Skip to main content Accessibility help
×
Home
Hostname: page-component-78dcdb465f-hcvhd Total loading time: 0.325 Render date: 2021-04-20T01:49:20.569Z Has data issue: true Feature Flags: { "shouldUseShareProductTool": true, "shouldUseHypothesis": true, "isUnsiloEnabled": true, "metricsAbstractViews": false, "figures": false, "newCiteModal": false, "newCitedByModal": true }

Article contents

P0174 - Once-daily extended release quetiapine fumarate (quetiapine xr): Pooled safety data from 3 placebo-controlled monotherapy studies in acute schizophrenia

Published online by Cambridge University Press:  16 April 2020

D. Meulien
Affiliation:
AstraZeneca R&D, Sodertalje, Sweden
M. Brecher
Affiliation:
AstraZeneca Pharmaceuticals, Wilmington, DE, USA
K. Huizar
Affiliation:
AstraZeneca R&D, Sodertalje, Sweden
Get access

Abstract

Objective:

To assess the safety and tolerability of quetiapine XR using pooled data from 3 studies (5077IL/0041, D1444C00132, D1444C00133).

Methods:

Quetiapine XR (300mg [1 study], 400mg [2 studies], 600mg or 800mg once daily) was evaluated in 3 similarly designed, 6-week, placebo-controlled, double-blind, randomised studies in patients with acute schizophrenia. Matched dose quetiapine IR was included to demonstrate assay sensitivity. Safety assessments included AEs and vital signs.

Results:

The pooled safety population included 1684 patients (951, quetiapine XR; 414, quetiapine IR; 319, placebo). Mean (SD) duration of exposure to quetiapine XR, quetiapine IR and placebo was 31.8 (14.9), 29.4 (15.9) and 30.6 (15.6) days, respectively.

The percentage of patients reporting an AE was similar for quetiapine XR (69.5%), quetiapine IR (72.5%) and placebo (61.4%). Serious AE incidence was similar for quetiapine XR (4.4%), quetiapine IR (3.9%) and placebo (4.4%). 6.4%, 7.7% and 7.5% of patients receiving quetiapine XR, quetiapine IR and placebo discontinued owing to AEs, respectively.

The five most common drug-related AEs (≥5%) were: sedation (11.5%, 14.0%, 5.0%), somnolence (10.6%, 11.4%, 3.1%), dry mouth (10.4%, 8.0%, 1.3%), dizziness (7.5%, 6.8%, 3.1%) and orthostatic hypertension (5.8%, 7.5%, 3.8%), for quetiapine XR, quetiapine IR and placebo, respectively. There was no dose relationship with any common AE for quetiapine XR. For completers, mean weight increases were: quetiapine XR (n=555), 1.77kg; quetiapine IR (n=215), 2.19kg; placebo (n=163), 0.26kg.

Conclusions:

Once-daily quetiapine XR (300-800mg/day) was well tolerated in patients with acute schizophrenia. The tolerability profile was consistent with the known safety profile for quetiapine IR.

Type
Poster Session I: Schizophrenia and Psychosis
Copyright
Copyright © European Psychiatric Association 2008

Access options

Get access to the full version of this content by using one of the access options below.
Submit a response

Comments

No Comments have been published for this article.

Full text views

Full text views reflects PDF downloads, PDFs sent to Google Drive, Dropbox and Kindle and HTML full text views.

Total number of HTML views: 0
Total number of PDF views: 3 *
View data table for this chart

* Views captured on Cambridge Core between 16th April 2020 - 20th April 2021. This data will be updated every 24 hours.

Send article to Kindle

To send this article to your Kindle, first ensure no-reply@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about sending to your Kindle. Find out more about sending to your Kindle.

Note you can select to send to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be sent to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

Find out more about the Kindle Personal Document Service.

P0174 - Once-daily extended release quetiapine fumarate (quetiapine xr): Pooled safety data from 3 placebo-controlled monotherapy studies in acute schizophrenia
Available formats
×

Send article to Dropbox

To send this article to your Dropbox account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Dropbox.

P0174 - Once-daily extended release quetiapine fumarate (quetiapine xr): Pooled safety data from 3 placebo-controlled monotherapy studies in acute schizophrenia
Available formats
×

Send article to Google Drive

To send this article to your Google Drive account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Google Drive.

P0174 - Once-daily extended release quetiapine fumarate (quetiapine xr): Pooled safety data from 3 placebo-controlled monotherapy studies in acute schizophrenia
Available formats
×
×

Reply to: Submit a response


Your details


Conflicting interests

Do you have any conflicting interests? *