Table 5.
Absolute and categorical changes in weight, total cholesterol, triglycerides, LDL, HDL, and glucose
|
Placebo |
Olanzapine |
p Value |
||
---|---|---|---|---|---|
n | LS mean (SE) | n | LS mean (SE) | ||
Weight gain, kg |
52 |
−0.36 (0.29) |
104 |
+2.12 (0.21) |
<.001 |
|
|
n/N (%) |
|
n/N (%) |
|
Patients with significant weight gain (≥7% body weight) |
|
1/52 (1.9) |
|
21/104 (20.2) |
.001 |
|
n |
LS mean (SE) |
n |
LS mean (SE) |
|
Baseline-to-endpoint change in fasting laboratory values |
|
|
|
|
|
Cholesterol, mg/dL |
52 |
−0.96 (3.37) |
104 |
+10.06 (2.38) |
.008 |
Triglycerides, mg/dL |
52 |
−4.17 (12.31) |
104 |
+30.67 (8.68) |
.02 |
LDL, mg/dL |
51 |
−1.06 (3.07) |
103 |
+8.78 (2.16) |
.01 |
HDL, mg/dL |
52 |
+1.10 (1.27) |
104 |
−2.99 (0.90) |
.01 |
Glucose, mg/dL |
51 |
−1.02 (1.11) |
100 |
+ 1.01 (0.79) |
.14 |
|
|
n/N (%) |
|
n/N (%) |
|
Patients with categorical shifts in fasting cholesterol values |
|
|
|
|
|
Normal to borderline |
|
2/17 (11.8) |
|
13/39 (33.3) |
.11 |
Normal to high |
|
0/17 (0.0) |
|
1/39 (2.6) |
1.00 |
Borderline to high |
|
0/25 (0.0) |
|
13/52 (25.0) |
.007 |
Patients with categorical shifts in fasting triglyceride values |
|
|
|
|
|
Normal to borderline |
|
3/37 (8.1) |
|
5/82 (6.1) |
.70 |
Normal to high |
|
1/37 (2.7) |
|
9/82 (11.0) |
.17 |
Normal to extremely high |
|
0/37 (0.0) |
|
0/82 (0.0) |
-- |
Borderline to high |
|
1/9 (11.1) |
|
3/12 (25.0) |
.60 |
Borderline to extremely high |
|
0/9 (0.0) |
|
0/12 (0.0) |
-- |
Patients with categorical shifts in fasting LDL cholesterol values |
|
|
|
|
|
Normal to borderline |
|
4/9 (44.4) |
|
11/26 (42.3) |
>.99 |
Normal to high |
|
0/9 (0.0) |
|
0/26 (0.0) |
-- |
Borderline to high |
|
0/34 (0.0) |
|
6/68 (8.8) |
.18 |
Patients with categorical shifts in fasting HDL cholesterol values |
|
|
|
|
|
Normal to low |
|
0/46 (0.0) |
|
8/97 (8.2) |
.05 |
Patients with categorical shifts in fasting glucose values |
|
|
|
|
|
Normal to impaired |
|
5/32 (15.6) |
|
9/72 (12.5) |
.76 |
Impaired to high |
|
0/18 (0.0) |
|
2/28 (7.1) |
.51 |
Normal/impaired to high |
|
0/50 (0.0) |
|
3/100 (3.0) |
.55 |
Normal to high | 0/32 (0.0) | 1/72 (1.4) | 1.00 |
Abbreviations: HDL = high-density lipoprotein; LDL = low-density lipoprotein; LS mean = least squares mean; SE = standard error.