In 2 long-term placebo-controlled randomized withdrawal clinical trials for bipolar maintenance, mean exposure of 213 days for SEROQUEL (646 patients) and 152 days for placebo (680 patients), the mean change in glucose from baseline was +5.0 mg/dL for quetiapine and –0.05 mg/dL for placebo. The exposure-adjusted rate of any increased blood glucose level (≥ 126 mg/dL) for patients more than 8 hours since a meal (however, some patients may not have been precluded from calorie intake from fluids during fasting period) was 18.0 per 100 patient years for SEROQUEL (10.7% of patients; n=556) and 9.5 for placebo per 100 patient years (4.6% of patients; n=581).

 Table 3 shows the percentage of patients with shifts in blood glucose to ≥ 126 mg/dL from normal baseline in MDD adjunct therapy trials by dose.

Table 3: Percentage of Patients with Shifts from Normal Baseline in Blood Glucose to ≥ 126 mg/dL (assumed fasting) in MDD Adjunct Therapy Trials by Dose

Table 3  Laboratory Analyte Treatment Arm N Patients n (%)
Blood Glucose ≥ 126 mg/dL
 Placebo
 277
 17 (6%)
 
SEROQUEL XR 150 mg
 280
 19 (7%)
 
SEROQUEL XR 300 mg
 269
 32 (12%)
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. In a placebo-controlled SEROQUEL monotherapy study of adolescent patients (13– 17 years of age) with schizophrenia (6 weeks duration), the mean change in fasting glucose levels for SEROQUEL (n=138) compared to placebo (n=67) was –0.75 mg/dL versus –1.70 mg/dL. In a placebo-controlled SEROQUEL monotherapy study of children and adolescent patients (10–17 years of age) with bipolar mania (3 weeks duration), the mean change in fasting glucose level for SEROQUEL (n=170) compared to placebo (n=81) was 3.62 mg/dL versus –1.17 mg/dL. No patient in either study with a baseline normal fasting glucose level (<100 mg/dL) or a baseline borderline fasting glucose level (≥100 mg/dL and <126 mg/dL) had a treatment-emergent blood glucose level of ≥126 mg/dL.
5.5 Hyperlipidemia
 Adults: Undesirable alterations in lipids have been observed with quetiapine use. Clinical monitoring, including baseline and periodic follow-up lipid eva luations in patients using quetiapine is recommended.

 Table 4 shows the percentage of patients with changes in cholesterol and triglycerides from baseline by indication in clinical trials with SEROQUEL XR .

 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

Table 4  Laboratory Analyte Indication Treatment Arm N Patients
n (%)
*
: 6 weeks duration
†
: 8 weeks duration
‡
: 3 weeks duration
§
: 6 weeks duration 
Total Cholesterol ≥240 mg/dL
 Schizophrenia*
 SEROQUEL XR
 718
 67 (9%)
 
Placebo
&nbs