Table 2.
Intention-to-Treat Analysis of Outcome Measures of Safety Among Randomized Patientsa
| |
|
Week 12b |
Week 24 |
|
|
|
||
|---|---|---|---|---|---|---|---|---|
| Measure | Therapy | n | Mean (SD) | n | Mean (SD) | F | df | p |
| Cholesterol | Clozapine | 13 | 171.5 (27.2) | 13 | 141.9 (55.5) | 0.79 | 1, 28 | 0.38 |
| Olanzapine | 17 | 180.0 (33.9) | 17 | 170.8 (38.2) | ||||
| Triglycerides | Clozapine | 13 | 161.0 (82.3) | 14 | 154.9 (65.9) | 0.07 | 1, 28 | 0.80 |
| Olanzapine | 17 | 134.9 (68.9) | 18 | 140.5 (72.0) | ||||
| Glucose | Clozapine | 13 | 96.2 (17.1) | 14 | 94.2 (10.9) | 0.03 | 1, 28 | 0.87 |
| Olanzapine | 17 | 84.1 (7.9) | 18 | 93.3 (15.1) | ||||
| Weight (kg) | Clozapine | 14 | 76.9 (11.9) | 13 | 76.3 (13.1) | 4.06 | 1, 29 | 0.05 |
| Olanzapine | 19 | 84.0 (18.8) | 18 | 87.0 (16.9) | ||||
| Body mass index (BMI) | Clozapine | 14 | 28.7 (3.6) | 13 | 28.5 (3.9) | 3.35 | 1, 29 | 0.08 |
| Olanzapine | 19 | 29.5 (5.6) | 19 | 30.2 (5.5) | ||||
| BMI percentilec | Clozapine | 14 | 93.7% (5.3) | 13 | 93.3% (6.3) | |||
| Olanzapine | 19 | 91.4% (10.7) | 18 | 92.1% (9.9) | ||||
| At healthy weightd | Clozapine | 14 | 1 (7.1%) | 14 | 2 (14.3%) | |||
| Olanzapine | 19 | 4 (21.1%) | 19 | 4 (21.1%) | ||||
| Overweighte | Clozapine | 14 | 7 (50.0%) | 14 | 5 (35.7%) | |||
| Olanzapine | 19 | 5 (26.3%) | 19 | 4 (21.1%) | ||||
| Obesef | Clozapine | 14 | 6 (42.9%) | 14 | 6 (42.9%) | |||
| Olanzapine | 19 | 10 (52.6%) | 19 | 10 (52.6%) | ||||
| Prolacting | Clozapine | 14 | 13.9 (8.3) | 14 | 18.2 (14.1) | 6.57 | 1, 27 | 0.02 |
| Olanzapine | 15 | 41.3 (39.7) | 15 | 23.6 (16.8) | ||||
Laboratory data are missing for some patients due to non-compliance, patient refusal and/or administrative reasons.
Unless otherwise indicated, data are presented as mean (standard deviation). Cholesterol, triglycerides, and glucose were obtained fasting.
Or trial endpoint. Using an intention-to-treat analysis, data are presented for subjects based on their initial randomization assignment to the clozapine or olanzapine group in the double blind study (Kumra et al 2008) regardless of which drug they received during the current open-label 12-week extension study.
Age adjusted. From: http://www.kidsnutrition.org/bodycomp/bmiz2.html/.
BMI percentile ≥5 to <85.
BMI percentile ≥85 to <95.
BMI percentile ≥95 (Koplan et al. 2005).
The mean threshold for abnormal prolactin values varied by laboratory (males, 
; females, 
).
SD = standard deviation.