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.