Table 6.
Mean Changes in Individual Metabolic Criteria at End of Phase 1 Visit
| Waist Circumference†(inches) | Systolic BP†(mm Hg) | Diastolic BP (mm Hg) | HDL@‡(mg/dl) (Whites) | HDL@(mg/dl) (Non-Whites) | Fasting Glucose (mg/dl) | Fasting Triglycerides†(mg/dl) | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| Below Median | Above Median | Below Median | Above Median | Below Median | Above Median | |||||
| Mean Exposure (months) | 8.9 | 8.7 | 8.7 | 9.1 | 8.9 | 9.2 | 9.9 | 9.9 | 9.9 | 9.8 |
| OLANZ | 1.9 (SE=0.2) (n=146) |
0.4 (SE=0.3) (n=147) |
6.0 (SE=1.0) (n=159) |
−3.6 (SE=1.2) (n=146) |
0.1 (SE=0.6) (n=305) |
−1.7 (SE=0.6) (n=171) |
−0.9 (SE=0.9) (n=115) |
4.5 (SE=2.3) (n=94) |
49.0 (SE=10.8) (n=42) |
5.2 (SE=17.4) (n=51) |
| RISP | 0.9 (SE=0.2) (n=145) |
−0.7 (SE=0.3) (n=143) |
5.6 (SE=1.1) (n=136) |
−9.0 (SE=1.1) (n=162) |
−1.3 (SE=0.6) (n=298) |
0.1 (SE=0.6) (n=162) |
0.9 (SE=0.9) (n=109) |
−0.4 (SE=2.6) (n=74) |
19.7 (SE=11.2) (n=39) |
−67.1 (SE=21.2) (n=35) |
| QUET | 0.7 (SE=0.2) (n=142) |
0.0 (SE=0.2) (n=157) |
8.6 (SE=1.0) (n=158) |
−8.0 (SE=1.2) (n=145) |
−0.1 (SE=0.6) (n=303) |
−0.2 (SE=0.6) (n=186) |
0.1 (SE=1.1) (n=85) |
−1.8 (SE=2.4) (n=88) |
29.8 (SE=10.8) (n=42) |
−13.0 (SE=18.4) (n=46) |
| ZIP | 0.0 (SE=0.3) (n=77) |
−0.4 (SE=0.3) (n=78) |
8.8 (SE=1.5) (n=78) |
−7.6 (SE=1.6) (n=80) |
−0.4 (SE=0.8) (n=158) |
0.6 (SE=0.9) (n=90) |
4.3 (SE=1.4) (n=51) |
0.0 (SE=3.5) (n=39) |
26.0 (SE=15.6) (n=20) |
−96.4 (SE=28.5) (n=19) |
| PER | 0.6 (SE=0.2) (n=126) |
−1.1 (SE=0.3) (n=110) |
6.0 (SE=1.2) (n=107) |
−6.4 (SE=1.2) (n=137) |
0.0 (SE=0.6) (n=243) |
2.7 (SE=0.7) (n=130) |
−1.3 (SE=1.0) (n=88) |
−1.0 (SE=2.7) (n=68) |
28.7 (SE=11.6) (n=36) |
−27.5 (SE=22.3) (n=31) |
| Overall Treatment Difference | < .0011 | .0012 | NS | .0173 | NS | <.0014 | 0.0125 | NS | NS | 0.0116 |
Table entries are ANCOVA least squares adjusted means. All models include time to treatment discontinuation as a covariate, as well as baseline value of outcome. Demographic variables were analyzed, but only age and race entered the models for HDL, SBP and DBP, and gender for HDL and SBP.
Note: NS = not significant (p≥.05)
Data presented in separate columns due to significant baseline by treatment effect. Median WC = 39 in, median SBP = 122 mm Hg, median TG =148 mg/dl.
Data presented in separate columns due to significant race by treatment effect.
There was a significant ziprasidone cohort effect, but the between-group results were not different for cohorts enrolled prior to, or after the introduction of ziprasidone.
Between group comparison significant for olanzapine vs. rispeidone (p=.001), quetiapine (p<.001), ziprasidone (p<.001), perphenazine (p<.001).
Between group comparison significant for perphenazine vs. olanzapine (p<.001), perphenazine vs. quetiapine (p=.003), and olanzapine vs. risperidone (p=.003).
Between group comparison significant for olanzapine vs. risperidone (p=.001).
Between group comparison significant for perphenazine vs. olanzapine (p<.001), and perphenazine vs. quetiapine (p=.002).
Between group comparisons significant for ziprasidone vs. olanzapine (p=.002), and ziprasidone vs. perphenazine (p=.001).
Between group comparisons significant for olanzapine vs. ziprasidone (p=.003).