Objective: To document prescribing patterns in clinical practice and assess long-term outcomes related to initiation of paliperidone ER and other oral antipsychotics among patients with schizophrenia in a naturalistic setting.
Research design and methods: An international, non-interventional, naturalistic study of adult patients (≥18 years) with schizophrenia. Patients were assigned to the relevant treatment group (paliperidone ER or 'all other oral antipsychotics') after switching to, or initiating, oral antipsychotic treatment. Retrospective 12 month data collection was followed by 12 month prospective data collection, with 3-monthly assessments. The primary endpoint was time to all-cause discontinuation of new medication. Secondary endpoints included Clinical Global Impression-Severity (CGI-S) score, Clinical Global Impression-Schizophrenia (CGI-SCH) score, Personal and Social Performance (PSP) score, health-related quality of life (HR-QoL) and quality of sleep, evaluation of healthcare resource utilization and patient's treatment satisfaction.
Results: A total of 4051 patients were included in the intent-to-treat (ITT) analysis set. All-cause study discontinuation rates were comparable between the paliperidone ER group (16.8%) and the 'all other oral antipsychotics' group (15.5%). There was no difference in the time to discontinuation of newly initiated antipsychotic treatments between paliperidone ER and 'all other oral antipsychotics' groups. Paliperidone ER was associated with greater improvements from baseline to endpoint in both the PSP scale score (+14.2 vs +13.1, p = 0.041) and the physical component of quality of life (SF-12 Physical scores; +3.9 vs +2.9, p = 0.003) compared to 'all other oral antipsychotics'. Improvements in mean CGI-S score, CGI-SCH score, HR-QoL, quality of sleep and daytime drowsiness, as well as patients' treatment satisfaction were comparable between treatment groups. The incidence of adverse events was comparable between groups.
Conclusions: This study provides valuable data on the prescribing habits and treatment outcomes associated with use of paliperidone ER in everyday clinical practice, and supports previous findings of the favorable functional improvement and treatment satisfaction associated with paliperidone ER.
Clinical trial registration: NCT00696813; R076477SCH4015 (Register of German Association of Research-based Pharmaceutical Companies [VFA] http://www.vfa.de/de/arzneimittel-forschung/datenbanken-zu-arzneimitteln/nisdb).
Keywords: Effectiveness; Oral antipsychotics; Paliperidone ER; Schizophrenia.