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.

Table 4: Percentage of Adult Patients with Shifts in Total Cholesterol, Triglycerides, LDL-Cholesterol, and HDL-Cholesterol from Baseline to Clinically Significant Levels by Indication
Laboratory Analyte Indication Treatment Arm N Patients n (%)
*
6 weeks duration
8 weeks duration
Parameters not measured in the quetiapine registration studies for schizophrenia.

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.

Table 5: Percentage of Children and Adolescents with Shifts in Total Cholesterol, Triglycerides, LDL-Cholesterol, and HDL-Cholesterol from Baseline to Clinically Significant Levels
Laboratory Analyte Indication Treatment Arm N Patients n (%)
*
13 to 17 years, 6 weeks duration
10 to 17 years, 3 weeks duration

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.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.