Cardiometabolic Adverse Effects and Its Predictors in Children and Adolescents With First-Episode Psychosis During Treatment With Quetiapine-Extended Release Versus Aripiprazole: 12-Week Results From the Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis (TEA) Trial
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OBJECTIVE: To investigate cardiometabolic effects and its predictors in youth with first-episode psychosis (FEP) treated with quetiapine-extended release (ER) vs. aripiprazole.
METHOD: Youths with FEP aged 12-17 years were randomized to quetiapine-ER or aripiprazole in the 12-week, double-blinded, Tolerability and Efficacy of Antipsychotics (TEA) trial. Primary outcome was change in body weight; secondary outcomes were changes in body mass index (BMI) and waist circumference (WC), blood pressure (BP), heart rate, and lipid and glucose metabolism parameters. Possible predictors of cardiometabolic changes were examined.
RESULTS: Altogether, 113 patients (schizophrenia-spectrum disorders=93%, age (mean±SD): 15.7±1.4 years, male participants=30.1%), were randomized to quetiapine-ER (n=55) or aripiprazole (n=58). Quetiapine-ER led to significant increases in body weight (4.88 kg, 95% confidence interval (CI): 3.92-5.83, p<.0001), BMI z-score (0.43, 95%CI= 0.33-0.53, p<0.0001) and WC z-score (0.97, CI=0.7-1.23, p<0.0001). Changes were significantly smaller with aripiprazole (all between-group p-values p<0.0001): body weight: 1.97 kg (CI=0.97-2.97, p=0.0001), BMI z-score: 0.10 (CI: -0.01-0.20, p=0.0646) and WC z-score: 0.18 (CI: -0.09-0.45, p=0.1968). Lipid and glucose metabolism parameters increased significantly at week 4 and 12 only with quetiapine-ER (p-range: 0.0001-0.037). Quetiapine-ER was associated with an increased occurrence of obesity, elevated blood lipids and hyperinsulinemia (p-range=0.004-0.039). Early weight gain, obesity or type 2 diabetes in the family significantly predicted weight and BMI gain at week 12.
CONCLUSION: In youth with FEP, quetiapine-ER was associated with significantly greater weight gain and adverse changes in metabolic outcomes than aripiprazole. Early weight gain must be addressed and family lifestyle factors taken into consideration when treating youth with antipsychotics.
|Journal||Journal of the American Academy of Child and Adolescent Psychiatry|
|Number of pages||17|
|Publication status||Published - 2019|