ABILIFY (Page 6 of 24)
Pediatric Patients and Adolescents
Table 11 shows the proportion of adolescents with schizophrenia (13 to 17 years) and pediatric patients with bipolar disorder (10 to 17 years) with changes in total cholesterol and HDL cholesterol (pooled from two placebo-controlled trials; median exposure 42 to 43 days) and fasting triglycerides (pooled from two placebo-controlled trials; median exposure 42 to 44 days).
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| Total Cholesterol Normal to High (<170 mg/dL to ≥200 mg/dL) |
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| Fasting Triglycerides Normal to High (<150 mg/dL to ≥200 mg/dL) |
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| HDL Cholesterol Normal to Low (≥40 mg/dL to <40 mg/dL) |
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In monotherapy trials of adolescents with schizophrenia and pediatric patients with bipolar disorder, the proportion of patients at 12 weeks and 24 weeks with changes from Normal to High in total cholesterol (fasting/nonfasting), fasting triglycerides, and fasting LDL cholesterol were similar between ABILIFY- and placebo-treated patients: at 12 weeks, Total Cholesterol (fasting/nonfasting), 0/57 (0%) vs. 0/15 (0%); Fasting Triglycerides, 2/72 (2.8%) vs. 1/14 (7.1%), respectively; and at 24 weeks, Total Cholesterol (fasting/nonfasting), 0/36 (0%) vs. 0/12 (0%); Fasting Triglycerides, 1/47 (2.1%) vs. 1/10 (10.0%), respectively.
Table 12 shows the proportion of patients with changes in total cholesterol (fasting/nonfasting) and fasting triglycerides (median exposure 56 days) and HDL cholesterol (median exposure 55 to 56 days) from two placebo-controlled trials in pediatric patients (6 to 17 years) with irritability associated with autistic disorder.
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| Total Cholesterol Normal to High (<170 mg/dL to ≥200 mg/dL) |
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| Fasting Triglycerides Normal to High (<150 mg/dL to ≥200 mg/dL) |
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| HDL Cholesterol Normal to Low (≥40 mg/dL to <40 mg/dL) |
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Table 13 shows the proportion of patients with changes in total cholesterol (fasting/nonfasting) and fasting triglycerides (median exposure 57 days) and HDL cholesterol (median exposure 57 days) from two placebo-controlled trials in pediatric patients (6 to 18 years) with Tourette’s Disorder.
| Treatment Arm | n/N | % | |
| Total Cholesterol Normal to High (<170 mg/dL to ≥200 mg/dL) | ABILIFY | 1/85 | 1.2 |
| Placebo | 0/46 | 0 | |
| Fasting Triglycerides Normal to High (<150 mg/dL to ≥200 mg/dL) | ABILIFY | 5/94 | 5.3 |
| Placebo | 2/55 | 3.6 | |
| HDL Cholesterol Normal to Low (≥40 mg/dL to <40 mg/dL) | ABILIFY | 4/108 | 3.7 |
| Placebo | 2/67 | 3.0 |
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