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Efficacy and tolerability of quetiapine XR 400/600/800mg/day in acute schizophrenia: a post-hoc analysis of data from two pooled randomised studies

Published online by Cambridge University Press:  16 April 2020

R. Kahn
Affiliation:
Department of Psychiatry, Rudolf Magnus Institute of Neuroscience, Utrecht, The Netherlands
A. Kalali
Affiliation:
Quintiles Inc., San Diego and University of California, San Diego, CA, USA
U. Gustafsson
Affiliation:
Astrazeneca, Södertälje, Sweden
S. Nyberg
Affiliation:
Astrazeneca, Södertälje, Sweden

Abstract

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Introduction

Data from two, identically designed, placebo-controlled, randomised, double-blind clinical trials (D1444C00132+D1444C00133) for once-daily extended-release quetiapine fumarate (QTP-XR) were pooled and analysed.

Objective

Evaluate dose response, efficacy and safety for QTP-XR in schizophrenia.

Methods

Post-hoc analysis of data from patients receiving QTP-XR 400, 600, 800 mg/day or placebo. Endpoints: least squares means (LSM) change from baseline to Day 42 in PANSS total and positive and negative subscale scores. No corrections for multiplicity were performed. Adverse events (AEs) were recorded.

Results

914 patients were included; PANSS scores were assessed in the MITT population (n = 889). LSM change from baseline in PANSS total score diverged significantly from placebo at: Day 14 for QTP-XR 800 mg/day (-15.3 vs -12.1 for placebo; p = 0.018); Day 21 for 600 mg/day (-17.3 vs -14.2; p = 0.039); Day 42 for 400 mg/day (-19.2 vs -15.4; p = 0.033).

Jonckheere-Terpstra analysis of change in PANSS total score at Day 42 showed a significant QTP-XR dose response (p = 0.0196; p < 0.001 with placebo). PANSS positive scores diverged by Day 21 for both QTP-XR 800 (-5.7 vs -4.8; p = 0.049) and 600 mg/day (-5.8 vs -4.8; p = 0.046). PANSS negative scores diverged by Day 21 (-4.0 vs -3.2; p = 0.040) and 42 (-4.8 vs -3.6; p = 0.009) for QTP-XR 800 and 600 mg/day, respectively. AEs occurred in 59.4%, 66.5%, 62.1% and 56.2% of patients in the QTP-XR 800, 600, 400 mg/day and placebo groups, respectively. Most common AEs were somnolence, dry mouth, sedation, insomnia, dizziness, headache, constipation and nausea.

Conclusions

QTP-XR was generally well tolerated and demonstrated efficacy that increased with dose in schizophrenia.

Financial support: AstraZeneca.

Type
P03-242
Copyright
Copyright © European Psychiatric Association 2011
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