Paliperidone Palmitate Treatment in Outpatient Care Setting: A Naturalistic Study.

OBJECTIVES: To evaluate paliperidone palmitate (PP) effectiveness, safety and adherence to treatment.

METHODS: We collected data of all patients (n = 50) affected by Schizophrenia Disorders, treated with PP for a 3 month minimum period in the outpatient setting of Mental Health Department in Modena, from 01/01/2014 to 31/01/2015. We evaluated reasons and modality for PP implementation, improvement in symptom and functioning scales, adverse effects, discontinuations and relapses. We statistically correlated socio-demographic and clinical variables of our sample with PP therapeutic variables.

RESULTS: We registered an improvement in all scales, with a superior percentage in PANSS positive subscale. The mean PP dose in some patients was lower than official indications, although our sample was clinically severe. Illness relapses affected 60% and dropout 18% of patients. PP was well tolerated and in just a few cases adverse events required treatment interruption. The risk factors for discontinuation were represented by "lack of therapeutic compliance" (HR = 4.11, p < 0.0001) and "inefficacy" (HR = 1.67, p < 0.0001).

CONCLUSIONS: With limitations of observational design, this research highlights that PP was well tolerated and effective in improving both psychotic symptoms and functioning, but moderately effective in preventing relapse, probably due to clinical severity of our patients associated with extremely cautious and flexible PP prescriptions.