p;232
21 (9%)
Bipolar Depression†
SEROQUEL XR
85
6 (7%)
Placebo
106
3 (3%)
Bipolar Mania‡
SEROQUEL XR
128
9 (7%)
Placebo
134
5 (4%)
Major Depressive Disorder (Adjunct Therapy)§
SEROQUEL XR
420
67 (16%)
Placebo
213
15 (7%)
Triglycerides ≥200 mg/dL
Schizophrenia*
SEROQUEL XR
658
118 (18%)
Placebo
214
11 (5%)
Bipolar Depression†
SEROQUEL XR
84
7 (8%)
Placebo
93
7 (8%)
Bipolar Mania‡
SEROQUEL XR
102
15 (15%)
Placebo
125
8 (6%)
Major Depressive Disorder (Adjunct Therapy)§
SEROQUEL XR
458
75 (16%)
Placebo
223
18 (8%)
LDL-Cholesterol ≥ 160 mg/dL
Schizophrenia*
SEROQUEL XR
691
47 (7%)
Placebo
227
17 (8%)
Bipolar Depression†
SEROQUEL XR
86
3 (4%)
Placebo
104
2 (2%)
Bipolar Mania‡
SEROQUEL XR
125
5 (4%)
Placebo
135
2 (2%)
Major Depressive Disorder (Adjunct Therapy)§
SEROQUEL XR
457
51 (11%)
Placebo
219
21 (10%)
HDL-Cholesterol ≤ 40 mg/dL
Schizophrenia*
SEROQUEL XR
600
87 (15%)
Placebo
195
23 (12%)
Bipolar Depression†
SEROQUEL XR
78
7 (9%)
Placebo
83
6 (7%)
Bipolar Mania‡
SEROQUEL XR
100
19 (19%)
Placebo
115
15 (13%)
Major Depressive Disorder (Adjunct Therapy)§
SEROQUEL XR
470
34 (7%)
Placebo
230
19 (8%)
In SEROQUEL clinical trials for schizophrenia, the percentage of patients with shifts in cholesterol and triglycerides from baseline to clinically significant levels were 18% (placebo: 7%) and 22% (placebo: 16%). HDL-cholesterol and LDL-cholesterol parameters were not measured in these studies. In SEROQUEL clinical trials for bipolar depression, the following percentage of patients had shifts from baseline to clinically significant levels for the four lipid parameters measured: total cholesterol 9% (placebo: 6%); triglycerides 14% (placebo: 9%); LDL-cholesterol 6% (placebo: 5%) and HDLcholesterol 14% (placebo: 14%). Lipid parameters were not measured in the bipolar mania studies.
Table 5 shows the percentage of patients in MDD adjunctive therapy trials with clinically significant shifts in total-cholesterol, triglycerides, LDL-cholesterol and HDL-cholesterol from baseline by dose .
Table 5: Percentage of Patients with Shifts in Total Cholesterol, Triglycerides, LDL-Cholesterol and HDL-Cholesterol from Baseline to Clinically Significant Levels in MDD
