PMID- 21755540
OWN - NLM
STAT- MEDLINE
DCOM- 20120628
LR  - 20220330
IS  - 1099-1166 (Electronic)
IS  - 0885-6230 (Linking)
VI  - 27
IP  - 5
DP  - 2012 May
TI  - Short-term safety and pharmacokinetic profile of asenapine in older patients with 
      psychosis.
PG  - 472-82
LID - 10.1002/gps.2737 [doi]
AB  - OBJECTIVES: The aim of this study was to assess the short-term tolerability of 
      two titration schedules of sublingual asenapine in older patients with psychosis, 
      not associated with organic brain disease, and to compare asenapine 
      pharmacokinetics in older patients versus younger adults with schizophrenia. 
      METHODS: Patients >/= 65 years with psychosis without dementia were randomized for 
      6 weeks to two dose-escalation regimens: 2 days at 2 mg twice daily (BID), 2 days 
      at 5 mg BID, and 10 mg BID thereafter (slow escalation); or 4 days at 5 mg BID 
      and 10 mg BID thereafter (rapid escalation). Clinical and pharmacokinetic 
      assessments were performed in each group. RESULTS: Of 122 randomized patients, 76 
      (62.3%) completed the trial. The incidence of treatment-emergent adverse events 
      (AEs) was comparable (72.1%) with both regimens. The most frequently reported AEs 
      were hypertension, headache, and somnolence; incidence of extrapyramidal 
      symptom-related AEs was 5.7%. Mean end point weight change was 0.4 kg. For 
      asenapine 5 and 10 mg BID, median times to maximum concentration were 1.00 and 
      1.06 h, respectively; maximum concentrations (C(max) ) were 4.73 and 7.93 ng/mL; 
      areas under the concentration versus time curve (0-12 h; AUC(0-12) ) were 32.1 
      and 56.3 ng∙h/mL. CONCLUSIONS: Despite 12-30% increases in asenapine C(max) and 
      AUC(0-12) in older patients compared with previously published findings in 
      younger schizophrenia patients, possibly as a result of slower drug clearance, 
      asenapine was generally well tolerated during both dose-escalation schedules. No 
      dose adjustment appears to be necessary in older patients.
CI  - Copyright (c) 2011 John Wiley & Sons, Ltd.
FAU - Dubovsky, Steven L
AU  - Dubovsky SL
AD  - University at Buffalo, Buffalo, NY, USA. dubovsky@buffalo.edu
FAU - Frobose, Colleen
AU  - Frobose C
FAU - Phiri, Phillip
AU  - Phiri P
FAU - de Greef, Rik
AU  - de Greef R
FAU - Panagides, John
AU  - Panagides J
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110713
PL  - England
TA  - Int J Geriatr Psychiatry
JT  - International journal of geriatric psychiatry
JID - 8710629
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Dibenzocycloheptenes)
RN  - 0 (Heterocyclic Compounds, 4 or More Rings)
RN  - JKZ19V908O (asenapine)
SB  - IM
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Antipsychotic Agents/adverse effects/*pharmacokinetics
MH  - Area Under Curve
MH  - Dibenzocycloheptenes
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Heterocyclic Compounds, 4 or More Rings/adverse effects/*pharmacokinetics
MH  - Humans
MH  - Male
MH  - Psychotic Disorders/*drug therapy/metabolism
MH  - Schizophrenia/drug therapy
EDAT- 2011/07/15 06:00
MHDA- 2012/06/29 06:00
CRDT- 2011/07/15 06:00
PHST- 2010/09/16 00:00 [received]
PHST- 2011/03/22 00:00 [accepted]
PHST- 2011/07/15 06:00 [entrez]
PHST- 2011/07/15 06:00 [pubmed]
PHST- 2012/06/29 06:00 [medline]
AID - 10.1002/gps.2737 [doi]
PST - ppublish
SO  - Int J Geriatr Psychiatry. 2012 May;27(5):472-82. doi: 10.1002/gps.2737. Epub 2011 
      Jul 13.