Quetiapine (Page 4 of 14)
Dyslipidemia
Adults:
Table 4 shows the percentage of adult patients with changes in total cholesterol, triglycerides, LDL-cholesterol, and HDL-cholesterol from baseline by indication in clinical trials with quetiapine.
Laboratory Analyte | Indication | Treatment Arm | N | Patients n (%) |
---|---|---|---|---|
Total Cholesterol ≥ 240 mg/dL | Schizophrenia * | Quetiapine | 137 | 24 (18%) |
Placebo | 92 | 6 (7%) | ||
Bipolar Depression † | Quetiapine | 463 | 41 (9%) | |
Placebo | 250 | 15 (6%) | ||
Triglycerides ≥200 mg/dL | Schizophrenia * | Quetiapine | 120 | 26 (22%) |
Placebo | 70 | 11 (16%) | ||
Bipolar Depression † | Quetiapine | 436 | 59 (14%) | |
Placebo | 232 | 20 (9%) | ||
LDL-Cholesterol ≥ 160 mg/dL | Schizophrenia * | Quetiapine | na ‡ | na ‡ |
Placebo | na ‡ | na ‡ | ||
Bipolar Depression † | Quetiapine | 465 | 29 (6%) | |
Placebo | 256 | 12 (5%) | ||
HDL-Cholesterol ≤ 40 mg/dL | Schizophrenia * | Quetiapine | na ‡ | na ‡ |
Placebo | na ‡ | na ‡ | ||
Bipolar Depression † | Quetiapine | 393 | 56 (14%) | |
Placebo | 214 | 29 (14%) |
Children and Adolescents:
Table 5 shows the percentage of children and adolescents with changes in total cholesterol, triglycerides, LDL-cholesterol, and HDL-cholesterol from baseline in clinical trials with quetiapine.
Laboratory Analyte | Indication | Treatment Arm | N | Patients n (%) |
---|---|---|---|---|
Total Cholesterol ≥ 200 mg/dL | Schizophrenia * | Quetiapine | 107 | 13 (12%) |
Placebo | 56 | 1 (2%) | ||
Bipolar Mania † | Quetiapine | 159 | 16 (10%) | |
Placebo | 66 | 2 (3%) | ||
Triglycerides ≥150 mg/dL | Schizophrenia * | Quetiapine | 103 | 17 (17%) |
Placebo | 51 | 4 (8%) | ||
Bipolar Mania † | Quetiapine | 149 | 32 (22%) | |
Placebo | 60 | 8 (13%) | ||
LDL-Cholesterol ≥ 130 mg/dL | Schizophrenia * | Quetiapine | 112 | 4 (4%) |
Placebo | 60 | 1 (2%) | ||
Bipolar Mania † | Quetiapine | 169 | 13 (8%) | |
Placebo | 74 | 4 (5%) | ||
HDL-Cholesterol ≤ 40 mg/dL | Schizophrenia * | Quetiapine | 104 | 16 (15%) |
Placebo | 54 | 10 (19%) | ||
Bipolar Mania † | Quetiapine | 154 | 16 (10%) | |
Placebo | 61 | 4 (7%) |
In a placebo-controlled quetiapine extended release monotherapy study (8 weeks duration) of children and adolescent patients (10 to 17 years of age) with bipolar depression, in which efficacy was not established, the percentage of children and adolescents with shifts in total cholesterol (≥200 mg/dL), triglycerides (≥150 mg/dL), LDL-cholesterol (≥130 mg/dL), and HDL-cholesterol (≤40 mg/dL) from baseline to clinically significant levels were: total cholesterol 8% (7/83) for quetiapine extended release vs. 6% (5/84) for placebo; triglycerides 28% (22/80) for quetiapine extended release vs. 9% (7/82) for placebo; LDL-cholesterol 2% (2/86) for quetiapine extended release vs. 4% (3/85) for placebo and HDL-cholesterol 20% (13/65) for quetiapine extended release vs. 15% (11/74) for placebo.
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