PMID- 20196185 OWN - NLM STAT- MEDLINE DCOM- 20100614 LR - 20220318 IS - 1099-1077 (Electronic) IS - 0885-6222 (Linking) VI - 25 IP - 2 DP - 2010 Mar TI - Safety and tolerability of once-daily extended release quetiapine fumarate in acute schizophrenia: pooled data from randomised, double-blind, placebo-controlled studies. PG - 103-15 LID - 10.1002/hup.1091 [doi] AB - INTRODUCTION: 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. CI - Copyright 2010 John Wiley & Sons, Ltd. FAU - Meulien, Didier AU - Meulien D AD - AstraZeneca Research & Development, Sodertalje, Sweden. FAU - Huizar, Karin AU - Huizar K FAU - Brecher, Martin AU - Brecher M LA - eng PT - Journal Article PT - Meta-Analysis PL - England TA - Hum Psychopharmacol JT - Human psychopharmacology JID - 8702539 RN - 0 (Antipsychotic Agents) RN - 0 (Delayed-Action Preparations) RN - 0 (Dibenzothiazepines) RN - 2S3PL1B6UJ (Quetiapine Fumarate) SB - IM MH - Acute Disease MH - Adolescent MH - Adult MH - Aged MH - Antipsychotic Agents/administration & dosage/*adverse effects/therapeutic use MH - Clinical Trials, Phase III as Topic MH - Delayed-Action Preparations/administration & dosage/adverse effects/therapeutic use MH - Diagnostic and Statistical Manual of Mental Disorders MH - Dibenzothiazepines/administration & dosage/*adverse effects/therapeutic use MH - Double-Blind Method MH - Female MH - Humans MH - Male MH - Middle Aged MH - Multicenter Studies as Topic MH - Neutropenia/chemically induced MH - Quetiapine Fumarate MH - Randomized Controlled Trials as Topic MH - Schizophrenia/*drug therapy MH - Young Adult EDAT- 2010/03/03 06:00 MHDA- 2010/06/15 06:00 CRDT- 2010/03/03 06:00 PHST- 2010/03/03 06:00 [entrez] PHST- 2010/03/03 06:00 [pubmed] PHST- 2010/06/15 06:00 [medline] AID - 10.1002/hup.1091 [doi] PST - ppublish SO - Hum Psychopharmacol. 2010 Mar;25(2):103-15. doi: 10.1002/hup.1091.