PMID- 21538537 OWN - NLM STAT- MEDLINE DCOM- 20120320 LR - 20151119 IS - 1099-1166 (Electronic) IS - 0885-6230 (Linking) VI - 27 IP - 3 DP - 2012 Mar TI - Tolerability of extended-release quetiapine fumarate compared with immediate-release quetiapine fumarate in older patients with Alzheimer's disease with symptoms of psychosis and/or agitation: a randomised, double-blind, parallel-group study. PG - 296-304 LID - 10.1002/gps.2720 [doi] AB - OBJECTIVE: The objective of this study was to assess the safety and tolerability of extended-release quetiapine fumarate (quetiapine XR) compared with quetiapine immediate-release (quetiapine IR) in older patients with Alzheimer's disease with symptoms of psychosis and/or agitation. METHODS: This was a 6-week, double-blind, double-dummy, randomised study. Of the 109 patients screened, 100 were randomised to receive quetiapine XR (n = 68) or quetiapine IR (n = 32), at doses of 50 and 25 mg/day, respectively. Treatment was escalated to 100 mg/day by Day 4. At Day 8, a flexible-dose (50-300 mg/day) period began when dose adjustment was made at the investigator's discretion. The primary variable was incidence and type of adverse events (AEs). Secondary variables included efficacy and other safety assessments. RESULTS: Mean daily doses were 143.6 and 142.0 mg in the quetiapine XR and quetiapine IR groups, respectively. Ninety patients completed the study; only one withdrew (in the quetiapine XR group) because of an AE. Laboratory evaluations identified severe neutropaenia (one patient), mild neutropaenia (three patients) and eosinophilia (five patients); however, these were not reported, as AEs and confounding factors, such as patient age, concomitant illness and medication, made it difficult to determine any relationship to quetiapine treatment. Numerical improvements from baseline were seen across both treatment groups in Neuropsychiatric Inventory frequency x severity total, Neuropsychiatric Inventory-Nursing Home version, Cohen-Mansfield Agitation Inventory, Clinical Global Impression-Severity of Illness and Clinical Global Impression-Improvement scores. CONCLUSION: Quetiapine XR dosed up to 300 mg/day was generally well tolerated, with a similar profile to that of quetiapine IR. CI - Copyright (c) 2011 John Wiley & Sons, Ltd. FAU - De Deyn, Peter Paul AU - De Deyn PP AD - Department of Neurology, Middelheim Hospital and Laboratory of Neurochemistry and Behaviour, Department of Biomedical Sciences, Institute Born Bunge, University of Antwerp, Antwerp, Belgium. dedeyn@skynet.be FAU - Eriksson, Hans AU - Eriksson H FAU - Svensson, Hanna AU - Svensson H CN - Study 115 investigators LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20110427 PL - England TA - Int J Geriatr Psychiatry JT - International journal of geriatric psychiatry JID - 8710629 RN - 0 (Antipsychotic Agents) RN - 0 (Delayed-Action Preparations) RN - 0 (Dibenzothiazepines) RN - 2S3PL1B6UJ (Quetiapine Fumarate) SB - IM MH - Aged MH - Aged, 80 and over MH - Alzheimer Disease/complications/*drug therapy MH - Antipsychotic Agents/*administration & dosage/adverse effects MH - Delayed-Action Preparations/administration & dosage/adverse effects MH - Dibenzothiazepines/*administration & dosage/adverse effects MH - Double-Blind Method MH - Drug Administration Schedule MH - Female MH - Humans MH - Male MH - Psychomotor Agitation/*drug therapy/etiology MH - Psychotic Disorders/*drug therapy/etiology MH - Quetiapine Fumarate FIR - Brodaty, Henry IR - Brodaty H FIR - Ames, David IR - Ames D FIR - Hustig, Harry IR - Hustig H FIR - Steinburg, Jon IR - Steinburg J FIR - D'Souza, Russell IR - D'Souza R FIR - De Deyn, Peter Paul IR - De Deyn PP FIR - Bouckaert, Filip IR - Bouckaert F FIR - Roger, Pascale IR - Roger P FIR - Rabheru, Kian IR - Rabheru K FIR - Nashed, Yousery IR - Nashed Y FIR - Van Reekum, Robert IR - Van Reekum R FIR - Moksnnes, Kjell Martin IR - Moksnnes KM FIR - Lindvig, Torgeir IR - Lindvig T FIR - Lorentzen, Bernhard IR - Lorentzen B FIR - Selemani, S IR - Selemani S FIR - Potoctik, Felix IR - Potoctik F FIR - Mkize, Dan L IR - Mkize DL FIR - Gagiano, Carllo Andrias IR - Gagiano CA EDAT- 2011/05/04 06:00 MHDA- 2012/03/21 06:00 CRDT- 2011/05/04 06:00 PHST- 2010/10/06 00:00 [received] PHST- 2011/02/09 00:00 [revised] PHST- 2011/02/28 00:00 [accepted] PHST- 2011/05/04 06:00 [entrez] PHST- 2011/05/04 06:00 [pubmed] PHST- 2012/03/21 06:00 [medline] AID - 10.1002/gps.2720 [doi] PST - ppublish SO - Int J Geriatr Psychiatry. 2012 Mar;27(3):296-304. doi: 10.1002/gps.2720. Epub 2011 Apr 27.