Long acting risperidone in Australian patients with chronic schizophrenia: 24-month data from the e-STAR database

Tim Lambert, Brett Emmerson, Harry Hustig, Sophie Resseler, An Jacobs, Belinda Butcher, e-STAR Research Group, Tim Lambert, Brett Emmerson, Harry Hustig, Sophie Resseler, An Jacobs, Belinda Butcher, e-STAR Research Group

Abstract

Background: This observational study was designed to collect treatment outcomes data in patients using the electronic Schizophrenia Treatment Adherence Registry (e-STAR).

Methods: Patients with schizophrenia or schizoaffective disorder in Australia who were prescribed risperidone long-acting injection (RLAI) between 2003 and 2007 were assessed 12-months retrospectively, at baseline and 24-months prospectively at 3-monthly intervals. The intent-to-treat population, defined as all patients who received at least one dose of RLAI at baseline, was used for the efficacy and safety analyses.

Results: At total of 784 patients (74% with schizophrenia, 69.8% male) with a mean age of 37.1 ± 12.5 years and 10.6 ± 9.5 years since diagnosis were included in this Australian cohort. A significant improvement in mean Clinical Global Impression - severity score was observed at 24-months (4.52 ± 1.04 at baseline, 3.56 ± 1.10 at 24-months). Most of this improvement was seen by 3-months and was also reflected in mean Global Assessment of Functioning score, which improved significantly at 24-months (42.9 ± 14.5 at baseline, 59 ± 15.4 at 24-months). For patients still receiving RLAI at 24-months there was an increase from a mean baseline RLAI dose of 26.4 ± 5 mg to 43.4 ± 15.7 mg. Sixty-six percent of patients discontinued RLAI before the 24-month period--this decreased to 46% once patients lost to follow-up were excluded.

Conclusion: Over the 24-month period, initiation of RLAI was associated with improved patient functioning and illness severity in patients with schizophrenia or schizoaffective disorder. Improved outcomes were observed early and sustained throughout the study.

Trial registration: Clinical Trials Registration Number, NCT00283517.

Figures

Figure 1
Figure 1
Proportion of patients on each dose of RLAI over time (N = 784 at baseline). The proportion of patients on 12.5 mg was 0.5% at 1 month, 0.4% at 2, 6 and 7 months, 0.3% at 3 months, 0.2% at 4, 5 and 8 months. All other time points were 0%. RLAI, risperidone long-acting injection.
Figure 2
Figure 2
CGI-S Score over time - all patients. *Time points were significantly different from baseline (p < 0.001). CGI-S, clinical global impression--severity.
Figure 3
Figure 3
GAF Score over time--all patients. *Time points were significantly different from baseline (p < 0.001). GAF, global assessment of functioning.
Figure 4
Figure 4
Time to discontinuation of RLAI (n = 784).

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