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Clinical benefit of switching patients with schizophrenia to once-daily quetiapine sustained release

Published online by Cambridge University Press:  16 April 2020

S. Ganesan
Affiliation:
Department of Psychiatry, University of Vancouver, BC, Canada
V. Agambaram
Affiliation:
Central Medical Suites, Entabeni Hospital, Durban, South Africa
F. Randeree
Affiliation:
Department of Psychiatry, Nelson Mandela School of Medicine, University of Kwazulu-Natal, Durban, South Africa
I. Eggens
Affiliation:
AstraZeneca R&D, Södertälje, Sweden
M.M. Schmidt
Affiliation:
AstraZeneca R&D, Södertälje, Sweden
D. Meulien
Affiliation:
AstraZeneca R&D, Södertälje, Sweden

Abstract

Aim:

To evaluate the clinical benefit of switching to quetiapine sustained release (SR) in patients with schizophrenia experiencing suboptimal efficacy/tolerability with their current antipsychotic.

Methods:

This was a 12-week, multicentre, open-label study (D1444C00147). Quetiapine SR (mg/day) was initiated during a 4-day cross titration phase (300 on Day 1; 600 on Day 2; 400, 600 or 800 on Day 3; flexible-dosing [400-800] from Days 4-84). Primary objective was to demonstrate that >50% of patients would achieve clinical benefit (improved CGI-Clinical Benefit [CB] score, based on CGI-I Efficacy index and tolerability burden) at Week 12. Secondary endpoints included CGI-I and PANSS total scores. Tolerability was assessed by adverse events (AEs), SAS and BARS scores. Mean changes in rating scale scores were analysed using ANCOVA.

Results:

477 patients were switched to quetiapine SR, 370 (77.6%) completed treatment. 295 of 470 evaluable patients (62.8%) achieved a clinical benefit upon switching to quetiapine SR (95% CI 58.4, 67.1, p<0.0001). Significant improvements were observed in mean [SD] change from baseline in CGI-CB (-2.1 [3.62]) and PANSS total (-13.6 [19.23]) (both p<0.001). Mean [SD] CGI-I score at endpoint was 2.8 [1.49] (p<0.001 for mean CGI-I<4). Common AEs included somnolence (17.8%), sedation (15.1%), dizziness and dry mouth (14.0% each). The incidence of EPS was 8.0%. Mean changes (improvements) from baseline in SAS and BARS scores were -2.1 and -0.4 respectively (both p<0.001).

Conclusion:

Switching to quetiapine SR was associated with clinical benefit and was well tolerated in patients with schizophrenia experiencing suboptimal efficacy/tolerability with their previous antipsychotic treatment.

Type
Poster Session 2: Child Psychiatry
Copyright
Copyright © European Psychiatric Association 2007
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