A post-authorisation safety survey evaluating risperidone long-acting injectable in Romania

Abstract

Background: The main treatment objectives for schizophrenia, a chronic disease, include clinical response and symptom resolution, relapse prevention, and recovery. Objectives: The primary aim of this prospective survey is to confirm the safety of Risperidone Long-Acting Injectable (RLAI) under marketed conditions. Secondary objectives are to investigate the reasons for the initiation of treatment, effectiveness, and quality of life of patients on RLAI, alongside with compliance, clinical outcome and patients' and clinicians' satisfaction with treatment. Methods: In total, 1354 subjects were recruited by 253 investigational sites in Romania. All patients treated with RLAI, as decided after agreement between the physician and the patient, were eligible for inclusion in this survey. Subjects were either patients requiring a switch from previous antipsychotic medication, or patients at onset of schizophrenia. Data was collected at baseline and at one or more data collection moments. The analysis focussed on the 6 and 12 month timepoints. Results: After intake of RLAI, one third of the patients experienced a treatment-emergent AE. The most common reported AEs were psychiatric disorders related to the underlying disease (insomnia, anxiety, depression and psychotic disorder). Other reported AEs included extrapyramidal symptoms, weight gain, and endocrine disorders (amenorrhea, galactorrhea). The frequencies of these AEs were overall in agreement with those described in the current Summary of Product Characteristics. All parameters assessing drug efficacy showed a statistical significant improvement except for the number and the duration of hospitalizations which increased compared to the 6 months pre-study period. Conclusion: Treatment-emergent AEs observed during this study were consistent with the established safety profile of RLAI. In addition, treatment with RLAI resulted in the expected, statistically relevant improvement of psychiatric status in subjects eligible for such treatment, in most cases subjects diagnosed with schizophrenia and schizoaffective disorders.