Real-world paliperidone palmitate data from acute units: The SHADOW study

Abstract

Introduction

There is an increasing interest in understanding how antipsychotic treatments work in a real-world-setting. This is especially important with long-acting-antipsychotics, where explanatory trials may not always represent the real-world-population. Observational studies and pragmatic-clinical trials could provide additional information about new therapies, which could inform decision-making processes.

Objectives

To assess the effectiveness of Paliperidone-Palmitate(PP) in an acute setting within real-world-conditions. Functionality, satisfaction with treatment and pattern of use were also evaluated.

Methods

An observational, prospective 6-week follow-up study was performed in acute units including adult patients with acute exacerbation of schizophrenia that started treatment with PP. Data were collected from initiation of PP until week-6 (or patient's discharge if earlier). Clinical-Global Inventory-Severity (CGI-S) was used to assess effectiveness as well as changes in illness severity. Other outcomes included total score on the Personal and Social Performance scale (PSP), patient-satisfaction with medication (MSQ) and tolerability. Student's-t tests were used to assess changes from baseline in CGI-S and PSP.

Results

Two hundred and eighty patients were included in the analysis (mean age: 40.5 ± 12.2 [SD] years). A significant decrease in mean (SD) CGI-S score between baseline (4.7 [0.9]) and endpoint (3.3 [0.9]) (P < 0.0001) was observed. (Note that 21% of patients were discharged on PP-monotherapy). Patient-functioning also significantly improved from baseline to endpoint (P < 0.0001). Seventy-four percent of patients were satisfied (measured by MSQ) at the end of follow-up. Anticholinergic-treatment was less frequent for PP discharged on monotherapy vs. not monotherapy (12.5% vs 21.2% respectively). Overall, PP was well-tolerated. Twenty-five AEs were reported in 20 patients (incidence 7.1%). No serious AEs occurred.

Conclusions

These results support the effectiveness and tolerability of PP in an acute setting under daily-clinical-practice with good acceptance by patients.

Disclosure of interest

The authors have not supplied their declaration of competing interest.