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Safety and tolerability of once‐daily extended release quetiapine fumarate in acute schizophrenia: pooled data from randomised, double‐blind, placebo‐controlled studies
Author(s) -
Meulien Didier,
Huizar Karin,
Brecher Martin
Publication year - 2010
Publication title -
human psychopharmacology: clinical and experimental
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.461
H-Index - 78
eISSN - 1099-1077
pISSN - 0885-6222
DOI - 10.1002/hup.1091
Subject(s) - tolerability , quetiapine , placebo , quetiapine fumarate , double blind , medicine , schizophrenia (object oriented programming) , adverse effect , pharmacology , psychiatry , psychology , atypical antipsychotic , antipsychotic , alternative medicine , pathology
Extended release quetiapine fumarate (quetiapine XR) is a new formulation that allows once‐daily dosing and a titration regimen that is simpler than that of immediate release quetiapine (quetiapine IR) and may potentially increase patients' adherence to their prescribed medication. Methods The tolerability of quetiapine XR was examined in an analysis of pooled data from three Phase III, double‐blind, placebo‐controlled, randomised studies with quetiapine IR as a reference treatment. Results The overall incidence of adverse events (AEs) was similar for quetiapine XR (69.5%) and quetiapine IR (72.5%). Most AEs were mild to moderate in severity and in line with those observed with quetiapine IR. The more rapid dose titration of quetiapine XR did not produce any new safety concerns and was as well tolerated as the regimen for quetiapine IR. Conclusions The results of this pooled analysis show that quetiapine XR administered once daily is generally as well tolerated as quetiapine IR given twice daily. These data, together with the simpler dose‐titration of quetiapine XR that allowed therapeutically effective doses to be reached by Day 2, suggest that this formulation potentially may improve adherence in patients with schizophrenia. Copyright © 2010 John Wiley & Sons, Ltd.