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Treatment of patients with recently exacerbated schizophrenia with paliperidone palmitate: a pilot study of efficacy and tolerability

dc.creatorGattaz, Wagner F.es_ES
dc.creatorSaracco-Alvarez, Ricardoes_ES
dc.creatorSalles Daltio, Claudianees_ES
dc.creatorVan de Bilt, Martinus T.es_ES
dc.creatorOrtegón, Jose Julianes_ES
dc.creatorVillaseñor-Bayardo, Sergio J.es_ES
dc.creatorLouzã, Marioes_ES
dc.creatorElkis, Helioes_ES
dc.creatorSoares, Bernardoes_ES
dc.creatorCabrera Jaramillo, Patriciaes_ES
dc.creatorLawson, Fabioes_ES
dc.creatorDíaz-Galvis, Leonardoes_ES
dc.date2020
dc.date.accessioned2023-11-30T16:31:26Z
dc.date.available2023-11-30T16:31:26Z
dc.date.issued2020
dc.identifierJC17SIC20es_ES
dc.identifier.issn1176-6328
dc.identifier.urihttp://repositorio.inprf.gob.mx/handle/123456789/7845
dc.identifier.urihttps://doi.org/10.2147/NDT.S233537
dc.identifier.urihttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7490440/
dc.descriptionBackground: 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.es_ES
dc.formatPDFes_ES
dc.language.isoenges_ES
dc.publisherDove Medical Presses_ES
dc.relation16: 2063-2072
dc.rightsAcceso Cerradoes_ES
dc.titleTreatment of patients with recently exacerbated schizophrenia with paliperidone palmitate: a pilot study of efficacy and tolerabilityes_ES
dc.typeArtículoes_ES
dc.contributor.affiliationLaboratory of Neuroscience (LIM27), Instituto de Psiquiatria do Hospital das Clinicas da Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
dc.contributor.emailjldiaz01@its.jnj.com ( Leonardo Díaz-Galvis )
dc.relation.jnabreviadoNEUROPSYCHIATR DIS TREAT
dc.relation.journalNeuropsychiatric Disease and Treatment
dc.identifier.placeNueva Zelanda
dc.date.published2020
dc.identifier.organizacionInstituto Nacional de Psiquiatría Ramón de la Fuente Muñiz
dc.identifier.eissn1178-2021
dc.identifier.doi10.2147/NDT.S233537
dc.subject.kwPaliperidone palmitate
dc.subject.kwRecent onset
dc.subject.kwAcute phase
dc.subject.kwSchizophrenia


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