Table 5  Laboratory Analyte Treatment Arm* N Patients
n (%)
*
: 6 weeks duration 
Cholesterol ≥ 240 mg/dL
 Placebo
 213
 15 (7%)
 
SEROQUEL XR 150 mg
 223
 41 (18%)
 
SEROQUEL XR 300 mg
 197
 26 (13%)
 
Triglycerides ≥ 200 mg/dL
 Placebo
 223
 18 (8%)
 
SEROQUEL XR 150 mg
 232
 36 (16%)
 
SEROQUEL XR 300 mg
 226
 39 (17%)
 
LDLCholesterol ≥ 160 mg/dL
 Placebo
 219
 21 (8%)
 
SEROQUEL XR 150 mg
 242
 29 (16%)
 
SEROQUEL XR 300 mg
 215
 22 (17%)
 
HDL-Cholesterol ≤ 40 mg/dL
 Placebo
 230
 19 (8%)
 
SEROQUEL XR 150 mg
 238
 14 (6%)
 
SEROQUEL XR 300 mg
 232
 20 (9%)
Children and Adolescents:

Safety and effectiveness of SEROQUEL XR have not been established in pediatric patients, and SEROQUEL XR is not approved for patients under the age of 18 years.

 Table 6 shows the percentage of children and adolescents with shifts in total cholesterol, triglycerides, LDL-cholesterol and HDL-cholesterol from baseline to clinically significant levels by indication in clinical trials with SEROQUEL.

 Table 6: Percentage of Children and Adolescents with Shifts in Total Cholesterol, Triglycerides LDL-Cholesterol and HDLCholesterol from Baseline to Clinically Significant Levels by Indication

Table 6  Laboratory Analyte Indication Treatment Arm N Patients n (%)
*
: 13- 17 years, 6 weeks duration
†
: 10-17 years, 3 weeks duration 
Total Cholesterol ≥ 200 mg/dL
 Schizophrenia*
 SEROQUEL
 107
 13 (12%)
 
Placebo
 56
 1 (2%)
 
Bipolar Mania†
 SEROQUEL
 159
 16 (10%)
 
Placebo
 66
 2 (3%)
 
Triglycerides ≥150 mg/dL
 Schizophrenia*
 SEROQUEL
 103
 17 (17%)
 
Placebo
 51
 4 (8%)
 
Bipolar Mania†
 SEROQUEL
 149
 32 (22%)
 
Placebo
 60
 8 (13%)
 
LDL-Cholesterol ≥ 130 mg/dL
 Schizophrenia*
 SEROQUEL
 112
 4 (4%)
 
Placebo
 60
 1 (2%)
 
Bipolar Mania†
 SEROQUEL
 169
 13 (8%)
 
Placebo
 74
 4 (5%)
 
HDL-Cholesterol ≤ 40 mg/dL
 Schizophrenia*
 SEROQUEL
 104
 16 (15%)
 
Placebo
 54
 10 (19%)
 
Bipolar Mania†
 SEROQUEL
 154
 16 (10%)
 
Placebo
 61
 4 (7%)
5.6 Weight Gain
 Increases in weight have been observed in clinical trials. Patients receiving quetiapine should receive regular monitoring of weight [see Patient Counseling Information (17)].

Adults: Table 7 shows the percentage of adult patients with weight gain of ≥7% of body weight by indication.

Table 7: Percentage of Patients with Weight Gain ≥7% of Body Weight (Adul