Table 8.
Categoric Change in Metabolic Measures
| |
RCT |
OLE |
||||
|---|---|---|---|---|---|---|
| |
Ziprasidone |
Placebo |
Ziprasidone |
|||
| Category change from baseline | n | n (%) | n | n (%) | n | n (%) |
| Glucose | ||||||
| Normal to abnormal | 136 | 1 (0.7) | 60 | 2 (3.3) | 159 | 2 (1.3) |
| Borderline to abnormal | 19 | 0 | 16 | 0 | 23 | 2 (8.7) |
| Abnormal to normal | 4 | 2 (50.0) | 2 | 2 (100) | 5 | 3 (60.0) |
| Triglycerides | ||||||
| Normal to abnormal | 73 | 6 (8.2) | 34 | 6 (17.7) | 91 | 7 (7.8) |
| Borderline to abnormal | 45 | 16 (35.6) | 19 | 0 | 47 | 10 (21.3) |
| Abnormal to normal | 32 | 12 (37.5) | 21 | 4 (19.1) | 46 | 12 (26.1) |
| Cholesterol | ||||||
| Normal to abnormal | 110 | 1 (0.9) | 49 | 0 | 131 | 2 (1.5) |
| Borderline to abnormal | 39 | 7 (18.0) | 17 | 2 (11.8) | 45 | 8 (17.8) |
| Abnormal to normal | 15 | 5 (33.3) | 9 | 2 (22.2) | 14 | 6 (42.9) |
| LDL-C | ||||||
| Normal to abnormal | 116 | 1 (0.9) | 59 | 0 | 147 | 2 (1.4) |
| Borderline to abnormal | 23 | 4 (17.4) | 8 | 2 (25.0) | 28 | 3 (10.7) |
| Abnormal to normal | 11 | 4 (36.4) | 7 | 3 (42.9) | 9 | 2 (22.2) |
| HDL-C | ||||||
| Normal to abnormal | 126 | 12 (9.5) | 64 | 7 (10.9) | 155 | 6 (3.9) |
| Abnormal to normal | 24 | 16 (66.7) | 10 | 5 (50.0) | 29 | 14 (48.3) |
Glucose:<100 mg/dL - normal, 100–125 mg/dL - borderline,>125 mg/dL - abnormal.
Triglycerides:<90 mg/dL- normal, 90–130 mg/dL - borderline,>130 mg/dL - abnormal.
Cholesterol:<170 mg/dL - normal, 170–199 mg/dL - borderline,>199 mg/dL - abnormal.
LDL-C:<110 mg/dL - normal, 110–129 mg/dL - borderline,>129 - abnormal.
HDL-C:>= 35 mg/dL - normal,<35 - abnormal.
OLE, OLE, open-label extension; RCT, randomized controlled trial; LDL-C, low-density lipoprotein cholesterol; HDL-C, high-density lipoprotein cholesterol.