期刊
JOURNAL OF CLINICAL PSYCHIATRY
卷 71, 期 9, 页码 1138-1144出版社
PHYSICIANS POSTGRADUATE PRESS
DOI: 10.4088/JCP.09m05159gre
关键词
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资金
- National Alliance for Research on Schizophrenia and Depression (NARSAD)
- International Society for Bipolar Disorders
- Department of Defense, Health Resources Services Administration
- National Institute of Mental Health
- Cleveland Foundation
- Repligen
- Stanley Medical Research Institute
- Abbott
- AstraZeneca
- Bristol-Myers Squibb
- Cephalon
- Eli Lilly
- GlaxoSmithKline
- Janssen
- Takeda
- Wyeth
- National Center for Research Resources (NCRR) [KL2 RR024990]
- NIH Roadmap for Medical Research
- Bristol-Myers Squibb (Princeton, New Jersey)
- Otsuka Pharmaceutical Co, Ltd. (Tokyo, Japan)
Objective: To compare the effects of maintenance treatment with aripiprazole or placebo on the incidence of metabolic syndrome in bipolar disorder. Method: Patients with DSM-IV bipolar I disorder were stabilized on aripiprazole therapy for 6-18 weeks prior to double-blind random assignment to aripiprazole or placebo for 26 weeks. The rate of metabolic syndrome in each group was calculated at maintenance phase baseline (randomization) and endpoint for evaluable patients using a lastobservation-carried-forward (LOCF) approach. Metabolic syndrome was defined using the National Cholesterol Education Program Adult Treatment Panel III criteria. The study was conducted from March 2000 to June 2003 at 76 centers in Argentina, Mexico, and the United States. Results: At entry into the maintenance phase, 45/125 patients (36.0%) overall met criteria for metabolic syndrome. Mean changes in the 5 components of metabolic syndrome (waist circumference, triglyceride levels, high-density lipoprotein cholesterol level, blood pressure, and glucose level) from baseline to week 26 were small except for a meaningful reduction in triglycerides (placebo -18.9 mg/dL; aripiprazole -11.5 mg/dL). By the end of the maintenance phase (endpoint, LOCF), 5/18 placebo-treated patients (27.8%) and 4/14 aripiprazole-treated patients (28.6%) no longer met metabolic syndrome criteria. The proportion of patients with metabolic syndrome was similar in the placebo and aripiprazole groups at both baseline and week 26. There were no significant changes in any of the individual components of metabolic syndrome between aripiprazole- and placebo-treated patients during maintenance phase treatment. Conclusions: The prevalence of metabolic syndrome in patients with bipolar disorder is higher than that commonly reported in the general population. The effect of 26 weeks of treatment with aripiprazole on the incidence of metabolic syndrome and its components was similar to placebo. Trial Registration: clinicaltrials.gov Identifier: NCT00036348 J Clin Psychiatry 2010;71(9):1138-1144 (C) Copyright 2010 Physicians Postgraduate Press, Inc.
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