Document Detail


Comparison of longer-term safety and effectiveness of 4 atypical antipsychotics in patients over age 40: a trial using equipoise-stratified randomization.
MedLine Citation:
PMID:  23218100     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To compare longer-term safety and effectiveness of the 4 most commonly used atypical antipsychotics (aripiprazole, olanzapine, quetiapine, and risperidone) in 332 patients, aged > 40 years, having psychosis associated with schizophrenia, mood disorders, posttraumatic stress disorder, or dementia, diagnosed using DSM-IV-TR criteria.
METHOD: We used equipoise-stratified randomization (a hybrid of complete randomization and clinician's choice methods) that allowed patients or their treating psychiatrists to exclude 1 or 2 of the study atypical antipsychotics due to past experience or anticipated risk. Patients were followed for up to 2 years, with assessments at baseline, 6 weeks, 12 weeks, and every 12 weeks thereafter. Medications were administered employing open-label design and flexible dosages, but with blind raters. The study was conducted from October 2005 to October 2010.
OUTCOME MEASURES: Primary metabolic markers (body mass index, blood pressure, fasting blood glucose, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides), percentage of patients who stay on the randomly assigned atypical antipsychotic for at least 6 months, psychopathology, percentage of patients who develop metabolic syndrome, and percentage of patients who develop serious and nonserious adverse events.
RESULTS: Because of a high incidence of serious adverse events, quetiapine was discontinued midway through the trial. There were significant differences among patients willing to be randomized to different atypical antipsychotics (P < .01), suggesting that treating clinicians tended to exclude olanzapine and prefer aripiprazole as one of the possible choices in patients with metabolic problems. Yet, the atypical antipsychotic groups did not differ in longitudinal changes in metabolic parameters or on most other outcome measures. Overall results suggested a high discontinuation rate (median duration 26 weeks prior to discontinuation), lack of significant improvement in psychopathology, and high cumulative incidence of metabolic syndrome (36.5% in 1 year) and of serious (23.7%) and nonserious (50.8%) adverse events for all atypical antipsychotics in the study.
CONCLUSIONS: Employing a study design that closely mimicked clinical practice, we found a lack of effectiveness and a high incidence of side effects with 4 commonly prescribed atypical antipsychotics across diagnostic groups in patients over age 40, with relatively few differences among the drugs. Caution in the use of these drugs is warranted in middle-aged and older patients.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00245206.
Authors:
Hua Jin; Pei-an Betty Shih; Shahrokh Golshan; Sunder Mudaliar; Robert Henry; Danielle K Glorioso; Stephan Arndt; Helena C Kraemer; Dilip V Jeste
Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2012-11-27
Journal Detail:
Title:  The Journal of clinical psychiatry     Volume:  74     ISSN:  1555-2101     ISO Abbreviation:  J Clin Psychiatry     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-02-19     Completed Date:  2013-04-15     Revised Date:  2014-03-19    
Medline Journal Info:
Nlm Unique ID:  7801243     Medline TA:  J Clin Psychiatry     Country:  United States    
Other Details:
Languages:  eng     Pagination:  10-8     Citation Subset:  IM    
Copyright Information:
© Copyright 2013 Physicians Postgraduate Press, Inc.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00245206
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Adult
Age Factors
Aged
Aged, 80 and over
Antipsychotic Agents / adverse effects,  therapeutic use*
Benzodiazepines / adverse effects,  therapeutic use*
Biological Markers / blood
Blood Glucose / metabolism
Blood Pressure / drug effects
Body Mass Index
Cholesterol / blood
Dibenzothiazepines / adverse effects,  therapeutic use*
Female
Follow-Up Studies
Humans
Male
Metabolic Syndrome X / blood,  chemically induced
Middle Aged
Piperazines / adverse effects*,  therapeutic use*
Psychiatric Status Rating Scales
Psychotic Disorders / drug therapy*
Quinolones / adverse effects,  therapeutic use*
Risperidone / adverse effects*,  therapeutic use
Schizophrenia / drug therapy*
Therapeutic Equipoise
Triglycerides / blood
United States
Grant Support
ID/Acronym/Agency:
1K01DK087813-01/DK/NIDDK NIH HHS; K01 DK087813/DK/NIDDK NIH HHS; M01RR 000827/RR/NCRR NIH HHS; MH071536/MH/NIMH NIH HHS; P30 MH080002/MH/NIMH NIH HHS; P30MH080002-01/MH/NIMH NIH HHS; R01 MH071536/MH/NIMH NIH HHS; TL1 RR031979/RR/NCRR NIH HHS; UL1RR031980/RR/NCRR NIH HHS
Chemical
Reg. No./Substance:
0/Antipsychotic Agents; 0/Biological Markers; 0/Blood Glucose; 0/Dibenzothiazepines; 0/Piperazines; 0/Quinolones; 0/Triglycerides; 12794-10-4/Benzodiazepines; 132539-06-1/olanzapine; 82VFR53I78/aripiprazole; 97C5T2UQ7J/Cholesterol; BGL0JSY5SI/quetiapine; L6UH7ZF8HC/Risperidone
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  Living Through Distress: A Skills Training Group for Reducing Deliberate Self-Harm.
Next Document:  Multidisciplinary clinic care improves adherence to best practice in head and neck cancer.