부산대학교 도서관

Purpose: To evaluate the differences in efficacy and safety outcomes in acute exacerbating schizophrenia patients between 2 subgroups ([less than or equal to]1 week and > 1 week), differing in time interval from hospitalization to time of initiation of once-monthly paliperidone palmitate. Patients and methods: PREVAIL was a multicenter, single-arm, open-label, prospective Phase IV study in hospitalized Asian patients (either sex, aged 18-65 years) diagnosed with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition). Change from baseline to week 13 in primary (Positive and Negative Syndrome Scale [PANSS] total score), secondary endpoints (PANSS responder rate, PANSS subscale, PANSS Marder factor, Clinical Global Impression-Severity, and Personal and Social Performance scale scores, readiness for hospital discharge questionnaire) and safety were assessed in this post hoc analysis. Results: Significant mean reduction from baseline to week 13 in the PANSS total score, 30% PANSS responder rates (P[less than or equal to]0.01), PANSS subscales (positive and general psychopathology; all P[less than or equal to]0.01), PANSS Marder factor (positive symptoms, uncontrolled hostility, and excitement and anxiety/depression; all P[less than or equal to]0.01), Personal and Social Performance scale scores (P[less than or equal to]0.05) and Clinical Global Impression-Severity categorical summary (P[less than or equal to]0.05) were significantly greater in the [less than or equal to] 1 week subgroup versus > 1 week subgroup (P[less than or equal to]0.05). The readiness for hospital discharge questionnaire improved over time for the overall study population, but remained similar between subgroups at all-time points. Treatment-emergent adverse events were similar between the subgroups. Conclusion: Early initiation of once-monthly paliperidone palmitate in hospitalized patients with acute exacerbation of schizophrenia led to greater improvements in psychotic symptoms with comparable safety than treatment initiation following 1 week of hospitalization. Keywords: early treatment initiation, hospital setting, long acting injectable, Asian, hospital discharge, efficacy, safety, positive and negative syndrome scale total score
Introduction Schizophrenia is a chronic, disabling illness with the potential for acute worsening of psychotic symptoms, thus requiring long-term treatment with antipsychotics for continuous disease control. (1) The clinical management [...]