Tolerability, Safety and Effectiveness of Paliperidone ER in Patients with Schizophrenia : A 24-Week Interim Analysis of the 48-Week Open-Label, Prospective, Switch Study

OBJECTIVES: We investigated the tolerability, safety, and treatment response to flexible-dose paliperidone ER in patients with non-acute schizophrenia in whom previous antipsychotic drugs were ineffective. METHODS: This 24-week interim analysis of the 48-week multicenter, prospective, open-label study assessed effectiveness using the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression-Schizophrenia-Severity (CGI-SCH-S) Scale, Personal and Social Performance (PSP) and Drug Attitude Inventory (DAI). Safety and tolerability were assessed using the Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) and Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS). RESULTS: Effectiveness was assessed in 169 patients. Significant improvement in the PANSS total score was observed by week-1 and continued until week-24. The response rate was 33%. The CGI-SCH-S and PSP total scores significantly improved during 24 weeks ; however, no change occurred in the total DAI. Fifty-nine percent of patients reported adverse events, of which extrapyramidal symptoms were the most frequent (19.0%). The DIEPSS and LUNSERS scores were improved after 24 week. CONCLUSIONS: Switching to the flexible-dose paliperidone ER from an ineffective antipsychotic drug was safe, tolerable, and showed a good treatment response in Korean patients with schizophrenia.

Influencing Factors and Predictors of Early Response in Schizophrenia Patients Receiving the Paliperidone Extended-Release Tablets (Paliperidone ER)

OBJECTIVE: Paliperidone extended-release tablet (paliperidone ER) is a new oral psychotropic agent developed for schizophrenia treatment. There have been some studies about paliperidone's good efficacy and tolerability. Clinicians appear to change the antipsychotic medication to paliperidone ER. However, it is not known what patients are favorable responsive to paliperidone ER. The aim of this study was to evaluate the characteristics of early responders and investigate predictors of acute response when the medications changed to paliperidone ER. METHODS: Data were analyzed from schizophrenic patients who participated in a multi-center, open-label, non-comparative clinical trial. Total 320 patients were examined in this study. Sociodemographic, psychopathology, social function and metabolic data were evaluated. Unpaired t-test for continuous and chi2 for categorical data, respectively, were used to compare early responder and non-responders. Logistic regression analysis was used to establish a prediction model. RESULTS: 38.7% of study subjects (124 of 320) responded to paliperidone ER treatment. Logistic regression analysis showed that a good paliperidone ER response was more likely when patients were social drinkers, when patients had started medication at inpatient, when negative symptoms were less severe, and when patients' social relationship and self-care were better. CONCLUSION: Early response to paliperidone ER treatment is associated with less negative symptoms and good social relationships and self-care. Strategies to reduce these symptoms may contribute to early response to paliperidone ER.

An Open Label Multi-Center Prospective Observational Study of Paliperidone Extended Release to Assess the Medication Satisfaction and Treatment Response in Patients with Schizophrenia / 대한정신약물학회지

OBJECTIVE: The aim of this study was to demonstrate changes of subjective medication satisfaction and clinical benefit after once-daily paliperidone extended release (ER) in treatment of schizophrenia. METHODS: In an open-label, observational, and multicenter study, 374 patients with schizophrenia who switched to paliperidone ER due to any reason were recruited. Medication Satisfaction Questionnaire (MSQ), Clinical Global Impression-Severity (CGI-S), Clinical Global Impression-Improvement and visual analogue scale for sleep (VAS) were assessed at baseline, 4 weeks and 8 weeks after treatment. We also examined the type, frequency, and severity of adverse events newly formed. RESULTS: Among 374 patients, 320 patients (76.5%) were included in the intent-to-treat analysis set. The mean dose of paliperidone ER was 5.33+/-2.31 mg/day at the initiation. At the endpoint, the mean dose of paliperidone ER was 6.68+/-3.13 mg/day. The percentages of patients satisfied with medication were changed from 40.9% at baseline to 67.8% at endpoint (p<0.001). Both CGI-S scores and VAS for daytime drowsiness were significantly decreased after 8 weeks (both p<0.0001) and mean scores of MSQ and VAS for sleep quality were improved after 8 weeks (both p<0.0001). CONCLUSION: After switching to paliperidone ER, 67.8% of patients with schizophrenia who had any reason to switch medication showed subjective satisfaction for medication and clinical improvement without significant adverse events. Regarding that medication satisfaction was associated with changes of clinical states, medication satisfaction can be used for measures for clinical scales in the treatment of schizophrenia.

Efficacy and Safety of Paliperidone Extended Release in Schizophrenia Patients Requiring a Switch in Antipsychotic Medication by Switching Previous Antipsychotics to Paliperidone Extended Release / 대한정신약물학회지

OBJECTIVE: This study aimed to evaluate the clinical efficacy, safety, and tolerability of paliperidone extended release (ER) in patients with schizophrenia by switching previous antipsychotics to paliperidone ER. METHODS: An open-label, 24 weeks, prospective, non-comparative, multi-center study evaluated total 387 patients with schizophrenia requiring a switch in antipsychotic medication due to suboptimal efficacy, intolerability, and non-compliance. Patients were switched to flexible-dose trial of paliperidone ER (3-12 mg/day). Efficacy was measured by Krawiecka Scale, Clinical Global Impression-Schizophrenia-Severity (CGI-SCH-S), Clinical Global Impression-Schizophrenia-Improvement (CGI-SCH-I), sleep visual analog scale (VAS), and Personal and Social Performance Scale (PSP). Safety assessments included adverse events (AEs), evaluation of extrapyramidal symptoms (EPS) using the Drug Induced Extrapyramidal Symptoms Scale (DIEPSS), and laboratory tests. RESULTS: Data from a total of 321 subjects who took the paliperidone ER and had at least one follow-up assessment without a major protocol violation were analyzed. Switching to paliperidone ER led to a significant improvement in the Krawiecka, CGI-SCH-S, CGI-SCH-I, PSP, and DIEPSS scales. However, serum prolactin levels and metabolic parameters including body weight and waist circumference were significantly increased. Insomnia was the most common adverse event. CONCLUSION: This study suggested that patients with schizophrenia who showed insufficient response or intolerance to other previous antipsychotics can be switched to paliperidone ER, with efficacy, safety, and tolerability.