Protocolo Clínico e Diretrizes Terapêuticas (PCDT) complementares de esquizofrenia no Estado de Goiás - versão 2022 / Clinical protocol and complementary therapeutic guidelines (PCDT) for schizophrenia in the State of Goiás - version 2022

Protocolo estadual que complementa o PCDT do Ministério da Saúde e ambos devem ser considerados como referência diagnóstica e terapêutica pelos profissionais de saúde, em Goiás, para o tratamento de pessoas com o transtorno de esquizofrenia. A esquizofrenia é um transtorno mental grave que ocorre em cerca de 1% da população, independente de nível sociocultural. É caracterizada por períodos de intensas distorções do pensamento e da percepção (surtos) e pela inadequação e embotamento do afeto. Ao longo do tempo, pode aparecer prejuízos cognitivos em uma parcela significativa dos pacientes , principalmente os que não seguem tratamento regular

State protocol that complements the Ministry of Health's PCDT and both should be considered as a diagnostic and therapeutic reference by health professionals in Goiás for the treatment of people with schizophrenia disorder. Schizophrenia is a serious mental disorder that occurs in around 1% of the population, regardless of sociocultural level. It is characterized by periods of intense distortions of thought and perception (outbreaks) and by inadequacy and blunting of affect. Over time, cognitive impairment may appear in a significant portion of patients, especially those who do not follow regular treatment

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 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