Metabolic syndrome in patients enrolled in a clinical trial of aripiprazole in the maintenance treatment of bipolar I disorder: a post hoc analysis of a randomized, double-blind, placebo-controlled trial.
OBJECTIVE
To compare the effects of maintenance treatment with aripiprazole or placebo on the incidence of metabolic syndrome in bipolar disorder.


METHODS
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 last-observation-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.


BACKGROUND
clinicaltrials.gov Identifier: NCT00036348.
Kemp
David E
DE
Case Western Reserve University School of Medicine, 10524 Euclid Ave, 12th Floor, Cleveland, OH 44106, USA. kemp.david@gmail.com
Calabrese
Joseph R
JR
Tran
Quynh-Van
QV
Pikalov
Andrei
A
Eudicone
James M
JM
Baker
Ross A
RA
D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001118:Argentina; D000068180:Aripiprazole; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000453:epidemiology*; D015897:Comorbidity; D003430:Cross-Sectional Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015994:Incidence; D008134:Long-Term Care; D008297:Male; D024821:Metabolic Syndrome / Q000139:chemically induced* / Q000175:diagnosis / Q000453:epidemiology*; D008875:Middle Aged; D010879:Piperazines / Q000009:adverse effects* / Q000627:therapeutic use; D011569:Psychiatric Status Rating Scales; D015363:Quinolones / Q000009:adverse effects* / Q000627:therapeutic use
D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole