVE: To analyze the efficacy and safety of paliperidone palmitate 3-monthly (PP3M) in Latin American patients with schizophrenia vs. rest-of-world (ROW). METHODS: We analyzed data from two multinational, double-blind (DB), randomized, controlled phase 3 studies including patients with schizophrenia (DSM-IV-TR) previously stabilized on PP1M/PP3M (open-label [OL] phase). Patients were randomized to PP3M or PP1M (noninferiority study A) and PP3M or placebo (study B) in DB phase. The subgroup analysis included Latin American (Argentina, Brazil, Colombia, Mexico) patients. Primary efficacy endpoints were relapse-free rates (study A) and time-to-relapse (study B). RESULTS: In study A, 63/71 (88.7%) and in study B 38/43 (88.4%) Latin American patients completed the DB phase. In study A, relapse-free percentage was similar in Latin America (PP3M: 97%, PP1M: 100%) and ROW (PP3M: 91%, PP1M: 89%). In study B, median time-to-relapse was not estimable in the Latin American subgroup for either placebo or PP3M groups, nor for the ROW PP3M group; the median time-to-relapse in the ROW placebo group was 395 days. Caregiver burden improved in patients switching from oral antipsychotics (OL baseline) to PP3M/PP1M in DB phase (Involvement Evaluation Questionnaire score mean ± SD change, -9.4±15.16; p < 0.001). Treatment emergent adverse events with PP3M during DB phase were similar in Latin America (study A: 24/34 [70.6%]; study B: 15/21 [71.4%]) and ROW (study A: 318/470 [67.7%]; study B: 84/139 [60.4%]) subgroups. CONCLUSION: PP3M was efficacious and showed no new safety concerns in patients with schizophrenia from Latin America, corroborating ROW findings. CLINICAL TRIAL REGISTRATION: NCT01515423, NCT01529515 Associação Brasileira de Psiquiatria 2019-04-15 /pmc/articles/PMC6899357/ /pubmed/30994855 http://dx.doi.org/10.1590/1516-4446-2018-0153 Text en http://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, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Savitz, Adam J.
Xu, Haiyan
Gopal, Srihari
Nuamah, Isaac
Mathews, Maju
Soares, Bernardo
Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies
title Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies
title_full Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies
title_fullStr Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies
title_full_unstemmed Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies
title_short Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies
title_sort efficacy and safety of paliperidone palmitate 3-month formulation in latin american patients with schizophrenia: a subgroup analysis of data from two large phase 3 randomized, double-blind studies
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6899357/
https://www.ncbi.nlm.nih.gov/pubmed/30994855
http://dx.doi.org/10.1590/1516-4446-2018-0153
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