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SO003

Safety and tolerability of second-generation antipsychotics in a pediatric cohort: a real-world longitudinal study

SAFETY AND TOLERABILITY OF SECOND-GENERATION ANTIPSYCHOTICS IN A PEDIATRIC COHORT: A REAL LIFE LONGITUDINAL STUDY

Over six months of follow-up, cardiovascular, hepatic, and lipid profiles remained stable with second-generation antipsychotics, but substantial increases in weight, waist circumference, and prolactin were observed, particularly with risperidone.

The study aimed to evaluate the six-month cardiometabolic, endocrine, and cardiovascular safety of second-generation antipsychotics (SGAs) in children and adolescents under naturalistic follow-up conditions. This prospective observational study enrolled 68 patients aged 6–17 years (13.5±2.7 years; 64.7% male; mean number of comorbidities per patient: 1.59±0.98). Anthropometric measures, blood pressure, resting heart rate, QTc (Bazett) on a 12-lead ECG, and laboratory parameters were assessed at baseline (T0), month 3 (T1), and month 6 (T2). Longitudinal trajectories and between-drug differences (Time x Drug interaction) were examined using linear mixed-effects models (LMMs) adjusted for age, biological sex, and socioeconomic status. Primary diagnoses comprised conduct disorder (n=18, 26.5%), ADHD (n=14, 20.6%), obsessive-compulsive disorder (n=11, 16.2%), autism spectrum disorder (n=10, 14.7%), bipolar disorder (n=9, 13.2%), and other diagnoses (n=6, 8.8%). Treatments were risperidone (n=30, 44.1%), aripiprazole (n=20, 29.4%), quetiapine (n=7, 10.3%), combined risperidone and aripiprazole (n=7, 10.3%), and lurasidone (n=4, 5.9%), with a six-month treatment retention rate of 91.2% (62/68). Across the full sample, body weight (β=+4.87 kg, p<0.001) and waist circumference (β=+2.90 cm, p<0.001) increased significantly; blood pressure and heart rate remained stable (p>0.17), while QTc increased slightly (+6.0 ms, p=0.018), with no patient reaching a QTc of 430 ms. Transaminases and lipid profiles remained generally stable (p>0.05), while slight increases in gamma-GT and prolactin were detected (p<0.05). Risperidone was associated with greater increases in weight (β=+2.72 kg, p=0.037) and waist circumference (β=+5.64 cm, p<0.001) than aripiprazole. Prolactin increased with risperidone but remained stable with aripiprazole (Time x Drug interaction p<0.001), and slight increases in ALT and total cholesterol were observed only in the risperidone group (p<0.05). At baseline, patients receiving risperidone were younger (12.1 versus 14.0 years, p=0.007), while other baseline measures were similar between groups (p>0.05). Adverse events were mild and transient in 5 patients, and 2 patients discontinued treatment because of aripiprazole-related akathisia/activation. The authors conclude that the safety profile was maintained over the medium term, but that increases in weight and central adiposity, particularly with risperidone, warrant percentile-based metabolic monitoring from the start of treatment. They note that the small sample size and naturalistic follow-up design limit causal inference.

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