Table 6.
Vital Signs and Metabolic Measures
| |
RCT |
OLE |
|||||
|---|---|---|---|---|---|---|---|
| |
Ziprasidone |
Placebo |
Ziprasidone |
||||
| Baseline | Change from baseline to week 6 | Baseline | Change from baseline to week 6 | Baseline | Change from baseline to week 26 | Change from baseline to week 26/EOT | |
| Vital signs | |||||||
| Height (cm) | |||||||
| n | 193 | 135 | 90 | 52 | 221 | 75 | 203 |
| Mean±SD | 164.9±10.1 | 0.2±0.7 | 167.8±10.0 | 0.0±0.6 | 165.8±10.0 | 166.3±10.3 | 166.7±9.7 |
| Weight (kg) | |||||||
| n | 193 | 134 | 90 | 52 | 221 | 76 | 204 |
| Mean±SD | 61.2±15.5 | −0.1±2.4 | 64.3±15.7 | 0.0±2.0 | 61.7±14.5 | 1.7±5.6 | 0.7±4.6 |
| BMI z (kg/m2) | |||||||
| n | 193 | 134 | 90 | 52 | 221 | 75 | 203 |
| Mean±SD | 0.3±1.1 | 0.0±0.2 | 0.4±1.1 | 0.0±0.2 | 0.3±1.1 | 0.5±1.0 | 0.3±1.1 |
| Absolute BMI percentile | |||||||
| n | 193 | 134 | 90 | 52 | 221 | 75 | 203 |
| Mean±SD | 57.5±31.1 | 57.3±31.2 | 60.2±30.8 | 55.0±32.3 | 58.6±31.2 | 67.4±28.4 | 59.7±31.4 |
| Waist (cm) | |||||||
| n | 188 | 129 | 85 | 47 | 212 | 74 | 194 |
| Mean±SD | 76.9±12.9 | −0.2±2.7 | 78.0±13.1 | 0.1±2.8 | 77.2±11.8 | 1.1±6.5 | 0.3±5.1 |
| Supine hemodynamic measures | |||||||
| SBP (mm Hg) | |||||||
| n | 193 | 135 | 90 | 52 | 221 | 76 | 205 |
| Mean±SD | 113.6±9.2 | −0.6±9.7 | 113.7±8.5 | 2.8±8.6 | 114.6±9.9 | −0.9±11.4 | −1.2±10.4 |
| DBP (mm Hg) | |||||||
| n | 193 | 135 | 90 | 52 | 221 | 76 | 205 |
| Mean±SD | 71.0±8.5 | −0.9±7.7 | 72.1±7.6 | 1.0±6.8 | 71.6±8.9 | −0.1±7.7 | −1.1±9.0 |
| Pulse (bpm) | |||||||
| n | 193 | 135 | 90 | 52 | 221 | 76 | 205 |
| Mean±SD | 76.0±10.5 | −1.3±11.3 | 77.1±10.7 | −1.1 (11.4) | 75.7±10.4 | −1.6±11.5 | −0.7±11.8 |
| QTcF (ms) | |||||||
| n | 193 | 134 | 89 | 52 | 221 | 73 | 179 |
| Mean±SD | 392.0±17.3 | 5.1±15.9 | 389.9±20.1 | 0.3±17.0 | 392.0±16.7 | 4.3±20.3 | 3.8±18.9 |
| Metabolic measures | |||||||
| Fasting glucose (mg/dL) | |||||||
| n | 159 | 115 | 78 | 48 | 182 | 63 | 146 |
| Mean±SD | 90.0±16.1 | −2.8±18.8 | 91.3±14.0 | 3.2±17.0 | 90.8±16.3 | 1.1±12.9 | 1.2±18.8 |
| Insulin (μU/dL) | |||||||
| n | 145 | 112 | 68 | 38 | 36 | 11 | 24 |
| Mean±SD | 17.7±47.6 | −1.2±30.8 | 13.1±17.9 | 7.3±22.3 | 15.0±17.1 | −3.9±24.1 | 3.8±25.9 |
| Total fasting cholesterol (mg/dL) | |||||||
| n | 164 | 125 | 75 | 50 | 185 | 69 | 156 |
| Mean±SD | 158.9±31.3 | −8.3±25.4 | 158.9±30.7 | −5.3±20.2 | 157.0±30.8 | −4.0±30.0 | −5.8±27.6 |
| Fasting HDL-C (mg/dL) | |||||||
| n | 150 | 115 | 74 | 49 | 179 | 63 | 146 |
| Mean±SD | 48.1±12.1 | −0.4±9.4 | 48.2±12.2 | −1.3±10.2 | 47.6±11.8 | 2.2±12.1 | 0.3±11.2 |
| Fasting LDL-C (mg/dL) | |||||||
| n | 150 | 115 | 74 | 49 | 179 | 63 | 146 |
| Mean±SD | 91.7±25.7 | −7.5±19.2 | 89.6±25.0 | −2.6±16.9 | 89.5±25.1 | −5.3±24.5 | −5.0±22.8 |
| Fasting triglycerides (mg/dL) | |||||||
| n | 150 | 115 | 74 | 49 | 179 | 63 | 146 |
| Mean±SD | 102.7±50.1 | −3.9±63.6 | 114.1±73.2 | −13.2±85.9 | 107.0±63.8 | −4.1±55.2 | −7.1±61.8 |
Normal values for fasting glucose: 60–<100 mg/dL, insulin: 6–27 μmol/dL, total cholesterol: 85–169 mg/dL, HDL-C: 40–75 mg/dL, LDL-C: 62–129 mg/dL, triglycerides: 26–109 mg/dL.
BMI, body mass index; bpm, beats/min; DBP, diastolic blood pressure; EOT, end of treatment; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; OLE, open-label extension; QTcF, Fridericia-corrected QT interval; RCT, randomized controlled trial; SBP, systolic blood pressure.