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

Lambert T, Emmerson B, Hustig H, Resseler S, Jacobs A, Butcher B, e-STAR Research Gro - BMC Psychiatry (2012)

Bottom Line: 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).Sixty-six percent of patients discontinued RLAI before the 24-month period--this decreased to 46% once patients lost to follow-up were excluded.Improved outcomes were observed early and sustained throughout the study.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Psychiatry, The University of Melbourne, Melbourne, Australia. tim.lambert@sydney.edu.au

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.

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Time to discontinuation of RLAI (n = 784).
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Figure 4: Time to discontinuation of RLAI (n = 784).

Mentions: The Kaplan-Meier estimate for the percentage of ITT patients who discontinued RLAI before 24-months was 66.7% (95% CI: 63.2% to 70.2%; Figure 4). For the PP population, the Kaplan-Meier estimate was 46.0% (95% CI 41.0% to 51.3%). For the 472 patients in the ITT analysis who discontinued RLAI before 24-months the mean time to discontinuation was 239 ± 180 days. The main reasons cited for discontinuation were insufficient response to treatment (25.8%) and lost to follow-up (23.7%). Excluding patients with lost to follow-up given as the reason for RLAI discontinuation (i.e. patients with no 24-month follow-up); the rate decreases to 46%. The most frequently prescribed antipsychotic at the time of discontinuation of RLAI was oral risperidone (21.6%) either alone (15.3%) or in combination with other antipsychotics (6.3%). Other agents frequently prescribed (either alone or in combination) were olanzapine (9.5%), clozapine (9.1%) and zuclopenthixol (8.1%).


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

Lambert T, Emmerson B, Hustig H, Resseler S, Jacobs A, Butcher B, e-STAR Research Gro - BMC Psychiatry (2012)

Time to discontinuation of RLAI (n = 784).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3361492&req=5

Figure 4: Time to discontinuation of RLAI (n = 784).
Mentions: The Kaplan-Meier estimate for the percentage of ITT patients who discontinued RLAI before 24-months was 66.7% (95% CI: 63.2% to 70.2%; Figure 4). For the PP population, the Kaplan-Meier estimate was 46.0% (95% CI 41.0% to 51.3%). For the 472 patients in the ITT analysis who discontinued RLAI before 24-months the mean time to discontinuation was 239 ± 180 days. The main reasons cited for discontinuation were insufficient response to treatment (25.8%) and lost to follow-up (23.7%). Excluding patients with lost to follow-up given as the reason for RLAI discontinuation (i.e. patients with no 24-month follow-up); the rate decreases to 46%. The most frequently prescribed antipsychotic at the time of discontinuation of RLAI was oral risperidone (21.6%) either alone (15.3%) or in combination with other antipsychotics (6.3%). Other agents frequently prescribed (either alone or in combination) were olanzapine (9.5%), clozapine (9.1%) and zuclopenthixol (8.1%).

Bottom Line: 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).Sixty-six percent of patients discontinued RLAI before the 24-month period--this decreased to 46% once patients lost to follow-up were excluded.Improved outcomes were observed early and sustained throughout the study.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Psychiatry, The University of Melbourne, Melbourne, Australia. tim.lambert@sydney.edu.au

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.

Show MeSH
Related in: MedlinePlus