Safety, tolerability and treatment response with flexible doses of paliperidone palmitate in patients with an acute exacerbation of schizophrenia

Objective: To explore tolerability, safety and treatment response with flexible doses of paliperidone palmitate in adult patients with an acute episode of schizophrenia. Methods: Interim analysis of a prospective 6-month, open-label, multicenter study in adult patients with schizophrenia. Outcomes were change PANSS, CGI-S, PSP weight change and adverse events (AEs). Results: Of the first 104 patients included (54.8% male, mean age 37.6 ± 11.8 years, 65.4% completed the study. Most frequent reasons for discontinuation were AE (13.5%), subject choice (8.7%) and loss to follow-up (5.8%). Mean total PANSS score decreased from 99.5 ± 15.5 to 71.0 ± 26.9 (mean change -28.6 ± 26.2; 95% confidence interval [CI] -33.8; -23.4; p < 0.0001) with 60.6% of the patients showing an improvement of ≥30%. Mean CGI-S score changed from 5.0 ± 0.8 at baseline to 3.6 ± 1.3 at endpoint (95% CI -1.7; -1.1; p < 0.0001). Patient functioning improved from a mean PSP baseline score of 42.7 ± 13.9 to 59.0 ± 18.7 at endpoint (95% CI of change 12.7; 19.9; p < 0.0001). AEs reported in ≥5% were psychotic disorder (15.4%), insomnia (14.4%), injection site pain (13.5%), headache (8.7%), salivary hypersecretion (6.7%) and anxiety (6.7%). Conclusion: These data support results from recent randomized controlled studies that flexibly dosed paliperidone palmitate is safe, well tolerated and associated with a clinically meaningful treatment response in patients suffering from an acute episode of schizophrenia. This study was supported by This study was supported by funding vom Janssen-Cilag International NV.